A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults With Chronic Primary Immune Thrombocytopenia

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time.
Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met.
During the study, participants will visit their study clinic several times.

开始日期2025-08-14

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06963827

/ Recruiting临床3期

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy

Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo.
Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed in 1 of the 2 treatment groups by chance (either mezagitamab or placebo) at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. The participants will receive either mezagitamab or placebo for almost half a year in two 1-year cycles. They will be observed for another half year in each 1-year cycle and will have check-ups about every month during this time.
In the open-label group, a small number of participants who have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab.
During the study, participants will visit their study clinic several times.

开始日期2025-07-15

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06722235

/ Recruiting临床3期

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants With Chronic Primary Immune Thrombocytopenia

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously [SC]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it.
The participants will be treated with mezagitamab for up to 6 months.
During the study, participants will visit their study clinic several times.
Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).

开始日期2025-02-27

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与 Mezagitamab 相关的临床结果

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100 项与 Mezagitamab 相关的转化医学

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100 项与 Mezagitamab 相关的专利（医药）

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项与 Mezagitamab 相关的文献（医药）

2026-04-01·Current Opinion in Organ Transplantation

Managing the highly sensitized kidney transplant patient

Review

作者: Jackson, Kyle R. ; Parsons, Ronald F.

Purpose of review:

Highly sensitized kidney transplant candidates, particularly those with calculated panel reactive antibody (CPRA) ≥99.9%, face significant immunologic barriers to transplantation. This review highlights recent clinical strategies that have improved transplant access and outcomes in this population, with a focus on allocation policy, kidney-paired donation, and desensitization.

Recent findings:

Updates from national allocation systems and kidney-paired donation programs have demonstrated substantial gains in transplant access for many highly sensitized candidates. However, those with CPRA at least 99.9% remain difficult to match. Novel desensitization approaches, such as imlifidase, proteasome inhibitors, anti-CD38 mAbs, and early-phase CAR T-cell therapies have shown promise in selected patients. Increasingly, immunologic phenotyping or gene expression profiling may help tailor desensitization strategies to individual recipients.

Summary:

Most highly sensitized candidates now achieve transplant through allocation policy or paired donation. For those with CPRA at least 99.9%, desensitization will likely remain an important tool to facilitate transplantation. Emerging therapies and immunologic profiling may help individualize treatment and expand transplant access for this challenging group.

2026-01-01·Current Research in Translational Medicine

The efficacy and safety of anti-CD38 monoclonal antibodies in transplant-ineligible newly diagnosed multiple myeloma: A systematic review and meta-analysis of randomized controlled trials

Article

作者: Alamy, Haroon ; Huynh, Huu Than ; Shelar, Vrushali ; El Amri, Imane ; Shah, Hafiz ; Ibrahim Ahmad, Feras Ahmad ; Aliyeva, Turkan ; Natche, Julia

BACKGROUND:

Treatment of transplant-ineligible newly diagnosed multiple myeloma (TIE-NDMM) remains challenging due to age, frailty, and comorbidities. Anti-CD38 monoclonal antibodies, particularly daratumumab, have emerged as promising additions to frontline regimens. However, the long-term outcomes of these therapies are still uncertain. This systematic review and meta-analysis aimed to compare the survival outcome of anti-CD38 antibodies in TIE-NDMM patients.

METHODS:

We systematically searched PubMed, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) published up to April 2025 comparing anti-CD38 mAbs based regimens versus standard therapy in transplant-ineligible NDMM patients. A random-effects model was used to calculate pooled hazard ratios (HRs) with 95 % confidence intervals (CIs).

RESULTS:

A total of six RCTs with 2,625 patients were included in the analysis. Of these, 1,390 (52.9 %) patients received anti-CD38-based regimens. The follow-up duration varied from 41.2 to 86.7 months across the studies. Compared to standard therapy, anti-CD38-based regimens significantly improved both overall survival (OS) (HR 0.70; 95 % CI 0.58-0.84; p=0.0002; I² = 46 %) and progression-free survival (PFS) (HR 0.57; 95 % CI 0.51-0.65; p < 0.00001; I² = 15 %). The pooled results demonstrated that non-frail patients had a longer PFS than frail patients (HR = 0.46; 95 % CI, 0.34-0.63 and HR = 0.55; 95 % CI, 0.45-0.67, respectively), although the difference between the subgroups was not statistically significant (p = 0.36).

CONCLUSION:

In transplant-ineligible NDMM patients, the addition of anti-CD38 monoclonal antibodies to standard regimens significantly improves clinical outcomes. These findings support the integration of anti-CD38 therapy into first-line treatment for this vulnerable patient population.

2025-12-05·Hematology-American Society of Hematology Education Program

Choosing the optimal maintenance strategy in multiple myeloma

Review

作者: Puliafito, Benjamin ; Raje, Noopur ; Cirstea, Diana

Abstract:

While lenalidomide has been the established standard of care for maintenance after autologous stem cell transplantation in newly diagnosed multiple myeloma, risk-adapted maintenance strategies with the addition of proteasome inhibitors can provide additional benefit in high-risk disease. The widespread use of anti-CD38 monoclonal antibodies (mAbs) in induction and consolidation has further disrupted this paradigm, offering the use of anti-CD38 mAbs in maintenance. Novel immunotherapeutic approaches and minimal residual disease–guided maintenance strategies are being actively investigated. The evolution of maintenance strategies provides a window to a future where maintenance therapy is not only more effective at sustaining deep and durable responses but also more dynamic with careful de-escalation strategies.

项与 Mezagitamab 相关的新闻（医药）

2026-03-31

·bioinvent.com

BioInvent International AB publishes Annual Report 2025

Lund, Sweden – March 31, 2026 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immunomodulatory antibodies for cancer immunotherapy, today announced that the Annual Report for 2025 has been published. The Annual Report is attached to this press release in pdf format and is available on the company’s website www.bioinvent.com. BioInvent’s key achievements in 2025 centered on advancing the lead programs BI-1808 and BI-1206 into mid-stage clinical development, presenting encouraging data at major scientific meetings, and strengthening the financial and strategic position. “During 2025 we sharpened our clinical focus and resource allocation to accelerate our most advanced assets, BI-1808 (anti-TNFR2) and BI-1206 (anti-FcγRIIB), while pausing earlier stage programs to maximize the probability of success and near-term value creation. This portfolio optimization reflects a disciplined approach to development and partnering, aligning investment with the strongest clinical signals and upcoming milestones. In summary, 2025 was a year of clinical validation and strategic consolidation. We advanced our most promising programs into Phase 2a, delivered encouraging data, and controlled our financial position through disciplined portfolio management and royalty monetization.” – Martin Welschof, CEO of BioInvent. KEY EVENTS IN 2025• (R) Promising early Phase 2a monotherapy data for the company’s lead anti-TNFR2 antibody BI-1808 in T-cell lymphoma (TCL) presented at ASH 2025• (R) Impressive response data from ongoing Phase 2a trial of triple combination of the company’s lead anti-FcyRIIB antibody BI-1206, rituximab, and Calquence® in r/r non-Hodgkin’s Lymphoma (NHL) presented at ASH 2025• Phase 2a trial started evaluating BI-1206 in combination with pembrolizumab in treatment naïve advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma• Orphan Drug Designation from EMA for BI‑1808 for the treatment of cutaneous T-cell lymphoma (CTCL)• (R) Positive initial efficacy data from Phase 2a trial of triple combination of BI-1206, rituximaband Calquence® for the treatment of NHL• BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency• (R) Promising Phase 2a monotherapy data for BI-1808 in CTCL presented at EHA 2025• Promising Phase 1 data of BI-1206 in combination with KEYTRUDA® (pembrolizumab) in solid tumors announced• (R) XOMA Royalty purchased mezagitamab royalty and milestone rights held by BioInvent for up to USD 30 million• FDA Fast Track Designation received for BI-1808 for the treatment of CTCL• BI-1808 received Orphan Drug Designation from FDA for the treatment of TCL (R)= Regulatory event In line with the information in the Year-end report for 2025 issued end of February 2026, it is the Board of Directors’ and the CEO’s assessment that the company is, based on ongoing projects, financed into the latter part of Q1 2027. The Board of Directors and the CEO continuously evaluate various options to finance the company’s activities, but since no such financing has been secured at the time of signing of the annual report, this indicates an uncertainty. However, the Board of Directors and the CEO assess that there are good possibilities for future financing solutions. See page 35 and 69 of the annual report. EXPECTED KEY CATALYSTS 2026 The priorities for 2026 are clear: complete the ovarian cancer cohort expansion with BI-1808 and report data in H2 2026; continue to optimize BI-1808 development for CTCL; and progress BI-1206 in NHL as datasets mature and partnering opportunities develop. By the second half of this year, we expect to have the first data from the BI-1206 Phase 2a study in first-line NSCLC. Mid-2026:• First combination data for BI-1808 and pembrolizumab for the treatment of cutaneous T-cell lymphoma (CTCL), as well as additional CTCL monotherapy data• Additional data for BI-1206 triplet combination for the treatment of non-Hodgkin’s lymphoma (NHL)H2 2026:• Additional Phase 2a data for BI-1808 in combination with Keytruda (pembrolizumab) for the treatment of solid tumors• First read-out from the Phase 2a study of BI-1206 in combination with pembrolizumab for treatment-naïve NSCLC patients and uveal melanoma patients. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with drug candidates in ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com. For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.comBioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.com The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release. This information is information that BioInvent International is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-03-31 11:45 CEST.

临床结果孤儿药免疫疗法临床2期快速通道

2026-02-26

·bioinvent.com

BioInvent International AB: Year-end report January 1 – December 31, 2025

“During 2025 we sharpened our clinical focus and resource allocation to accelerate our most advanced assets, BI-1808 (anti-TNFR2) and BI-1206 (anti-FcγRIIB), while pausing earlier programs to maximize the probability of success and near-term value creation.”- Martin Welschof, CEO BioInvent. EVENTS IN THE FOURTH QUARTER (R) Promising early Phase 2a monotherapy data for the company’s lead anti-TNFR2 antibody BI-1808 in T-cell lymphoma (TCL) presented at ASH 2025 (R) Impressive response data from ongoing Phase 2a trial of triple combination of the company’s lead anti-FcyRIIB antibody BI-1206, rituximab, and Calquence® in r/r non-Hodgkin’s Lymphoma (NHL) presented at ASH 2025 Phase 2a trial started evaluating BI-1206 in combination with pembrolizumab in treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma Orphan Drug Designation from EMA for BI‑1808 for the treatment of cutaneous T-cell lymphoma (CTCL) Phase 1 data of the company’s second anti-TNFR2 antibody BI-1910 (currently paused) presented at SITC 2025 validates TNFR2 as a novel immunotherapy approach in advanced solid tumors Transgene and BioInvent presented translational data and updated clinical results on armed oncolytic virus BT-001 at ESMO 2025 BioInvent announced publication of preclinical and early clinical data for BI-1607 in HER2-positive advanced solid tumors EVENTS AFTER THE END OF THE PERIOD (R) Promising data in ongoing Phase 2a study for BI-1808 with KEYTRUDA® (pembrolizumab) for the treatment of recurrent ovarian cancer Updated clinical data sets solidify potential for both BI-1808 and pembrolizumab combination in ovarian cancer and BI-1206 triplet for the treatment of NHL, see pages 6 and 7 in the year-end report Nomination of two new board members ahead of 2026 Annual General Meeting; Kate Hermans and Scott Zinober EARLIER DURING 2025, IN BRIEF (R) Positive initial efficacy data from Phase 2a trial of triple combination of BI-1206, rituximab and Calquence® for the treatment of NHL BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency (R) Promising Phase 2a monotherapy data for BI-1808 in CTCL presented at EHA 2025 Promising Phase 1 data of BI-1206 in combination with KEYTRUDA® (pembrolizumab) in solid tumors announced (R) XOMA Royalty purchased mezagitamab royalty and milestone rights held by BioInvent for up to USD 30 million Composition of matter patents for BI-1808 granted in US and Japan. They also cover the use of the antibody in the treatment of cancer FDA Fast Track Designation received for BI-1808 for the treatment of CTCL BI-1808 received Orphan Drug Designation from FDA for the treatment of TCL Strategic changes in portfolio to accelerate lead clinical programs and enhance value creation (R)= Regulatory event FINANCIAL INFORMATION Fourth quarter 2025• Net sales SEK 3.0 (21.4) million• Profit/loss after tax SEK -125.8 (-116.9) million• Profit/loss after tax per share before and after dilution SEK –1.91 (-1.78)• Cash flow from operating activities SEK-90.6 (-98.3) million January – December 2025• Net sales SEK 226.5 (44.7) million• Profit/loss after tax SEK -332.9 (-429.4) million• Profit/loss after tax per share before and after dilution SEK -5.06 (-6.53)• Cash flow from operating activities SEK -247.8 (-380.5) million• Liquid funds, current and long-term investments as of December 31, 2025: SEK 592.7 (867.2) million The complete interim report is available for download below and on the company’s website under Financial reports. INVITATION TO PRESENTATION OF THE YEAR-END REPORT 2025BioInvent’s CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in English.When: Thursday February 26, 2026, at 2:00 pm CET The webcast can be reached at https://bioinvent.events.inderes.com/q4-report-2025. If you wish to ask questions and participate via telephone, please register at the link below. After registration you will be provided with a phone number and a conference ID to access the conference.https://events.inderes.com/bioinvent/q4-report-2025/dial-in. The conference call will be made available on the company website after the call. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with drug candidates in ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com. For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.comBioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.com

临床结果孤儿药免疫疗法临床2期临床1期

2026-02-26

·BioSpace

BioInvent International AB: Year-End Report January 1 - December 31, 2025

LUND, SE / ACCESS Newswire / February 26, 2026 / BioInvent International (STO:BINV) - "During 2025 we sharpened our clinical focus and resource allocation to accelerate our most advanced assets, BI-1808 (anti-TNFR2) and BI-1206 (anti-FcγRIIB), while pausing earlier programs to maximize the probability of success and near-term value creation."- Martin Welschof, CEO BioInvent. EVENTS IN THE FOURTH QUARTER (R) Promising early Phase 2a monotherapy data for the company's lead anti-TNFR2 antibody BI-1808 in T-cell lymphoma (TCL) presented at ASH 2025 (R) Impressive response data from ongoing Phase 2a trial of triple combination of the company's lead anti-FcyRIIB antibody BI-1206, rituximab, and Calquence® in r/r non-Hodgkin's Lymphoma (NHL) presented at ASH 2025 Phase 2a trial started evaluating BI-1206 in combination with pembrolizumab in treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma Orphan Drug Designation from EMA for BI‑1808 for the treatment of cutaneous T-cell lymphoma (CTCL) Phase 1 data of the company's second anti-TNFR2 antibody BI-1910 (currently paused) presented at SITC 2025 validates TNFR2 as a novel immunotherapy approach in advanced solid tumors Transgene and BioInvent presented translational data and updated clinical results on armed oncolytic virus BT-001 at ESMO 2025 BioInvent announced publication of preclinical and early clinical data for BI-1607 in HER2-positive advanced solid tumors EVENTS AFTER THE END OF THE PERIOD (R) Promising data in ongoing Phase 2a study for BI-1808 with KEYTRUDA® (pembrolizumab) for the treatment of recurrent ovarian cancer Updated clinical data sets solidify potential for both BI-1808 and pembrolizumab combination in ovarian cancer and BI-1206 triplet for the treatment of NHL, see pages 6 and 7 in the year-end report Nomination of two new board members ahead of 2026 Annual General Meeting; Kate Hermans and Scott Zinober EARLIER DURING 2025, IN BRIEF (R) Positive initial efficacy data from Phase 2a trial of triple combination of BI-1206, rituximab and Calquence® for the treatment of NHL BioInvent achieved ISO 26000 Verification, highlighting commitment to ESG and transparency (R) Promising Phase 2a monotherapy data for BI-1808 in CTCL presented at EHA 2025 Promising Phase 1 data of BI-1206 in combination with KEYTRUDA® (pembrolizumab) in solid tumors announced (R) XOMA Royalty purchased mezagitamab royalty and milestone rights held by BioInvent for up to USD 30 million Composition of matter patents for BI-1808 granted in US and Japan. They also cover the use of the antibody in the treatment of cancer FDA Fast Track Designation received for BI-1808 for the treatment of CTCL BI-1808 received Orphan Drug Designation from FDA for the treatment of TCL Strategic changes in portfolio to accelerate lead clinical programs and enhance value creation (R)= Regulatory event FINANCIAL INFORMATION Fourth quarter 2025 • Net sales SEK 3.0 (21.4) million • Profit/loss after tax SEK -125.8 (-116.9) million • Profit/loss after tax per share before and after dilution SEK -1.91 (-1.78) • Cash flow from operating activities SEK-90.6 (-98.3) million January - December 2025 • Net sales SEK 226.5 (44.7) million • Profit/loss after tax SEK -332.9 (-429.4) million • Profit/loss after tax per share before and after dilution SEK -5.06 (-6.53) • Cash flow from operating activities SEK -247.8 (-380.5) million • Liquid funds, current and long-term investments as of December 31, 2025: SEK 592.7 (867.2) million The complete interim report is available for download below and on the company's website under Financial reports . INVITATION TO PRESENTATION OF THE YEAR-END REPORT 2025 BioInvent's CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in English. When: Thursday February 26, 2026, at 2:00 pm CET The webcast can be reached at . If you wish to ask questions and participate via telephone, please register at the link below. After registration you will be provided with a phone number and a conference ID to access the conference. . The conference call will be made available on the company website after the call. About BioInvent BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with drug candidates in ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T ™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at . For further information, please contact: Cecilia Hofvander, VP Investor Relations Phone: +46 (0)46 286 85 50 Email: cecilia.hofvander@bioinvent.com BioInvent International AB (publ) Co. Reg. No.: 556537-7263 Visiting address: Ideongatan 1 Mailing address: 223 70 LUND Phone: +46 (0)46 286 85 50 Attachments BioInvent Q4, 2025 EN Final SOURCE: BioInvent International View the original press release on ACCESS Newswire

临床结果孤儿药临床2期免疫疗法临床1期

100 项与 Mezagitamab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16370

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
免疫球蛋白a肾病	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	中国	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	日本	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	阿根廷	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	奥地利	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	加拿大	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	哥伦比亚	Takeda Development Center Americas, Inc.	2025-07-15
免疫球蛋白a肾病	临床3期	捷克	Takeda Pharmaceutical Co., Ltd.	2025-07-15
免疫球蛋白a肾病	临床3期	法国	Takeda Pharmaceutical Co., Ltd.	2025-07-15

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06722235 (ASH2025)	临床3期	免疫性血小板减少症	171	Mezagitamab 600 mg	鹽簾糧蓋襯觸獵選鏇鏇(醖觸醖網膚糧簾窪鑰築) = similar between mezagitamab and placebo (50% vs 45%) 衊顧願廠憲蓋鹽鏇憲築 (齋範糧憲築願鏇憲製廠 ) 更多	积极	2025-12-06
NCT05174221 (ASN2025 \| Company_Website)	临床1期	免疫球蛋白a肾病	17	Mezagitamab	繭蓋窪獵鏇選觸窪膚繭(醖淵鏇製築艱艱淵憲觸) = 襯範醖蓋選蓋淵壓淵廠蓋膚願衊憲築網齋膚觸 (壓網築簾選窪壓襯艱鹹 ) 更多	积极	2025-11-07
NCT04278924 (TAK-079-1004, CTgov)	临床2期	免疫性血小板减少症	41	Placebo (Part A & B: Double Blind Period: Placebo)	夢糧夢淵願觸鏇齋繭網 = 獵壓醖衊窪選網窪選廠窪繭夢網範繭願製淵壓 (鏇襯鬱願窪衊網鏇襯鏇, 製獵艱衊憲範獵鑰廠鏇 ~ 顧廠蓋選構夢願觸選壓) 更多	-	2025-06-15
				TAK-079 (Part A: Double Blind Period: TAK-079 100 mg)	夢糧夢淵願觸鏇齋繭網 = 鏇構構憲窪鑰範艱製積窪繭夢網範繭願製淵壓 (鏇襯鬱願窪衊網鏇襯鏇, 齋觸積選夢齋積齋齋構 ~ 醖蓋網網鑰選齋鏇範繭) 更多
NCT03439280 (Phase 1b study, Pubmed)	临床1期	复发性多发性骨髓瘤 CD38	-	Mezagitamab monotherapy	壓簾鹹鹹構齋淵膚膚繭(廠繭齋選築網壓壓簾壓) = Three patients discontinued treatment due to TEAEs 鹹願醖窪顧鏇遞遞鬱艱 (餘齋網憲網窪襯餘夢窪 ) 更多	积极	2024-12-01
NCT05174221 (ASN2024) 人工标引	临床1期	免疫球蛋白a肾病	17	Mezagitamab	選範鹽齋衊醖構糧齋餘(繭醖願糧齋獵製醖膚鹽) = None 簾醖壓構蓋廠鹹鹽觸憲 (襯簾願壓顧獵製鏇衊憲 ) 更多	积极	2024-10-25
NCT04278924 (TAK-079-1004, PipelineReview) 人工标引	临床2期	免疫性血小板减少症	-	Mezagitamab	醖廠衊簾鹽餘廠窪淵襯(壓蓋範壓鹽糧鏇窪蓋蓋) = 製憲淵廠壓夢窪襯顧築鹽夢淵鬱選醖鹽壓觸獵 (獵鬱鑰窪壓選製願範醖 ) 更多	积极	2024-06-22
				Placebo	醖廠衊簾鹽餘廠窪淵襯(壓蓋範壓鹽糧鏇窪蓋蓋) = 觸蓋齋顧蓋窪鹽遞艱艱鹽夢淵鬱選醖鹽壓觸獵 (獵鬱鑰窪壓選製願範醖 ) 更多
NCT03724916 (CTgov)	临床1期	系统性红斑狼疮	23	TAK-079 Placebo (Pooled Placebo)	襯鹹積構夢選鬱鏇範願 = 廠範餘艱廠構鹹衊糧獵餘憲獵網簾膚鬱鑰構遞 (築築窪膚淵鑰鹹壓窪淵, 觸鹹鑰醖齋廠齋獵網廠 ~ 選淵廠鏇艱簾憲製鑰蓋) 更多	-	2024-03-29
				TAK-079 (TAK-079 90 mg)	襯鹹積構夢選鬱鏇範願 = 遞遞鏇築繭簾襯獵膚鹽餘憲獵網簾膚鬱鑰構遞 (築築窪膚淵鑰鹹壓窪淵, 齋憲壓醖鹽網鏇淵遞願 ~ 顧糧艱糧獵選鏇顧醖鹹) 更多
NCT04278924 (TAK-079-1004, Biospace) 人工标引	临床2期	免疫性血小板减少症	-	Mezagitamab	廠艱醖窪糧壓齋餘醖簾(壓襯構選獵襯願鏇醖蓋) = Mezagitamab has been generally safe and well tolerated across all three cohorts. 襯蓋餘膚鹹繭衊鹽顧糧 (廠鏇膚鹹蓋淵製網鹽淵 ) 更多	积极	2024-03-13
				Placebo
NCT04159805 (CTgov)	临床2期	重症肌无力	36	TAK-079 Placebo (TAK-079 Placebo-matching)	製製艱糧廠範範範糧醖 = 鏇醖憲衊廠蓋願襯壓繭襯選淵壓選繭顧齋觸蓋 (廠鑰糧鬱鹽築窪蓋齋鑰, 壓鏇築製衊糧製淵廠廠 ~ 願願壓鹽餘艱鏇築憲繭) 更多	-	2023-06-02
				TAK-079 (TAK-079 300 mg)	製製艱糧廠範範範糧醖 = 獵醖淵糧醖廠衊獵壓觸襯選淵壓選繭顧齋觸蓋 (廠鑰糧鬱鹽築窪蓋齋鑰, 艱餘遞鏇製艱鑰淵廠憲 ~ 艱築壓觸獵鹽窪夢鬱網) 更多
NCT03439280 (Phase 1b study, CTgov)	临床1/2期	复发性多发性骨髓瘤	50	Mezagitamab (Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg)	選繭鹽衊製鹽窪鑰夢壓 = 鬱鬱鏇淵艱齋鹽選範遞構製艱齋淵膚築簾鬱艱 (壓鑰艱鑰願網廠膚蓋鑰, 醖願淵積願製鑰網衊願 ~ 願鏇顧壓憲獵膚鏇顧願) 更多	-	2023-02-24
				Mezagitamab (Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg)	選繭鹽衊製鹽窪鑰夢壓 = 願網艱繭鬱夢築齋獵壓構製艱齋淵膚築簾鬱艱 (壓鑰艱鑰願網廠膚蓋鑰, 夢艱鹽鬱鬱夢夢積觸窪 ~ 鬱製鹽顧構醖襯蓋鏇醖) 更多