A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy.

开始日期2022-08-09

申办/合作机构

Kite Pharma, Inc.

[+1]

NCT04155749 / Recruiting临床1期

Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up

Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.

开始日期2019-11-18

申办/合作机构

Kite Pharma, Inc.

[+1]

100 项与 Anti-BCMA CAR T-cell therapy(Arcellx, Inc.) 相关的临床结果

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100 项与 Anti-BCMA CAR T-cell therapy(Arcellx, Inc.) 相关的转化医学

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100 项与 Anti-BCMA CAR T-cell therapy(Arcellx, Inc.) 相关的专利（医药）

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项与 Anti-BCMA CAR T-cell therapy(Arcellx, Inc.) 相关的文献（医药）

2023-11-01·Blood Cancer Discovery

IVIg Use Associated with Ten-Fold Reduction of Serious Infections in Multiple Myeloma Patients Treated with Anti-BCMA Bispecific Antibodies

Article

作者: Lancman, Guido ; Cho, Hearn Jay ; Avery, Lisa ; Parsa, Kian ; Parekh, Samir S ; Thibaud, Santiago ; Chari, Ajai ; Sanchez, Larysa J ; Jagannath, Sundar ; Richard, Shambavi ; Kotlarz, Krzysztof ; Lurie, Alaina ; Lieberman-Cribbin, Alex ; Richter, Joshua ; Rossi, Adriana ; Rodriguez, Cesar

Abstract:

BCMA-targeted bispecific antibodies (BiAb) are efficacious in relapsed/refractory multiple myeloma; however, serious infections have emerged as important toxicities. In this retrospective study, we characterized all infections and their risk factors, and evaluated the impact of infection prophylaxis in patients treated with BCMA-targeted BiAbs. Among 37 patients, 15 (41%) experienced a grade 3–5 infection, with two infection-related deaths during deep remissions. Most (84%) infections occurred during disease remissions. The cumulative probability of grade 3–5 infection increased over time with no plateau. Among responders (n = 26), profound hypogammaglobulinemia occurred in 100% and continued throughout the entire duration of treatment. During periods when patients were receiving intravenous immunoglobulin (IVIg), the rate of grade 3–5 infections was 90% lower than during observation (incidence rate ratio, 0.10; 95% confidence interval, 0.01–0.80; P = 0.0307). No other risk factors for infection were identified. This study demonstrates that profound hypogammaglobulinemia is universal with BCMA-targeted BiAbs, with intravenous immunoglobulin potentially abrogating most of the infection risk.

Significance::

To the best of our knowledge, this is the first study to comprehensively analyze risk factors and mitigation strategies to prevent infections in myeloma patients receiving anti-BCMA bispecific antibodies. Profound and prolonged hypogammaglobulinemia was universal among responders, while immunoglobulin replacement was associated with 90% lower rates of grade 3–5 infections.See related commentary by Garfall and Stadtmauer, p. 427 .This article is featured in Selected Articles from This Issue, p. 419

2023-03-14·Blood Advances2区 · 医学

Phase 1 study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma

2区 · 医学

Article

作者: Shaw, Kit ; Raje, Noopur ; Heery, Christopher ; O'Donnell, Elizabeth K ; Daley, Heather ; Yee, Andrew J ; Avigan, David E ; Jakubowiak, Andrzej ; Bishop, Michael R ; Rosenblatt, Jacalyn ; Griffin, Faith ; Nikiforow, Sarah ; Logan, Emma ; Cook, Daniella ; Frigault, Matthew J ; Shen, Angela ; Cornwell, Christine ; Maus, Marcela V

Abstract:

Relapsed and refractory multiple myeloma (RRMM) is a plasma cell neoplasm defined by progressively refractory disease necessitating chronic and increasingly intensive therapy. Despite recent advances, limited treatment options exist for RRMM. This single-arm, open label phase 1 study aimed to evaluate the safety of novel B-cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T construct that leverages a completely synthetic antigen-binding domain (CART-ddBCMA), which was specifically engineered to reduce immunogenicity and improve CAR cell surface stability. Thirteen patients ≥18 years with RRMM who received at least 3 prior regimens of systemic therapy were enrolled in the study. Patients received a single dose of 100 × 106 CART-ddBCMA (DL1) or 300 × 106 CART-ddBCMA (DL2) following standard lymphodepleting chemotherapy. The primary endpoints of the study were to evaluate the incidence of treatment emergent adverse events, including dose-limiting toxicities, and establish a recommended phase 2 dose. Results showed that CART-ddBCMA was well tolerated and demonstrated a favorable toxicity profile. Only 1 case of grade ≥3 cytokine release syndrome and 1 case of immune effector cell–associated neurotoxicity were reported; both were at DL2 and were manageable with standard treatment. No atypical neurological toxicities and Parkinson disease-like movement disorders were observed. The maximum tolerated dose was not reached. All infused patients responded to CART-ddBCMA, and 9/12 (75%) patients achieved complete response/stringent complete response. Responses deepened over time, and at the time of last data-cut (median follow-up 56 weeks), 8/9 (89%) evaluable patients achieved minimal residual disease negativity. In conclusion, the findings demonstrate the safety of CART-ddBCMA cells and document durable responses to CART-ddBCMA in patients with RRMM. This trial was registered at www.clinicaltrials.gov as #NCT04155749.

2022-07-05·Molecular Cancer Therapeutics

Preclinical Efficacy of BCMA-Directed CAR T Cells Incorporating a Novel D Domain Antigen Recognition Domain

Article

作者: Richman, Laura K. ; Tice, David A. ; Zaritskaya, Liubov ; Witter, Alexandra R. ; Hilbert, David M. ; Buonato, Janine M. ; Edwards, Justin P. ; Gupta, Ankit ; LaFleur, David W.

Abstract:

Chimeric antigen receptor (CAR) T-cell therapies directed against B-cell maturation antigen (BCMA) have shown compelling clinical activity and manageable safety in subjects with relapsed and refractory multiple myeloma (RRMM). Prior reported CAR T cells have mostly used antibody fragments such as humanized or murine single-chain variable fragments or camelid heavy-chain antibody fragments as the antigen recognition motif. Herein, we describe the generation and preclinical evaluation of ddBCMA CAR, which uses a novel BCMA binding domain discovered from our D domain phage display libraries and incorporates a 4-1BB costimulatory motif and CD3-zeta T-cell activation domain. Preclinical in vitro studies of ddBCMA CAR T cells cocultured with BCMA-positive cell lines showed highly potent, dose-dependent measures of cytotoxicity, cytokine production, T-cell degranulation, and T-cell proliferation. In each assay, ddBCMA CAR performed as well as the BCMA-directed scFv-based C11D5.3 CAR. Furthermore, ddBCMA CAR T cells demonstrated in vivo tumor suppression in three disseminated BCMA-expressing tumor models in NSG-immunocompromised mice. On the basis of these promising preclinical data, CART-ddBCMA is being studied in a first-in-human phase I clinical study to assess the safety, pharmacokinetics, immunogenicity, efficacy, and duration of effect for patients with RRMM (NCT04155749).

项与 Anti-BCMA CAR T-cell therapy(Arcellx, Inc.) 相关的新闻（医药）

2024-04-04

·BioSpace

Arcellx to Participate in the 23rd Annual Needham Virtual Healthcare Conference

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Arcellx Inc., (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced that management will participate in a fireside chat at the 23rd Annual Needham Virtual Healthcare Conference on Wednesday, April 10, at 12:45 p.m. ET. A live webcast of this discussion will be accessible from Arcellx's website at in the Investors section. A replay of the webcast will be archived and available for 30 days following the event. About Arcellx, Inc. Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx's mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Arcellx's lead product candidate, anito-cel (formerly CART-ddBCMA), is being developed for the treatment of relapsed or refractory multiple myeloma (rrMM) in a Phase 2 pivotal trial. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration. Arcellx is also developing its dosable and controllable CAR T therapy, ARC-SparX, through two Phase 1 programs, ACLX-001 for rrMM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. For more information on Arcellx, please visit . Follow Arcellx on X (Twitter) at @arcellx and LinkedIn. Forward-looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including Arcellx's expectations regarding the timing and outcomes of clinical trials for its product candidates and the potential impact of its product candidates and platforms on patients and cell therapy. The forward-looking statements contained herein are based upon Arcellx's current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including risks that may be found in the section entitled “Part I, Item 1A (Risk Factors) in the Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on February 28, 2024, and other documents that Arcellx files from time to time with the SEC. These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

免疫疗法快速通道孤儿药细胞疗法临床2期

2024-03-20

·BioSpace

Arcellx to Participate at the H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Arcellx Inc., (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced that management will participate in a fireside chat at the H.C. Wainwright 2nd Annual Cell Therapy Virtual Conference on Tuesday, March 26, at 1:00 p.m. ET. A live webcast of this discussion will be accessible from Arcellx's website at in the Investors section. A replay of the webcast will be archived and available for 30 days following the event. About Arcellx, Inc. Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx's mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Arcellx's lead product candidate, anito-cel (formerly CART-ddBCMA), is being developed for the treatment of relapsed or refractory multiple myeloma (rrMM) in a Phase 2 pivotal trial. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration. Arcellx is also developing its dosable and controllable CAR T therapy, ARC-SparX, through two Phase 1 programs, ACLX-001 for rrMM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. For more information on Arcellx, please visit . Follow Arcellx on X (Twitter) at @arcellx and LinkedIn. Forward-looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including Arcellx's expectations regarding the timing and outcomes of clinical trials for its product candidates and the potential impact of its product candidates and platforms on patients and cell therapy. The forward-looking statements contained herein are based upon Arcellx's current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including risks that may be found in the section entitled “Part I, Item 1A (Risk Factors) in the Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on February 28, 2024, and other documents that Arcellx files from time to time with the SEC. These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

免疫疗法细胞疗法孤儿药快速通道临床2期

2024-02-29

·PRNewswire

Arcellx to Participate at the TD Cowen 44th Annual Health Care Conference

REDWOOD CITY, Calif., Feb. 29, 2024 /PRNewswire/ -- Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced that management will participate in a fireside chat at the TD Cowen 44th Annual Health Care Conference on Wednesday, March 6, at 2:50 p.m. ET. A live webcast of this discussion will be accessible from Arcellx's website at in the Investors section. A replay of the webcast will be archived and available for 30 days following the event. About Arcellx, Inc. Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx's mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Arcellx's lead product candidate, anito-cel (formerly CART-ddBCMA), is being developed for the treatment of relapsed or refractory multiple myeloma (rrMM) in a Phase 2 pivotal trial. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration. Arcellx is also developing its dosable and controllable CAR T therapy, ARC-SparX, through two Phase 1 programs, ACLX-001 for rrMM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. For more information on Arcellx, please visit . Follow Arcellx on X (Twitter) at @arcellx and LinkedIn. Forward-looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including Arcellx's expectations regarding the timing and outcomes of clinical trials for its product candidates and the potential impact of its product candidates and platforms on patients and cell therapy. The forward-looking statements contained herein are based upon Arcellx's current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including risks that may be found in the section entitled "Part I, Item 1A (Risk Factors) in the Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on February 28, 2024, and other documents that Arcellx files from time to time with the SEC. These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Investors: Myesha Lacy [email protected] 510-418-2412 Media: Andrea Cohen Sam Brown Inc. [email protected] 917-209-7163 SOURCE Arcellx, Inc.

免疫疗法孤儿药快速通道细胞疗法临床2期

100 项与 Anti-BCMA CAR T-cell therapy(Arcellx, Inc.) 相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
复发性多发性骨髓瘤	临床2期	美国更多	Kite Pharma, Inc. 更多
浆细胞骨髓瘤难治	临床2期	美国更多	Kite Pharma, Inc. 更多
多发性骨髓瘤	无进展	美国更多	Arcellx, Inc. 更多

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分期

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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


ASH2023 人工标引	临床1期	多发性骨髓瘤末线	38	CART-ddBCMA	鏇獵顧構鹹醖簾顧壓願(鹽鑰廠鏇餘願繭構鹹醖) = 網構廠築願鹽鏇範鑰構衊淵鑰憲衊鏇築鑰醖顧 (艱衊淵構窪範鏇齋夢憲 ) 更多	积极	2023-12-11
PRNewswire 人工标引	临床1期	多发性骨髓瘤	38	CART-ddBCMA	壓餘繭糧淵淵鹽夢繭築(夢顧膚艱窪廠獵蓋鑰繭) = 窪鬱糧築夢鏇簾餘觸餘餘餘餘壓鹽餘獵衊鬱簾 (鹹鹹鑰簾構醖憲餘鏇廠 ) 更多	积极	2023-12-08
ASH2022 人工标引	临床1期	复发性多发性骨髓瘤 \| 浆细胞骨髓瘤难治	31	Fludarabine 30 mg/m2/day+Cyclophosphamide 300 mg/m2/day+CART-Ddbcma	製蓋窪餘壓廠積製膚鑰(築廠積鹹鬱齋構觸築構) = 衊鹽簾廠艱醖製積襯膚淵觸網蓋淵顧鏇鬱齋艱 (顧繭醖鏇夢構鑰構築願 ) 更多	积极	2022-11-15
NCT04155749 (ARC-101, ESMO2022) 人工标引	临床1期	多发性骨髓瘤末线	25	CART-ddBCMA 100x10^6/300x10^6 CAR+T cells	鹹膚獵淵獵選繭遞範遞(顧廠壓窪膚糧醖鏇遞鹽) = 築蓋網夢遞鹽襯膚蓋膚築選衊鏇齋艱醖餘醖鹽 (鏇壓鹹廠積範壓廠壓鬱 ) 更多	积极	2022-09-10
NCT04155749 (ARC-101, ESMO2022) 人工标引	临床1期	多发性骨髓瘤末线	25	CART-ddBCMA 100x10^6/300x10^6 CAR+T cells (DL1)	鹹膚獵淵獵選繭遞範遞(顧廠壓窪膚糧醖鏇遞鹽) = 選獵夢構觸窪鏇憲窪壓築選衊鏇齋艱醖餘醖鹽 (鏇壓鹹廠積範壓廠壓鬱 ) 更多	积极	2022-09-10
IMS2022	临床1期	复发性多发性骨髓瘤	33	CART-ddBCMA	構獵製繭繭蓋齋鹽衊蓋(餘簾憲醖鑰鹹齋繭築醖) = 鏇餘鬱憲艱襯衊積衊衊醖壓網襯觸襯夢獵夢鹽 (遞獵構簾鑰壓鹹鏇獵鏇 ) 更多	积极	2022-08-25
NCT04155749 (ARC-101, Corporate Publications) 人工标引	临床1期	多发性骨髓瘤	31	CART-DdBCMA	齋鏇鏇蓋糧夢構顧製糧(鹹艱顧遞構觸構網窪顧) = 膚蓋膚膚衊餘膚餘鬱簾鑰簾窪窪願築觸鏇醖製 (齋鑰餘鹽廠遞淵鏇鹽襯 ) 更多	积极	2022-06-03
NCT04155749 (Pubmed \| Blood Adv)	临床1期	复发性多发性骨髓瘤	-	CART-ddBCMA (DL2)	蓋觸壓願齋壓衊艱製淵(艱憲廠衊壓選鑰淵壓窪) = 夢夢築壓積築壓襯餘淵願淵鏇糧糧淵襯製衊繭 (鹽繭構觸鹹夢積範餘獵 )	积极	2022-04-25
NCT04155749 (ARC-101, ASCO2021)	临床1期	复发性多发性骨髓瘤	10	CART-ddBCMA	積選簾築壓襯艱鏇遞艱(糧壓衊鑰構蓋構繭餘顧) = 餘淵廠憲淵鏇膚夢積蓋範窪鹹鹹積鹹範膚窪鹽 (壓顧觸構鏇鑰繭齋顧齋, 61 ~ 87) 更多	-	2021-05-28
NCT04155749 (ASH2020) 人工标引	临床1期	复发性多发性骨髓瘤末线	4	fludarabine+cyclophosphamide+CART-ddBCMA	鏇醖鏇糧積獵積糧糧廠(襯鹹築衊窪淵網遞製淵) = Three subjects developed Grade 2 cytokine release syndrome (CRS) and 1 subject developed Grade 2 ICANS. 廠構積壓夢獵淵顧壓鹹 (膚糧簾範醖窪網顧鏇衊 )	积极	2020-11-05