Bendamustine Hydrochloride

SAN DIEGO, July 06, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune disease, today announced that preliminary clinical data from the Company’s off-the-shelf CAR T-cell product candidate, FT819, will be presented at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting, being held at the Palais des congrès de Montréal in Montréal, Canada on July 8 - 11, 2026. The Company is participating in the Clinical Trials Update oral session and will present on the Systemic Sclerosis (SSc) arm of its ongoing Phase 1 basket trial evaluating FT819 in various autoimmune diseases. The cohort is enrolling a treatment-refractory patient population, with eligibility requiring both prior treatment failure and ongoing active disease. The upper limit on disease duration for study entry was broadened to include patients with up to 15 years of disease duration, an intentional design choice to increase inclusivity while evaluating the therapy across a broader spectrum of patients. Highlights of the presentation include data from the first four SSc patients treated as of the June 12, 2026 data cutoff. Three of the four patients were treated under Regimen A with less-intensive conditioning chemotherapy (cyclophosphamide or bendamustine alone) and one patient was treated under Regimen B with no conditioning chemotherapy. All participants demonstrated a Revised Composite Response Index in Systemic Sclerosis (rCRISS)25 or higher with meaningful mean improvement in the Modified Rodnan Skin Score (mRSS) at 3 months post treatment. The treatment was well tolerated with no Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Graft versus Host Disease (GvHD), hypogammaglobulinemia, or deaths reported in SSc participants on study. These data points reinforce the well-tolerated safety pro FT819 and demonstrate encouraging clinical activity with the use of less-intensive or no conditioning chemotherapy, supporting its continued advancement as an off-the-shelf, on-demand, outpatient CAR T-cell therapy for SSc, an autoimmune disease with significant unmet need. FT819 is also being evaluated in Systemic Lupus Erythematosus (SLE) as part of the ongoing basket trial, with a Phase 2 potentially registrational trial planned in Lupus Nephritis. Late-breaking Abstract Oral Presentation: Title: Emerging Data with FT819: Favorable Tolerability and Clinical Activity in Systemic Sclerosis Using Off-the-Shelf IPSC-Derived Anti CD19 CAR T-Cells Without Fludarabine Session : Clinical Trial Updates Presentation Date / Time : Thursday, 9 July 2026, 9:45 AM EDT About FT819 FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product candidate engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant number: CLIN2-16303) About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the Company’s plans to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, and the Company’s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities, including its expectations relating to alignment with regulatory authorities on potential registrational pathways for FT819. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and risks relating to regulatory interactions and the outcome of such interactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Contact: Ryan Douglas Fate Therapeutics, Inc. IR@fatetherapeutics.com

从本号去年梳理B细胞清除机制的药物（参见【药海听涛】CAR-T和TCE决战紫禁之巅：B细胞清除药物临床数据全景图）已半年有余，整个赛道非但没有退热，反而又持续升温，尤其以LLY连续撒币重注Kelonia和Orna、GILD和UCB又后知后觉收购TCE资产最令人咋舌，显得笔者此前的谨慎颇不合时宜。 那么问题来了，无论是各种CAR-T、还是TCE，让这些MNC慷慨解囊的是什么样的新支持证据呢？在ASCO、ASGCT、EULAR扎堆的6月之后，我们再来更新一遍这些B细胞清除机制药物的临床数据，来尝试理解大药企的信心来源。 注：1. 目前B细胞清除机制的这些药物几乎全都在早期临床、甚至IIT，跨试验对比数据至多只有示意性意义；2. B细胞清除药物的适应症选择较多，包括血液瘤和多种自身免疫疾病，本文在多数管线都选择交集最多的SLE适应症、以利对比分析，只在invivo CAR-T囊括了部分血液瘤临床结果、重在展示PK/PD；3. 本次重点更新近半年的临床结果，从去年至今未披露新结果的可参见前文。 （完整分析PPT和全部文献来源当然还是推荐关注知识星球） 1 自体CAR-T 自体CAR-T的进展依然是在跟随George Schett大神的步伐，至少单靶点很难重现那样完美的有效性和安全性。 当然作为中国企业的传统艺能，单靶到了、双靶还会远吗？ 1.1 Cabaletta：CABA-201（CD19 CAR-T） Cabaletta在CAR-T治疗自免疾病上布局动作最快最全，目前Myositis、SLE、SSc、gMG、MS、PV等一系列适应症都在齐头并进。 CABA-201在多个适应症上都有初步的PK/PD验证，CAR-T细胞数量峰值约1E2 cells/μL，外周血B细胞在10-50天内基本清除、甚至在2例不清淋的患者中也有1例有较好的清除。 在清淋组随访达一年的8例SLE患者中，有6例实现DORIS缓解、特别是其中狼疮肾炎患者全部DORIS缓解，应该说在Schett以外算是相当过硬的有效性了。 安全性方面，CRS仅有1-2级，但有4级ICANS和4级全血细胞减少各1例需后续观望。 1.2 Novartis：YTB-323（CD19 CAR-T） 作为CAR-T技术在血液瘤领域的先驱者，Novartis自不甘于人后。 YTB-323的CAR+ T细胞数量峰值约50 cells/μL（已经比Schett和CABA-201略偏低了），外周血B细胞清除的中位时间也在50天左右。 虽未明确披露，不过从SLEDAI-2K评分来看，SLE患者在半年内绝大多数都能实现DORIS缓解、而LN患者则不尽如人意。 安全性方面，CRS也只有1-2级，ICANS只有1级，但血液毒性高发、绝大多数都在3级以上。 1.3 亘喜/AZ：GC-012F（CD19xBCMA FasT CAR-T） 亘喜是最早被MNC整体收购的细胞治疗公司（甚至一度也是整个中国Biotech被收购的标杆），不过AZ买完之后在自免的动作也略有点磨蹭了，从去年EULAR以后就鲜有更新读出（当然比隔壁西比曼惨遭退货好多了）。 GC-012F的PK/PD可以说相当惊艳，Cmax达到4E4 copies/μgDNA，外周B细胞清除中位时间达到56天。 从药效来看，9个月内9/15例患者达到DORIS缓解，略有泯然众人之感。 安全性方面，有2例3级CRS和1例2级ICANS值得关注，同样血液毒性高发。 2 异体CAR-T 在invivo CAR-T和TCE两大小甜甜的衬托下，UCAR-T一副牛夫人的形象，但细品起来，以北恒为首的中国UCAR-T玩家数据还挺扎实。 2.1 北恒：CTA-313（CD19xBCMA UCAR-T） 北恒从去年ACR横空出世，今年ASGCT公布了更多例数的数据（从14例增加到28例），不过似乎水平略有滑坡。 CTA-313的CAR基因峰值约为1E5 copies/μgDNA，外周B细胞清除维持了约30天，且重建后naive细胞占绝大多数。 不过药效却变得略显平庸，随访9个月后也就50%患者实现DORIS缓解，这其中非肾炎患者很明显拉胯了。 2.2 Fate：FT-819（iPSC来源CD19 UCAR-T） 邪修版本的Fate在尝试不清淋的路子上碰了一鼻子灰，回头还想在弱清淋、甚至优选清淋方案上做文章，然并卵。 不清淋组的B细胞清除基本都很难干净，即便是弱清淋组，环磷酰胺也清不干净，苯达莫司汀只能维持1个月。 只有苯达莫司汀清淋有1例实现DORIS缓解，而环磷酰胺清淋则连SLEDAI-2K评分都压不住。 3 体内CAR-T 经过近一年的IIT竞速，invivo CAR-T领跑者们纷纷拿出初步的临床数据，坦率说是有可圈可点之处，但多数都还是血液瘤数据，解释不了何以能值那么多钱…… 先是LNP路线，虽然转染效率在线，但好像B细胞清除时间普遍偏短，最终是否能通过重复给药实现长期B细胞清除、以至于转化成对自免疾病的药效，尚在未定之期。 再看LVV路线，虽然转染明显更持续，但也存在起效偏慢的迹象，总体药效也并无甚神奇之处，而且各种SAE频出，对自免疾病上的应用明显并不友好。 3.1 微韬：GT-801（tLNP CD19 invivo CAR-T） 且不谈药效什么的，微韬是目前唯一能看到每周一次给药的invivo CAR-T（相比起来每2-3天一次给药实在有点不能忍），而且也是唯一尝试两个月后re-dosing的玩家，看上去备受顾虑的免疫原性还可接受，考虑到LNP转染难以持续的先天劣势，re-dosing应该是后续应用的必由之路。 GT-801的CAR转让效率峰值约80%，外周B细胞清除至少能维持8周。现有4例B细胞淋巴瘤患者也是3例CR、1例PR，后续自免疾病的结果还挺值得期待。 安全性方面，出现了1例3级CRS（虽然号称是因为没有预处理给地塞米松），以及血液毒性同样高发。 3.2 虹信生物：HN-2301（tLNP CD19 invivo CAR-T） 去年就吐槽过虹信那篇没活硬整的NEJM，现在想想不仅转染效率偏低、B细胞清除不干净、没有DORIS缓解，甚至连PK都太短，以至于需要每2天一次连打5次，这对于SLE患者实在太不友好。 等了半年似乎也没公开更多有力数据，只在今年ASGCT看到骨髓和淋巴结等组织深处的B细胞清除，话说这不还是在没有DORIS缓解那6例里么…… 3.3 威斯津：WGb-0301（tLNP CD19 invivo CAR-T） 作为mRNA疫苗时代的遗珠，转身自救的动作算是比较快，在ASGCT上拿出了IIT上4例NHL结果，不过这每3天一次的给药间隔也偏短了。 PK/PD看起来说得过去，4次给药后CAR+ T细胞峰值能达到约80%，在这期间B细胞清除还算干净，不过似乎10天一过就开始抬头了。 这4例的药效属实平庸，仅1例CR和1例PR，毕竟其他invivo CAR-T竞品动辄ORR都是100%。 安全性倒是比较干净，CRS只有1级，没有ICANS，不过3级血液毒性还是无法避免。 3.4 星锐：STR-P004（tLNP CD19 invivo CAR-T） 星锐是另一家起步较早的LNP路线玩家，在ASCO上发表了3例自免结果，转染效率57%似乎不算太惊艳，外周B细胞清除也只说在3-12天内。药效只能说有、但不多，基本都只看到在给药后短时间的疾病改善，2例ITP患者的血小板有一定恢复、但很快又降低，其中那1例SLE-ITP还进展到蛋白尿，另外那1例LN患者的SLEDAI-2K评分在1个月内降低、但在1.5个月又反弹。安全性不错，CRS只有1级，没有ICANS。 3.5 Kelonia：KLN-1010（LVV BCMA invivo CAR-T） LVV路线、乃至于整个invivo CAR-T最当红的炸子鸡，莫过于被LLY以首付款$3.25b和总金额$7b收购的Kelonia，在ASCO上披露的这18例MM数据当得起字面意义上的“字字珠玑”。 从PK/PD来看，KLN-1010可以说把LVV路线转染持久的优势发挥了出来，虽然CAR+ T细胞峰值也就35-53%、CAR基因峰值也就7-11E4，不过能在给药后6个月都维持在较高的水平，这使LNP路线难以望其项背。 药效方面，短期毫无优势、前4个月CR寥寥无几，而正如PK所显示后劲不错，在随访超过4个月的6例患者中4例sCR和2例VGPR。 安全性也还可接受，CRS只有1-2级，有1例3级ICANS和1例3级肺炎感染值得关注，诚然LVV路线的顾虑还是在长期，目前还需要观望。 3.6 传奇：LB-2501（LVV CD19/CD20 invivo CAR-T） 作为自体CAR-T时代的legend，传奇在invivo升级的第一步就果断迈向双靶。这次EHA公布了中低剂量的12例NHL结果，值得一提的是其中包括了CAR-T和TCE经治的患者。 从PK来看，低剂量（1-5E8 TU）确实完全不灵，中剂量（0.8-1.5E9 TU）还不错，CAR基因峰值达到1E5 copies/μgDNA，并且直到120天还能保持在1E4以上。 药效同样也只有中剂量能看，6例中有5例CR，而且从给药后1个月起就开始看到药效、这比KLN-1010快多了。 安全性方面，CRS只有1-2级，没有ICANS，除了血液毒性也没有其他≥G3 AE。 3.7 EsoBiotec：ESO-T01（LVV BCMA invivo CAR-T） Eso是最早火起来的invivo CAR-T公司之一，去年凭借一两例中国IIT数据被AZ收入囊中。或许也是意识到去年Lancet上的结果争议颇多，今年又在Nat Med发表了一波更新的数据（从基线判断完全是新一波患者）。 从PK来看，峰值看着尚可，CAR基因能达到约1E5 copies/μgDNA、CAR+ T细胞能达到约1E3 cells/μL，但大约只能维持1个月、明显短于Kelonia和传奇，这就解释了B细胞清除也只能维持10-30天。 小样本的药效反倒相当不错，5例中有3例在2个月后sCR、且一直持续，至少起效比Kelonia快多了。 安全性跟去年公布的相比，没那么瘆人了，但也挺棘手，3例3级以上CRS和1例ICANS，外加血液毒性。 4 TCE 2024年一众顶级MNC们在TCE上豪掷近百亿美元，当时还觉得好像已经“应买尽买”，孰料到2026年还有GILD和UCB这些二线大药企继续撒币，似乎已经不是FOMO可以解释。然而问题在于，以同润为首的那批TCE管线在被收购后鲜有进展，尤其是在自免疾病上甚至连临床启动都磨蹭很久，两年时间好不容易等到Cullinan的首批临床数据好像也不像是能技压群雄的架势，总感觉自己的常识判断与MNC的真金白银完全是在相向而行、互道xx…… 4.1 Cullinan：CLN-978（CD19xCD3双抗） 既然Cullinan是这一批TCE的领跑者，那我们自然以它作为评价整个modality的重要锚点。从CLN-978的一期临床来看，priming-dose依然必要，喜人的是已经可以做成皮下制剂。 在SAD部分（priming-dose之后在目标剂量只打一针），只有50%患者能实现比较深度的外周B细胞清除，清除持续时间也就1-4周。虽然还没有看到多剂量的结果，至少相比于前面各种CAR-T而言，这不能说有什么优势。 至于药效，14例SLE患者中仅5例DORIS缓解，且缓解持续时间存疑、缓解多见于低剂量组，这也不太能被解读为多么优异的有效性结果吧。 安全性方面，比早年Blincyto之流肯定要好得多了，不过也依然出现了1例3级以上CRS，没有ICANS。 4.2 天劢源和：A-319（CD19xCD3双抗） 天劢源和其实是TCE尝试应用于自免的元老，早在2024年ACR就首次公布了IIT数据，不过至今也没有太多的注册临床开发进展，今年EULAR只是更新了更多几例数据，而且看到这个每周1/3/5静脉输注6小时的给药方式，就觉得不太科学。 对外周B细胞的清除，低剂量完全清不干净，中高剂量在停药后也迅速反弹。 药效也只能说一般，给药12个月后，10例患者中有5例实现DORIS缓解。 4.3 惠和生物：CC-312（CD19xCD28xCD3三抗） 惠和是在自免TCE上引入CD28第二信号的先行者，去年的前几例IIT数据相当不怎么样，今年AACR更新了更多剂量爬坡的数据。每周两次静脉输注1-2小时，也就比天劢源和那个给药方式稍好一点吧。 外周B细胞清除依然并不持久，停药后1个月迅速反弹，可喜的是在中高剂量组能看到几例骨髓深度清除的证据。 于是药效也就非常有限，DORIS缓解寥寥无几。 安全性方面，CRS只有1级，没有ICANS，但有1例4级中性粒细胞减少值得关注。 5 其他 对于那些超出三界外、不在五行中的玩家，看起来要么没啥用、要么疑点多，暂时应该很难在自免疾病上成为主流。 5.1 ROG：Obinutuzumab（CD20单抗） 其实这个其他部分最重要的就是这个CD20单抗，且更重要的意义，就是拿这个单抗作为标准，来看看各路双/多抗及CAR-T、TCE等复杂操作到底有多大边际获益。 首先从外周B细胞清除上就给了大家当头棒喝，只需要每半年两针，就可以一直保持92-99%的清除水平，相比起来invivo CAR-T和TCE们绞尽脑汁延长清除时间显得费力不讨好。 然后是SLE病情改善，35%患者实现DORIS缓解、77%患者SRI-4响应，虽说不算多么惊人、跟Schett肯定没法比，但似乎真的能在大样本碾压这个水平的也寥寥无几。 诚然跨临床有很多不可比之处，Obinutuzumab这个药效建立在联用方案的基础上，问题是如果简单的CD20单抗+免疫抑制剂就能一定程度上解决问题，顶着那么大风险和成本去做TCE、乃至invivo CAR-T的必要性是不是就被大幅削弱了呢？ 5.2 宜明昂科：IMM-0306（CD47xCD20双抗） 作为宜明昂科转型的期望，IMM-0306去年的药效数据实在一言难尽，于是今年又往上爬了两个剂量，在EULAR上公布了最新数据。 从B细胞清除来看，至少在8周内清除得相当干净，而且重建后naive细胞为主、不过其实是有一些记忆细胞残留的。 然而一看药效还是很灾难，32例患者中DORIS缓解凤毛麟角，SRI-4在中高剂量也就70-80%。 5.3 JNJ：Nipocalimab（FcRn单抗） FcRn单抗在获批了gMG适应症之后，JNJ在SLE上也开了228例加安慰剂对照的二期临床。然而有效性实在惨淡，52周的SRI-4也就在50%多、离DORIS缓解更遥远，而且双链DNA抗体的降幅只有20-30%多，这跟前面那些疗法完全不在一个档次。 5.4 NVS：Ianalumab（BAFF-R单抗） NVS的BAFF-R单抗同样是干燥症获批之后，在SLE上做了大规模二期临床的尝试。这有效性也只比上面Nipocalimab好一点而已，52周DORIS缓解率仅9/33，双链DNA抗体只降低50%多。 5.5 恒瑞：SHR-2173（IFNAR-1/TACI融合蛋白） 看到这样的SLEDAI-2K曲线，基本上就放弃对药效的指望了，基线低还没多少降幅，“各访视时间点总体”的SRI-4只有69%，就别提DORIS缓解了。 看完这一堆形形色色的临床结果，我们不妨回头捋一下逻辑线，因为Schett证明了自体CAR-T能够有效清除致病B细胞、并且对自免疾病有突出的治疗效果，所以基于类似的B细胞清除机制的药物开始大火。 然而，我们观察到后续其他自体CAR-T并不能复现Schett那样的临床结果，至于由此延伸出的invivo CAR-T和TCE在早期临床中的药效更是难忘项背，更有甚者发现一通操作猛如虎可能也不见得就比单抗带来多大的边际获益。在如此的确定性下，MNC们就豪掷数百亿美元，总让人感到一种隐隐的不安。 多年以后，面对董事会，戴维·里克斯将会回想起医学团队带他去见识Schett临床数据的那个遥远的下午。