NCT05169489终止1 期
A Phase 1/2 Study of bbT369, a Dual Targeting CAR T Cell Drug Product With a Gene Edit, in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Phase 1: Incidence of safety events including: adverse events (AEs), adverse events of special interest (AESIs), and dose limiting toxicities (DLTs)
研究概览
简要总结
This non-randomized, open label, multi-site, first-in-human, Phase 1/2 study CRC-403 will evaluate the safety and efficacy of bbT369 in subjects with relapsed and/or refractory B cell non-Hodgkin's lymphoma (NHL).
A long-term follow-up (LTF-01 [NCT06798298]) is planned, in which subjects who received bbT369 will be followed for up to 15 years after drug product infusion to evaluate for safety and continued efficacy.
详细描述
Former Sponsor 2seventy bio
The trial was intended to be a Phase 1/2 trial, but no participants were enrolled in Phase 2, consequently the study was terminated in Phase 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age at the time of signing informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Diagnosis of B-cell NHL according to WHO 2017 classification or WHO 2016 classification where applicable:
- •DLBCL (germinal center B cell [GCB] or activated B cell [ABC] type or not otherwise specified [NOS])
- •HGBCL (with MYC and BCL2 and/or BCL6 rearrangements or NOS)
- •DLBCL transformed from FL
- •Participants must have relapsed or refractory (r/r) B cell NHL after autologous stem cell transplant (ASCT) or at least 2 prior lines of therapy including an anti-CD20 monoclonal antibody and an anthracycline containing chemotherapy regimen. Note: participants with DLBCL transformed from FL must have r/r disease after ASCT or at least 2 prior therapies following transformation irrespective of therapeutic agents.
- •At least 1 FDG-avid lesion per Lugano Classification criteria at time of enrollment.
排除标准
- •Treatment with any investigational cellular therapy prior to enrollment. Treatment with an approved anti-CD19 CAR T cell therapy in an investigational setting may be permitted after discussion with and approval of the Sponsor.
- •Progression within 6 weeks of prior anti-CD19 CAR T cell therapy.
- •Residual toxicities or end-organ damage to vital organs from prior therapy that could put a subject at undue risk based on Investigator's assessment. Toxicities related to prior cytokine release syndrome (CRS) or neurotoxicity must be resolved.
- •If a subject has received prior anti-CD19 CAR T therapy, development of ≥ Grade 3 CAR T related CRS or ≥ Grade 3 neurotoxicity that in the opinion of the Investigator would cause unacceptable risk of toxicity to the subject upon treatment with bbT
- •Primary central nervous system (CNS) lymphoma or a history or presence of clinically relevant CNS pathology.
- •Active autoimmune disease requiring systemic immunosuppressive and/or cytotoxic therapy within the past two years.
- •Treatment with any prior anti-CD79a therapy.
- •Previous history of an allogeneic bone marrow transplantation. Autologous stem cell transplantation (ASCT) is permitted.
研究组 & 干预措施
bbT369 Experimental Arm
Experimental
Open label, single arm treatment with bbT369
干预措施: bbT369 (Biological)
结局指标
主要结局
Phase 1: Incidence of safety events including: adverse events (AEs), adverse events of special interest (AESIs), and dose limiting toxicities (DLTs)
时间窗: Day 1 through Month 24
次要结局
- Phase 1: Rates of disease-specific response criteria including complete response rate(CRR), partial response rate(PRR), stable disease rate(SDR), and progressive disease rate(PDR) according to the Lugano 2014 response criteria as assessed by Investigator(Day 1 through Month 24)
- Phase 1: Time to complete response (TCR)(Day 1 through Month 24)
- Phase 1: Overall Response Rate (ORR) according to the Lugano 2014 response criteria as assessed by Investigator(Day 1 through Month 24)
- Phase 1: Time to response (TTR)(Day 1 through Month 24)
- Phase 1: Time to next treatment for B Cell NHL (TTNT)(Day 1 through Month 24)
研究者
研究点 (4)
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