NCT05722418招募中1 期
A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (CaMMouflage Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 16
- 主要终点
- (Part B) Overall Response Rate (ORR)
研究概览
简要总结
This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
- •Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination.
- •Eastern Cooperative Oncology Group performance status grade of 0 or
- •Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
排除标准
- •Prior treatment with CAR-T cell therapy directed at any target.
- •Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
- •Allogeneic stem cell transplant within 6 months before lymphodepletion.
- •Known active or prior history of CNS involvement.
- •Stroke or seizure within 6 months of signing ICF.
- •Seropositive for or history of human immunodeficiency virus.
- •Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
- •Hepatitis B infection.
- •Hepatitis C infection.
- •Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
研究组 & 干预措施
CB-011
Experimental
- Part A Escalation with CB-011 in ascending doses using a traditional 3+3 design.
- Part B Expansion. Up to 30 participants will be enrolled to receive CB-011 at the RDE/MTD and/or RP2D determined in Plan A
干预措施: CB-011 (Biological)
结局指标
主要结局
(Part B) Overall Response Rate (ORR)
时间窗: 12 Months
The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.
(Part A) Number of patients with dose limiting toxicities (DLT)
时间窗: 28 days
Number of patients with DLTs during the 28 days following the first administration of CB-011.
次要结局
未报告次要终点
研究者
研究点 (16)
Loading locations...
相似试验
撤回
1 期
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)LupusLupus NephritisSystemic Lupus ErythematosusLupus ErythematosusNCT06752876Caribou Biosciences, Inc.20
招募中
1 期
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)Lymphoma, Non-HodgkinRelapsed Non Hodgkin LymphomaRefractory B-Cell Non-Hodgkin LymphomaNon Hodgkin LymphomaB Cell LymphomaB Cell Non-Hodgkin's LymphomaLymphomaNCT04637763Caribou Biosciences, Inc.72
终止
1 期
Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant MelanomaMelanomaNCT03878719Pfizer1
进行中（未招募）
1 期
Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered iv in Patients With PDACMetastatic Pancreatic CancerNCT06059001Peptomyc S.L.26
撤回
1 期
Combination Therapy of SyB C-1101 and Azacytidine in Patients With Myelodysplastic SyndromeMyelodysplastic SyndromeNCT02783547SymBio Pharmaceuticals