A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

PeproMene Bio, Inc.1 个研究点分布在 1 个国家目标入组 24 人2021年5月18日

适应症Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

干预措施BAFFR-CAR T cells

概览

阶段: 1 期
干预措施: BAFFR-CAR T cells
疾病 / 适应症: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
发起方: PeproMene Bio, Inc.
入组人数: 24
试验地点: 1
主要终点: Incidence of adverse events
状态: 进行中（未招募）
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验相关资讯

概览

简要总结

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

详细描述

This phase I trial evaluates the side effects and best dose of BAFFR-CAR T cells in treating patients with B-cell Acute Lymphoblastic Leukemia that has come back (recurrent) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize BAFFR, a protein on the surface of cancer cells. These BAFFR-specific T cells may help the body's immune system identify and kill BAFFR+ cancer cells.

注册库

clinicaltrials.gov

开始日期

2021年5月18日

结束日期

2027年11月18日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

PeproMene Bio, Inc.

责任方

Sponsor

入排标准

入选标准

•Documented informed consent of the participant and/or legally authorized representative.
•Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study PI approval.
•Age ≥ 18 years.
•Life expectancy ≥ 16 weeks.
•Histologically confirmed B-ALL or B-cell lymphoblastic lymphoma
•Relapsed/refractory disease after failure of ≥ 2 prior lines of therapy.
•Evidence of active BAFF-R expression at the time of enrollment.
•Recovered to ≤ Grade 1 from the acute toxic effects (except alopecia) of prior anti-cancer therapy.
•No known contraindications to leukapheresis, steroids or tocilizumab.
•Ineligible for or failed prior CD19-targeted immunotherapy (e.g., blinatumomab or CD19-CAR T cells).

排除标准

•Autologous/allogeneic stem cell transplant within 100 days at the time of enrollment.
•Immunosuppressant medications within 1 months prior to protocol enrollment.
•Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone ≤ 7.5 mg /day or equivalent) is allowed
•Auto-immune disease or active GVHD within 4 months prior to protocol enrollment requiring systemic immunosuppressant therapy.
•Class III/IV cardiovascular disability according to the New York Heart Association (NYHA) Classification.
•Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within 2 weeks of enrollment.
•Any abnormal liver enzyme levels (as defined ≥ULN in ALT, AST, Bilirubin and Alkaline Phosphatase levels) at time of enrollment
•. Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
•Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia.

研究组 & 干预措施

BAFFR-CAR T cells

B-cell activating factor receptor-Chimeric antigen receptor T cells

干预措施: BAFFR-CAR T cells

结局指标

主要结局

Incidence of adverse events

时间窗: Up to 1 year post treatment

Toxicity will be graded per Common Terminology Criteria for Adverse Events version 5.0, Cytokine Release Syndrome (CRS) and neurotoxicity which use the American Society for Transplantation and Cellular Therapy Consensus Criteria (ASTCT) and Graft versus Host Disease (GVHD) criteria. Toxicities will be followed from the start of lymphodepletion until the end of the study.

次要结局

Minimal residual disease (MRD)(Up to 1 year post treatment)
B cell frequency(Up to 1 year post treatment)
Disease response(Up to 1 year post treatment)
Progression-free survival (PFS)(From T cell infusion to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 15 years.)
Overall survival (OS)(From the day of BAFFR-CAR T cell infusion to death from any cause assessed, up to 15 years.)
Severity of graft-versus-host disease (GVHD) in recipients of prior allogeneic hematopoietic stem cell transplantation(Up to 1 year post treatment.)