CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies

Early Phase 1

Recruiting

• Conditions: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia; Relapsed or Refractory B-cell Non-hodgkin Lymphoma
• Interventions: Biological: Anti-CD19 Universal CAR-T Cells injection

• Registration Number: NCT05105867
• Lead Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Brief Summary

It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.

Detailed Description

The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.

Study Timeline

• Study Start: 2021-09-29
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10
• Primary Completion: 2024-08-31
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Eastern Cooperative Oncology Group Performance Status of 0 or 1；
2. Expected survival time ≥12 weeks;
3. Adequate hematological, renal and liver function;
4. Subjects understand and voluntarily sign the informed consent form.

Key

Exclusion Criteria

1. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;
2. Cyclophosphamide or fludarabine is contraindicated for subjects ;
3. Active central nervous system (CNS) involvement by malignancy；
4. Active infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-CD19 Universal CAR-T Cells injection	Anti-CD19 Universal CAR-T Cells injection	Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion .

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities	Up to 4 weeks after CAR-T infusion	Incidence of dose-limiting toxicities as protocol-defined

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	At 4,12,24 weeks after CAR-T infusion	Objective response rate after CAR-T infusion

Trial Locations

Locations (1)

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China; 🇨🇳 Kunming, Yunnan, China