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

The 920th Hospital of The Joint Logistics Support Force of the Chinese People's Liberation Army

Status and phase: Enrolling; Early Phase 1

Conditions: Relapsed or Refractory B-cell Non-hodgkin Lymphoma; Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Treatments: Biological: Anti-CD19 Universal CAR-T Cells injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05105867

GC011-411

Details and patient eligibility

About

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.

Full description

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Anti-CD19 Universal CAR-T Cells injection

Experimental group

Description:

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

Treatment:

Biological: Anti-CD19 Universal CAR-T Cells injection