Trials / Unknown
UnknownNCT05105867
CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies
A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
- Relapsed or Refractory B-cell Non-hodgkin Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Anti-CD19 Universal CAR-T Cells injection | Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion. |
Timeline
- Start date
- 2021-09-29
- Primary completion
- 2024-08-31
- Completion
- 2024-11-30
- First posted
- 2021-11-03
- Last updated
- 2023-05-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05105867. Inclusion in this directory is not an endorsement.