Trials / Recruiting
RecruitingNCT04532268
A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL
Clinical Trial for the Safety and Efficacy of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- Zhejiang University · Academic / Other
- Sex
- All
- Age
- 3 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.
Detailed description
This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-cell hematological malignancies, including acute lymphoblastic leukemia and B-cell non-Hodgkin's lymphoma. The selections of dose levels and the numberof subjects are based on clinical trials of similar foreign products. Two groups of patients will be enrolled, 36 in each group. Primary objective is to explore the safety, main consideration is dose-related safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Humanized CD19 CAR-T cells | Each subject receive humanized CD19 CAR T-cells by intravenous infusion |
Timeline
- Start date
- 2020-08-23
- Primary completion
- 2023-08-23
- Completion
- 2026-08-23
- First posted
- 2020-08-31
- Last updated
- 2020-08-31
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04532268. Inclusion in this directory is not an endorsement.