Trials / Recruiting
RecruitingNCT06927466
A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- Sponsor
- Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 3 Years – 25 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | B019 | B019： Intravenous infusion, 1.0×10\^6 CAR T cell/kg-10.0×10\^6 CAR T cell/kg |
Timeline
- Start date
- 2024-09-19
- Primary completion
- 2026-01-31
- Completion
- 2028-06-30
- First posted
- 2025-04-15
- Last updated
- 2025-05-22
Locations
8 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06927466. Inclusion in this directory is not an endorsement.