Trials / Recruiting
RecruitingNCT07244406
Assessment of Senl_B19 CAR-T Cells in Relapsed/Refractory CD19+ B-ALL
A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Senl_B19 Autologous Anti-CD19 CAR-T Cells in Subjects With Relapsed or Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (estimated)
- Sponsor
- Hebei Senlang Biotechnology Inc., Ltd. · Industry
- Sex
- All
- Age
- 3 Years – 25 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.
Detailed description
The primary objective: To evaluate the efficacy of S1904 in pediatric and adult subjects with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia. The secondary objectives: To further characterize the efficacy and safety profiles of S1904 in this patient population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | S1904 CD19 CAR-T | Autologous CD19-targeting CAR T cells |
Timeline
- Start date
- 2025-01-10
- Primary completion
- 2027-03-31
- Completion
- 2028-12-31
- First posted
- 2025-11-24
- Last updated
- 2025-11-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07244406. Inclusion in this directory is not an endorsement.