Trials / Recruiting
RecruitingNCT06581081
Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T (S1904) Cell Therapy for r/r B-cell Acute Lymphoblastic Leukemia
Bridging Allogeneic Hematopoietic Stem Cell Transplantation or Not After CD19 CAR - T (S1904) Cell Therapy for r/r B-cell Acute Lymphoblastic Leukemia, a Prospective, Open, Multicenter, Randomized, Control Study (COMPLETE Study)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Peking University People's Hospital · Academic / Other
- Sex
- All
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Traditional salvage chemotherapy has low efficacy and poor long-term prognosis for relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). Targeted CD19 CAR-T cell immunotherapy is an effective means of treating R/R B-ALL. Several clinical studies have shown that its remission rate for R/R B-ALL can reach 68-93%. However, long-term follow-up found that the remission time after CD19 CAR-T treatment is short and the relapse rate is high. Therefore, how to ensure the long-term survival of R/R B-ALL patients after remission by CAR-T therapy is an urgent problem to be solved. Some studies have shown that timely bridging allo-HSCT after CAR-T treatment can overcome the risk of relapse and further improve the long-term survival of patients. However, there is currently no randomized controlled study on whether to bridge transplantation after CAR-T. The purpose of this study is to evaluate the efficacy and safety of S1904 in the treatment of relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia with or without bridging to allogeneic hematopoietic stem cell transplantation after remission.
Conditions
- Relapsed Adult ALL
- B-cell Acute Lymphoblastic Leukemia
- Refractory Acute Lymphoblastic Leukemia
- Relapsed Pediatric ALL
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Senl_B19 autologous CAR-T (S1904) treatment | Subjects enrolled in this study will first receive Senl\_B19 autologous CAR-T (S1904) treatment. |
Timeline
- Start date
- 2024-10-01
- Primary completion
- 2027-08-31
- Completion
- 2029-08-31
- First posted
- 2024-08-30
- Last updated
- 2025-03-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06581081. Inclusion in this directory is not an endorsement.