RecruitingNot ApplicableNCT06581081

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)


Sponsor

Peking University People's Hospital

Enrollment

130 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches after CAR-T cell therapy for relapsed or treatment-resistant B-cell acute lymphoblastic leukemia (B-ALL): getting a stem cell transplant versus not getting one. CAR-T therapy reprograms immune cells to attack cancer, and this trial tests whether transplant after remission improves long-term outcomes. **You may be eligible if...** - You are between 12 and 65 years old - You have B-cell ALL that has come back or hasn't responded to standard treatment - Your expected survival is at least 12 weeks - Your overall health and organ function meet the study requirements **You may NOT be eligible if...** - You have active, uncontrolled infection or severe organ damage - You have previously received CAR-T therapy - You have cancer that has spread to the central nervous system in an active way Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSenl_B19 autologous CAR-T (S1904) treatment

Subjects enrolled in this study will first receive Senl\_B19 autologous CAR-T (S1904) treatment.


Locations(1)

Peking University People'S Hospital

Beijing, Beijing Municipality, China

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NCT06581081


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