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.
The subject or guardian understands and voluntarily signs the Informed Consent Form (ICF);
Male or female, aged 12-65 years (including the cutoff value) when signing the informed consent form;
Expected survival period is not less than 12 weeks;
ECOG physical performance score is 0-1 when signing the ICF;
Isolated extramedullary relapse;
Burkitt's lymphoma/leukemia;
Previous history of CNS disease, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy (except inactive CNS leukemia);
Previous hematopoietic stem cell transplantation;
Parallel
Senl_B19 autologous CAR-T (S1904) treatment
Biological/VaccineSubjects enrolled in this study will first receive Senl\_B19 autologous CAR-T (S1904) treatment.
2-year event-free survival after randomization
The time from randomization to MRD positive or relapse or death due to non-relapse causes (whichever occurs first)
2-year relapse-free survival after randomization
Time from randomization to relapse or death from any cause (whichever occurs first)
Cumulative incidence of relapse
Time from randomization to relapse
2-year overall survival after randomization
Time from randomization to death from any cause
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Peking University People's Hospital
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
