NCT04336501

Efficacy and Safety Evaluation of IM19 CAR-T Cell Therapy for MRD+ After Transplantation

Efficacy Study About Donor Derived CD19-target T Cell to Treat B-ALL Post Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Efficacy study about donor derived CD19-target T cell to treat B-ALL post hematopoietic stem cell transplantation

Detailed description

Allogeneic hematopoietic stem cell transplantation (allo-hsct) for the treatment of refractory recurrent acute b-lymphoblastic leukemia (b-all), the overall survival rate of 3 years after transplantation was about 10%. The overall survival rate at 3 years was about 70 percent. In the early stage, the investigators established the monitoring method of leukemia micro-residual disease, effectively screened out the high-risk group of recurrence, combined with the new relapse treatment method, successfully implemented the stratification and even personalized dry prediction of leukemia recurrence for the first time in the world, and reduced the recurrence rate of the high-risk group by 30%. However, the therapeutic targeting is not strong, and up to 30% of patients will develop graft versus host disease, which seriously affects the survival of patients. The use of CAR repair T cells (CAR T) to target CD19 in the treatment of refractory recurrent b-all was effective, and the use of CAR T in the treatment of recurrent b-all after transplantation did not increase the risk of GVHD. This clinical study mainly discussed the safety and efficacy of donor targeted cd19-t cells after allo-hsct in the treatment of acute b-lymphocytic leukemia with minimal residual disease. It is expected that the recurrence rate will be reduced while the incidence of acute GVHD after transplantation will not be increase

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	IM19 CAR-T	All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-04-07
• Last updated: 2020-12-17

Locations

1 site across 1 country: China