Status:
RECRUITING
Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment Base on MRD in Relapsed/Refractory B-ALL
Lead Sponsor:
Zhujiang Hospital
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
Conditions:
Therapy Related Leukemia
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become ne...
Detailed Description
B-cell acute lymphoblastic leukemia is the most common type of leukemia and the prognosis of relapsed/refractory B-ALL is poor. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of re...
Eligibility Criteria
Inclusion
- Relapsed/Refractory B-ALL patients
- Did not achieve complete remission after 2 times of standard plan chemotherapy
- Relapsed after first induction chemotherapy
- Did not response to chemotherapy before HSCT or relapsed after HSCT
- Cannot receive allo-HSCT or refuse to receive allo-HSCT
- Cell phenotype is CD19 and CD20/CD22/CD10/CD70 positive (single or combined)
- Estimated survival time is more than 3 months in leukemia
- Volunteered for this clinical trail and signed a consent form
Exclusion
- MRD was negative while the cell phenotype was CD19 expressed
- Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
- Patients with severe mental illness, neurological disease or infectious disease
- Patients with GVHD was taking immunosuppressants
- Pregnant or lactating women
- Patients have received other genetic therapy products
- Transfection efficiency was less than 30%
- Any situation may do harm to the subjects or interfere the results
Key Trial Info
Start Date :
January 18 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03407859
Start Date
January 18 2016
End Date
March 31 2025
Last Update
March 15 2024
Active Locations (1)
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1
Southern Medical University Zhujiang Hospital
Guangdong, Guangdong, China, 510000