RecruitingEarly Phase 1NCT03407859
Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment Base on MRD in Relapsed/Refractory B-ALL
Sponsor
Zhujiang Hospital
Enrollment
100 participants
Start Date
Jan 18, 2016
Study Type
INTERVENTIONAL
Conditions
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 new targets in treatment of CD19-negative relapse of B-ALL. Thus sequential treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL will kill and eliminate CD19 negative B-ALL cells and prolong the remission time.
Eligibility
Min Age: 18 YearsMax Age: 60 Years
Inclusion Criteria8
- 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 Criteria8
- 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
Interventions
BIOLOGICALSequential Treatment With different CART
Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment in Relapsed/Refractory B-ALL
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03407859