Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment Base on MRD in Relapsed/Refractory B-ALL

  • STATUS
    Recruiting
  • days left to enroll
    64
  • participants needed
    30
  • sponsor
    Zhujiang Hospital
Updated on 16 August 2021

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.

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 revolutionary targeted immunotherapy. CD19 CAR-T is the most commonly used engineered T cell in B-ALL. The treatment effect is significant and far more than traditional therapy in relapsed/refractory B-ALL. However, the remission time after CD19 CAR-T infusion is short.CD19-positive and CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients The cause of relapse after CAR-T infusion is minimal residual disease (MRD) which will induce CD19 negative relapse. 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.

Details
Condition Therapy Related Leukemia
Treatment Sequential Treatment With different CART
Clinical Study IdentifierNCT03407859
SponsorZhujiang Hospital
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Relapsed after CD19-CART infusion
MRD monitoring confirmed positive(MRD>0.01%) after CD19-CART infusion
Cell phenotype is CD19 negative and CD20/CD22/CD10 positive (single or combined) after CD19-CART therapy
Estimated survival time is more than 3 months in leukemia
Volunteered for this clinical trail and signed a consent form

Exclusion Criteria

MRD was negative after CD19-CART therapy
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
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