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

Launched by ZHUJIANG HOSPITAL · Jan 16, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a type of leukemia called relapsed/refractory B-ALL, particularly those whose cancer has come back after previous treatment with a special therapy called CD19 CAR T-cell treatment. In some cases, the leukemia cells stop showing the CD19 marker, making it harder to target them. This trial is exploring whether a sequential treatment using CAR T-cells that target other markers (CD20, CD22, and CD10) can help eliminate these hard-to-treat cancer cells and extend the time patients remain free of disease.

To be eligible for this trial, patients must have B-ALL that has returned after not responding to standard chemotherapy, and they should have certain markers on their leukemia cells (CD19 and CD20/CD22/CD10/CD70 positive). Participants can expect to receive the new treatment after their initial CD19 CAR T-cell therapy. The trial is currently recruiting participants aged between 6 months and 21 years, and it is important for those interested to discuss with their healthcare team whether this trial is a suitable option for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Relapsed/Refractory B-ALL patients
• • 2. Did not achieve complete remission after 2 times of standard plan chemotherapy
• • 3. Relapsed after first induction chemotherapy
• • 4. Did not response to chemotherapy before HSCT or relapsed after HSCT
• • 5. Cannot receive allo-HSCT or refuse to receive allo-HSCT
• • 6. Cell phenotype is CD19 and CD20/CD22/CD10/CD70 positive (single or combined)
• • 7. Estimated survival time is more than 3 months in leukemia
• • 8. Volunteered for this clinical trail and signed a consent form
• Exclusion Criteria:
• • 1. MRD was negative while the cell phenotype was CD19 expressed
• • 2. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
• • 3. Patients with severe mental illness, neurological disease or infectious disease
• • 4. Patients with GVHD was taking immunosuppressants
• • 5. Pregnant or lactating women
• • 6. Patients have received other genetic therapy products
• • 7. Transfection efficiency was less than 30%
• • 8. Any situation may do harm to the subjects or interfere the results