Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in R/R Acute B Lymphoblastic Leukemia

• Status: Withdrawn
• Trial end date: 2020-08-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory acute B lymphoblastic leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
• Collaborator: Nanjing Legend Biotech Co.
• Treatments: Immunologic Factors

Criteria

Inclusion Criteria:

1. Written informed consent could be acquired;

2. Diagnosed with relapse/refractory acute lymphoblastic leukemia;

3. Relapse was defined as recurrence of blast cell(more than 5%) in peripheral blood or in bone marrow or extramedullary involvement;

4. Refractory was defined as failed to achieve complete remission after two courses of induction therapy;

5. CD19/CD22 postive leukemia cell was confirmed by flow cytometry or immunohistochemistry within 90 days since enrollment in this trial;

6. Karnofsky score ≥70;

7. Results of pregnant test should be negative, and agree to conception control during treatment and 6 months after CAR-T infusion.

8. Adequate organ function: EF≥50%; normal ECG; CCR ≥ 50ml/min or Cr < 2.0mg/dL or < 2 times upper limitation of normal; ALT and AST<5 times upper limitation of normal; Serum bilirubin ≤ 3.0mg/dL; DLCO or FEV1 > 45% of predict value;

9. At least 2 weeks intervals since the last chemotherapy;

10. At least 2 weeks intervals since the last anti-GVHD therapy if patients have ever ;

Exclusion Criteria:

1. Patients diagnosed with acute promyelocytic leukemia:t(15;17)(q22;q12);

2. Women in pregnancy and lactation;

3. Uncontrolled infection, Active HBV or HCV infection, HIV positive or any other deadly bacterial/virual diseases;

4. Long term use of systemic corticosteroids(5mg per day for 2 weeks);

5. Any other uncontrolled life-threaten diseases;

6. Patients with history of anaphylaxis to any drugs;

7. With central nervous system (CNS) involvement;

8. Patients with GVHD after allo-HSCT who needed immunosuppressive agents ;

9. Patients with acute autoimmune diseases such as psoriasis or rheumatoid arthritis;

10. Other conditions that principle investigator considered may increase the risk of the patients or interference the results.