NCT04714593

Targeting CD19 and CD22 CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory Acute B Lymphocytic Leukemia

A Clinical Study to Evaluate the Safety and Effectiveness of CD19- BCMA CAR - T Cells Immunotherapy in Patients With Relapsed or Refractory Acute B Lymphocytic Leukemia

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanxi Province Cancer Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of CD19-CD22 CAR-T cells for the treatment of acute B lymphocytic leukemia.

Detailed description

A non randomized study ,plans to enrollment 24 subjects of acute B lymphocytic leukemia .The subjects will divide into low, medium and high dose groups，to evaluate the safety and tolerability of CD19-CD22 CAR - T cells，to evaluate the preliminary efficacy and observe PK/PD parameters of CD19-CD22 CAR -T cells immunotherapy in patients with relapsed or refractory acute B lymphocytic leukemia .

Conditions

• Acute Lymphocytic Leukemia， B-Cell

Interventions

Type	Name	Description
BIOLOGICAL	CD19-CD22 CAR-T cells	A autologous doping CAR - T cells injection targets with CD19 and CD22，fluorine dara marina injection(30 mg/m2，QD×3d) and cyclophosphamide injection (300 mg/m2，QD×3d)will be used to remove the lymphocyte before infusion CD19-CD22 CAR-T cells .

Timeline

• Start date: 2021-01-15
• Primary completion: 2021-12-31
• Completion: 2023-12-31
• First posted: 2021-01-19
• Last updated: 2021-01-22

Locations

1 site across 1 country: China