NCT03919526

Anti-CD19/CD22 Bispecific Chimeric Antigen Receptor（CAR)-T Cell Therapy for Measurable Residual Disease(MRD) Positive ALL

The Safety and Clinical Efficacy of Human CD19/CD22 Bispecific Chimeric Antigen Receptor (CAR)-T Cell Therapy for Subjects With Measurable Residual Disease(MRD)-Positive B Cell Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of CD19/CD22 Bispecific chimeric antigen receptor (CAR)-T for the treatment of measurable residual disaese (MRD)-positive B cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells.

Detailed description

Participants with MRD-positive B cell acute lymphoblastic leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI , and blood draws. Participants receive chemotherapy prior to the infusion of CD19/CD22 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19/CD22 CAR+ T cells. Study procedures may be performed while hospitalized.

Conditions

• MRD-positive
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19/CD22 CAR-T cells	Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs
DRUG	Fludarabine	30mg/m2/d
DRUG	Cyclophosphamide	300mg/m2/d

Timeline

• Start date: 2019-08-11
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2019-04-18
• Last updated: 2023-12-08

Locations

1 site across 1 country: China