Bispecific CD19/CD22 CAR-T for Treatment of Children and Young Adults With r/r B-ALL

Phase 1/2 Active not recruiting 50 enrolled Federal Research Institute of Pediatric Hematology, Oncology and Immunology

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficiency of autologous CD19/CD22 CAR-T lymphocytes in a cohort of pediatric and young adult patients with relapsed /refractory B-lineage acute lymphoblastic leukemia

Timeline

Start: 2020-07-27
Primary completion: 2022-03-13
Completion: 2027-03-13

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CD19/CD22 CAR-T	Cell therapy	0.1 cells/kg	Other
Subject	CD19/CD22 CAR-T	Cell therapy	0.15 cells/kg	Other
Subject	CD19/CD22 CAR-T	Cell therapy	0.5 cells/kg	Other
Subject	CD19/CD22 CAR-T	Cell therapy	0.85 cells/kg	Other
Subject	CD19/CD22 CAR-T	Cell therapy	1.5 cells/kg	Other
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	—
Background	Cytarabine	Small molecule	900 mg/m2	—
Background	Dexamethasone	Small molecule	30 mg/m2	—
Background	Etoposide	Small molecule	450 mg/m2	—
Background	Fludarabine	Small molecule	120 mg/m2	—
Background	Tocilizumab	Monoclonal antibody	8 mg/kg	Intravenous

Indications

No indication recorded.