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

Phase 1/2 Unknown 18 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 CAR-T lymphocytes in a cohort of pediatric and young adult patients with relapsed /refractory B-lineage acute lymphoblastic leukemia

Timeline

Start: 2018-05-14
Primary completion: 2020-10-15
Completion: 2025-10-15

Publications

Maschan M, Caimi PF, Reese-Koc J, Sanchez GP, Sharma AA, Molostova O, Shelikhova L, Pershin D, Stepanov A, Muzalevskii Y, Suzart VG, Otegbeye F, Wald D, Xiong Y, Wu D, Knight A, Oparaocha I, Ferencz B, Roy A, Worden A, Kruger W, Kadan M, Schneider D, Orentas R, Sekaly RP, de Lima M, Dropulic B. Multiple site place-of-care manufactured anti-CD19 CAR-T cells induce high remission rates in B-cell malignancy patients. Nat Commun. 2021 Dec 10;12(1):7200. doi: 10.1038/s41467-021-27312-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CAR19	Cell therapy	100000 cells/kg	Intravenous
Subject	CAR19	Cell therapy	500000 cells/kg	Intravenous
Subject	CAR19	Cell therapy	1e+06 cells/kg	Intravenous
Subject	CAR19	Cell therapy	3e+06 cells/kg	Intravenous
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Background	Cytarabine	Small molecule	900 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	30 mg/m2	Intravenous
Background	Etoposide	Small molecule	450 mg/m2	Intravenous
Background	Fludarabine	Small molecule	120 mg/m2	Intravenous
Background	Tocilizumab	Monoclonal antibody	8 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications