MT2017-45: CAR-T Cell Therapy for Heme Malignancies

Phase 2 Active not recruiting 150 enrolled Masonic Cancer Center, University of Minnesota

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a phase II study of FDA-approved CAR-T products for patients with hematologic malignancies. Patients will be assigned to Arm A and B based on age and diagnosis. Overall remission rate, safety events and other endpoints will be calculated for Arm A and B separately.

Timeline

Start: 2018-12-18
Primary completion: 2024-02-09
Completion: 2028-06-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Axicabtagene Ciloleucel	Cell therapy	—	—
Subject	Brexucabtagene Autoleucel	Cell therapy	—	—
Subject	Lisocabtagene Maraleucel	Cell therapy	—	—
Subject	Tisagenlecleucel	Cell therapy	—	—
Subject	idecabtagene vicleucel	Cell therapy	—	Intravenous
Background	Cyclophosphamide	Other / unclassified	250 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	500 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	900 mg/m2	—
Background	Fludarabine	Small molecule	25 mg/m2	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous

MT2017-45: CAR-T Cell Therapy for Heme Malignancies

Summary

Timeline

Drugs

Indications