NCT03642626

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

Chimeric Antigen Receptor (CAR)-T Cell Therapy for Patients With Hematologic Malignancies

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukemia
• Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	KYMRIAH	FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
DRUG	YESCARTA	CD19-directed genetically modified autologous T cell immunotherapy
DRUG	Fludarabine 30mg/m2 4 doses	30 mg/m2 IV daily for 4 doses
DRUG	Cyclophosphamide 500 mg/m2; 2 doses	500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
DRUG	Fludarabine 30mg/m2 3 doses	30 mg/m2 IV daily for 3 doses
DRUG	Cyclophosphamide 500 mg/m2; 3 doses	500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
DRUG	Fludarabine 25mg/m2 3 days	25 mg/m2 i.v. daily for 3 days
DRUG	Cyclophosphamide 250 mg/m2; 3 days	250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
DRUG	Tecartus	TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
DRUG	Abecma, Intravenous Suspension	Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
DRUG	Cyclophosphamide 900 mg/m2; 1 day	Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
DRUG	Breyanzi Injectable Product	Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.

Timeline

• Start date: 2018-12-18
• Primary completion: 2024-02-09
• Completion: 2028-06-01
• First posted: 2018-08-22
• Last updated: 2026-01-23
• Results posted: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study