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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

December 18, 2018

Primary Completion Date

February 9, 2024

Study Completion Date

June 1, 2028

Conditions
Acute Lymphoblastic LeukemiaLarge B-cell Lymphoma
Interventions
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.

Trial Locations (1)

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT03642626 - MT2017-45: CAR-T Cell Therapy for Heme Malignancies | Biotech Hunter | Biotech Hunter