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

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

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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota

  lead OTHER

Principal Investigators

• Veronika Bachanova, MD, PhD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-18

Primary Completion

2024-02-09

Completion

2028-06-01

FDA Drug

Yes

Countries

• United States

Study Locations