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

NCT03642626 | Active Not Recruiting Phase 2 Results FDA Drug

• 3 other identifiers: 2017LS118MT2017-45NCI-2020-04527
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ALL; CAR-T; CAR19-T; chimeric antigen receptor T cells

Outcome Measures

Primary Outcomes (2)

• Arms B & C&D& E&F: Overall Response Rate (ORR)

  ORR defined by complete response + partial response by Lugano

  Day 100

• Arm A & E: MRD-negative CR (or CRi)

  Percentage of patients with MRD-negative Complete Response CR (or CRi)

  Day 28

Secondary Outcomes (8)

• Percentage of Patients Developing Grade 3 or 4 ICANS

  Day 28

• Treatment Related Mortality (TRM)

  Day 28

• Treatment Related Mortality (TRM)

  Day 100

• Treatment Related Mortality (TRM)

  1 Year

• Relapse-free Survival (RFS)

  1 year

Study Arms (7)

ARM A: Refractory/relapsed B-cell acute lymphoblastic leukemia (ALL)

EXPERIMENTAL

Drug: KYMRIAH; Drug: Fludarabine 30mg/m2 4 doses; Drug: Cyclophosphamide 500 mg/m2; 2 doses

ARM B: Yescarta for Refractory diffuse large B cell lymphoma (DLBCL)

EXPERIMENTAL

Drug: YESCARTA; Drug: Fludarabine 30mg/m2 3 doses; Drug: Cyclophosphamide 500 mg/m2; 3 doses

ARM C: Kymriah for Refractory diffuse large B cell lymphoma (DLBCL)

EXPERIMENTAL

Drug: KYMRIAH; Drug: Fludarabine 25mg/m2 3 days; Drug: Cyclophosphamide 250 mg/m2; 3 days

Arm D: Tecartus CAR-T product for Mantle Cell Leukemia (MCL)

EXPERIMENTAL

Drug: Fludarabine 30mg/m2 3 doses; Drug: Cyclophosphamide 500 mg/m2; 3 doses; Drug: Tecartus

Arm E: Breyanzi for relapsed or refractory large B-cell lymphoma (RLBCL)

EXPERIMENTAL

Drug: Fludarabine 30mg/m2 3 doses; Drug: Cyclophosphamide 500 mg/m2; 3 doses; Drug: Breyanzi Injectable Product

Arm F: Abecma for relapsed or refractory multiple myeloma

EXPERIMENTAL

Drug: Fludarabine 30mg/m2 3 doses; Drug: Cyclophosphamide 500 mg/m2; 3 doses; Drug: Abecma, Intravenous Suspension

Arm G: Tecartus B-cell acute lymphoblastic leukemia (ALL)

EXPERIMENTAL

Drug: Fludarabine 25mg/m2 3 days; Drug: Tecartus; Drug: Cyclophosphamide 900 mg/m2; 1 day

Interventions

YESCARTA DRUG

CD19-directed genetically modified autologous T cell immunotherapy

ARM B: Yescarta for Refractory diffuse large B cell lymphoma (DLBCL)

Fludarabine 30mg/m2 4 doses DRUG

30 mg/m2 IV daily for 4 doses

ARM A: Refractory/relapsed B-cell acute lymphoblastic leukemia (ALL)

Cyclophosphamide 500 mg/m2; 2 doses DRUG

500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine

ARM A: Refractory/relapsed B-cell acute lymphoblastic leukemia (ALL)

Fludarabine 30mg/m2 3 doses DRUG

30 mg/m2 IV daily for 3 doses

ARM B: Yescarta for Refractory diffuse large B cell lymphoma (DLBCL); Arm D: Tecartus CAR-T product for Mantle Cell Leukemia (MCL); Arm E: Breyanzi for relapsed or refractory large B-cell lymphoma (RLBCL); Arm F: Abecma for relapsed or refractory multiple myeloma

Cyclophosphamide 500 mg/m2; 3 doses DRUG

500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine

ARM B: Yescarta for Refractory diffuse large B cell lymphoma (DLBCL); Arm D: Tecartus CAR-T product for Mantle Cell Leukemia (MCL); Arm E: Breyanzi for relapsed or refractory large B-cell lymphoma (RLBCL); Arm F: Abecma for relapsed or refractory multiple myeloma

Fludarabine 25mg/m2 3 days DRUG

25 mg/m2 i.v. daily for 3 days

ARM C: Kymriah for Refractory diffuse large B cell lymphoma (DLBCL); Arm G: Tecartus B-cell acute lymphoblastic leukemia (ALL)

Cyclophosphamide 250 mg/m2; 3 days DRUG

250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine

ARM C: Kymriah for Refractory diffuse large B cell lymphoma (DLBCL)

Tecartus DRUG

TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells

Also known as: Brexucabtagene Autoleucel

Arm D: Tecartus CAR-T product for Mantle Cell Leukemia (MCL); Arm G: Tecartus B-cell acute lymphoblastic leukemia (ALL)

Abecma, Intravenous Suspension DRUG

Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.

Arm F: Abecma for relapsed or refractory multiple myeloma

Cyclophosphamide 900 mg/m2; 1 day DRUG

Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS

Arm G: Tecartus B-cell acute lymphoblastic leukemia (ALL)

Breyanzi Injectable Product DRUG

Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.

Arm E: Breyanzi for relapsed or refractory large B-cell lymphoma (RLBCL)

KYMRIAH DRUG

FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells

Also known as: tisagenlecleucel

ARM A: Refractory/relapsed B-cell acute lymphoblastic leukemia (ALL); ARM C: Kymriah for Refractory diffuse large B cell lymphoma (DLBCL)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age and Disease Status
• Must be age 0-25 years (for Arm A Kymriah) or \>18 years (Arm G Tecartus)
• Disease status: Relapsed and refractory pediatric B-cell ALL defined by one of these:
• Primary induction failure with no complete remission after ≥2 cycles of induction chemotherapy, or
• Patients with persistent minimal residual disease (MRD \>0.01% by flow cytometry or persistent by cytogenetic or molecular assays) after ≥2 cycles of consolidation chemotherapy, or
• Patients in 2nd or greater relapse of B-ALL or
• Patients with persistent CNS leukemia, or
• Down Syndrome or other congenital diseases assuming that they fit the criteria for second or greater relapse or refractory leukemia, or
• Patients with Ph+ ALL are eligible if theywho have failed or are intolerant to two lines of TKI assuming they fit the criteria for second or greater relapse or are considered refractory.
• Performance Status
• \* Arm A: Karnofsky (age ≥16 years) or Lansky (age \< 16 years) performance status ≥ 50% at screening; Arm G: ECOG 0, 1 or 2
• Organ Function
• Renal function defined as:
• A serum creatinine of ≤1.5 x ULN OR
• eGFR ≥ 50 mL/min/1.73 m2

You may not qualify if:

• Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell \[sIg positive and kappa or lambda restricted positivity\] ALL, with FAB L3 morphology and /or a MYC translocation)
• CNS 2A
• CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to enrollment.
• Patient has taken one of the prohibited concomitant medications within the timeframe outlined in section 6.1
• ARM B: Yescarta for Relapsed or Refractory diffuse large B cell lymphoma
• Age and Disease Status

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

tisagenlecleucel; axicabtagene ciloleucel; fludarabine; Cyclophosphamide; brexucabtagene autoleucel

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Veronika Bachanova
• Organization: Masonic Cancer Center

bach0173@umn.edu

612-625-5469

Study Officials

• Veronika Bachanova, MD, PhD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 22, 2018
• Study Start: December 18, 2018
• Primary Completion: February 9, 2024
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2026-01

Locations

US (1)