Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed or Refractory Multiple Myeloma (EVOLVE)

Overview

This is an open-label, multicenter, Phase 1/2 study to determine the safety and efficacy of JCARH125, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose.

Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCARH125. During JCARH125 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JCARH125 product, participants will receive a course of lymphodepleting chemotherapy followed by one dose of JCARH125 administered intravenously (IV).

SparkCures ID 940
Trial Phase Phase 1/2
Enrollment 118 Patients
Treatments
Trial Sponsors
  • Juno Therapeutics, Inc.
NCT Identifier

NCT03430011

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Key Inclusion Criteria:

  1. Diagnosis of multiple myeloma (MM) with relapsed or refractory disease after at least 3 prior lines of therapy that are considered standard of care. Prior lines of therapy include:

    1. Autologous stem cell transplant
    2. A combination regimen that included both an immunomodulatory agent (eg, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib)
    3. Anti-CD38 (eg, daratumumab) as part of a combination regimen or as a monotherapy

    Subjects who were not candidates to receive one or more of the above treatments (ie, contraindicated) are eligible. For subjects who exhibited duration of response > 12 months to immediate prior line of therapy, administration of an additional line of available therapy in lieu of JCARH125 should be considered.

  2. Subjects must have measurable disease.
  3. Subject must be willing to provide fresh bone marrow samples during Screening and prior to study treatment.
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  5. Adequate renal, bone marrow, hepatic, pulmonary, and cardiac function

Exclusion Criteria:

  1. Subjects with known active CNS involvement by malignancy. Subjects with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging.
  2. Subjects with plasma cell leukemia (PCL) or symptomatic amyloidosis. Subjects with a history of PCL are not excluded.
  3. Subjects who are considered eligible to receive an autologous stem cell transplant
  4. History of another primary malignancy that has not been in remission for at least 2 years. The following are exempt from the 2-year limit: non-melanoma skin cancer, completely resected Stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.
  5. Require systemic immunosuppressive therapies (eg, calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-IL-6 or anti-IL-6 receptor [IL-6R])
  6. Prior CAR T-cell or other genetically-modified T-cell therapy
  7. Prior treatment with a BCMA-targeted agent
  8. Prior allogeneic stem cell transplant
  9. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Verified Medical College of Wisconsin<br />Froedtert Hospital

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Alabama
California
Georgia
Verified Winship Cancer Institute of Emory University<br />

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Illinois
Kansas
Maryland
New Jersey
Verified John Theurer Cancer Center<br />Hackensack Meridian Health

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New York
Washington
Wisconsin
Verified Medical College of Wisconsin<br />Froedtert Hospital

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Resources

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