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

Description

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.

Study Start Date

February, 01 2018

Estimated Completion Date

March 2021

Interventions

  • Biological: JCARH125

Study ID

Juno Therapeutics, Inc. -- H125001

Status

Recruiting

Trial ID

NCT03430011

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

118

Sponsor

Juno Therapeutics, Inc.

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Memorial Sloan Kettering Cancer Center - New York, New York 50.7 miles Claudia Diamonte RN 212-639-5317 diamontc@mskcc.org

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