Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma (EVOLVE)
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 and/or refractory multiple myeloma. The study will include a Phase 1 part to determine the recommended dose of JCARH125 in subjects with relapsed and/or refractory multiple myeloma, followed by a Phase 2 part to further evaluate the safety and efficacy of JCARH125 at the recommended dose.
June 01, 2018
Cancer (Hematology) - Multiple Myeloma / Plasma Cell Malignancies,
William Bensinger, M.D.
Juno Therapeutics, Inc.
Swedish Cancer Institute
|Ages Eligible for Study:
||18 Years and older (Adult, Older Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Key Inclusion Criteria:
Diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Participants must have received at least 3 prior lines of therapy. Participants must have previously received all of the following therapies and must be refractory to the last line of therapy prior to entering the study:
- Autologous stem cell transplant
- A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or in combination
- 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.
- Subjects must have measurable disease.
- Subject must be willing to provide fresh bone marrow samples during Screening (and prior to study treatment, if required).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate renal, bone marrow, hepatic, pulmonary, and cardiac function
- Subjects with known active or history of CNS involvement by malignancy
- Subjects with solitary plasmacytoma; active or history of plasma cell leukemia (PCL); Waldenstrom's macroglobulinemia; Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome; or symptomatic amyloidosis
- Subjects who are considered eligible to receive an autologous stem cell transplant
- 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.
- 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])
- Prior CAR T-cell or other genetically-modified T-cell therapy
- Prior treatment with a BCMA-targeted agent
- Prior allogeneic stem cell transplant
- 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