Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed or Refractory Multiple Myeloma
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
- Biological: JCARH125
Juno Therapeutics, Inc. -- H125001
Phase 1/Phase 2
Juno Therapeutics, Inc.
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
1. Autologous stem cell transplant
2. A combination regimen that included both an immunomodulatory agent (eg,
lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib,
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
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
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
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
|Memorial Sloan Kettering Cancer Center - New York, New York||50.7 miles||Claudia Diamonte RNemail@example.com|