Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and / or Refractory Multiple Myeloma
Trial Status: Active
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.
- Diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Participants must have received at least 3 prior anti-myeloma treatment regimens. 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 have received prior allogeneic stem cell transplant at least 100 days before enrollment with no signs of acute or chronic graft-versus-host disease (GVHD) will be considered eligible. 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 and have not refused an autologous stem cell transplant
- History of another primary malignancy that has not been in remission for at least 3 years. The following are exempt from the 3-year limit: non-melanoma skin cancer, 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
- 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
- Untreated or active infection at time of initial screening, at the time of leukapheresis, within 72 hrs before lymphodepletion, or 5 days before JCARH125 infusion.
- History of any of the following cardiovascular conditions within 6 months of screening: Class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac disease
University of Alabama at Birmingham Cancer Center
Contact: Luciano Jose Megale Costa
City of Hope Comprehensive Cancer Center
UCLA / Jonsson Comprehensive Cancer Center
Contact: Vlad Kustanovich
UCSF Medical Center-Mount Zion
Contact: Sandy W. Wong
Emory University Hospital / Winship Cancer Institute
University of Chicago Comprehensive Cancer Center
University of Kansas Cancer Center
University of Kansas Hospital-Westwood Cancer Center
Wayne State University / Karmanos Cancer Institute
Hackensack University Medical Center
Roswell Park Cancer Institute
Memorial Sloan Kettering Cancer Center
Fred Hutch / University of Washington Cancer Consortium
Trial Phase Phase I/II
Trial Type Treatment
Juno Therapeutics, Inc.
- Primary ID H125001
- Secondary IDs NCI-2018-00365
- Clinicaltrials.gov ID NCT03430011