Multiple Myeloma Clinical Trial

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

Summary

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. The safety and tolerability of JCARH125 in subjects who receive prophylactic treatment with anakinra will be evaluated in a separate Phase 1 cohort. The antitumor activity of JCARH125 in subjects who have been previously treated with BCMA-directed therapy will be evaluated in separate Phase 2a cohorts.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Diagnosis of multiple myeloma (MM) with relapsed and/or refractory (R/R) 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 (not applicable to Phase 2a):

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 or donor lymphocyte infusion 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 biopsy 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

Phase 2a cohorts only - Subjects with R/R MM who have been previously treated with prior BCMA-directed anti-myeloma therapy, achieved at least a partial response (PR) and progressed on the following treatment:

Subjects who have received prior BCMA-directed CAR T-cell therapy. The last CAR T-cell therapy must have been received at least 6 months prior to JCARH125 screening.
Subjects who have received prior BCMA-directed T-cell engager therapy.
Subjects who have received prior BCMA-directed antibody-drug conjugate therapy.

Exclusion Criteria:

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 plasmaproliferative disorder, 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 (not applicable for subjects enrolled in Phase 2a cohorts)
Prior treatment with a BCMA-targeted agent (not applicable for subjects enrolled in Phase 2a cohorts)
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
Subjects with known hypersensitivity to E Coli-derived proteins (only applicable to subjects in Phase 1 Anakinra Cohort)
History of severe immediate hypersensitivity reaction to any of the protocol-mandated or recommended agents used in this study

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

169

Study ID:

NCT03430011

Recruitment Status:

Active, not recruiting

Sponsor:

Juno Therapeutics, a Subsidiary of Celgene

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There are 23 Locations for this study

See Locations Near You

Local Institution - 0006
Birmingham Alabama, 10016, United States
University of Alabama
Birmingham Alabama, 35294, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
University of California, Los Angeles
Los Angeles California, 90095, United States
University of California
San Francisco California, 94143, United States
Local Institution - 0010
San Francisco California, 94158, United States
SCRI - Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Winship Cancer Institute at Emory University
Atlanta Georgia, 30322, United States
The University of Chicago Medicine
Chicago Illinois, 60637, United States
Kansas University Medical Center
Westwood Kansas, 66205, United States
Local Institution - 0053
Westwood Kansas, 66205, United States
Local Institution - 0009
Baltimore Maryland, 21231, United States
Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Karmanos Cancer Institute Wayne State
Detroit Michigan, 48201, United States
Local Institution - 0062
Detroit Michigan, 48201, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo New York, 14203, United States
Local Institution - 0001
New York New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Oregon Health & Science University
Portland Oregon, 97201, United States
Methodist Hospital
San Antonio Texas, 78229, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Froedtert Hospital Medical College Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

169

Study ID:

NCT03430011

Recruitment Status:

Active, not recruiting

Sponsor:


Juno Therapeutics, a Subsidiary of Celgene

How clear is this clinincal trial information?

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