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



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/13/2019
Start Date:February 1, 2018
End Date:March 2021
Contact:Juno Medical Information
Email:medicalinformation@junotherapeutics.com
Phone:866-599-JUNO (5866)

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Protocol H125001: An Open-Label Phase 1/2 Study of JCARH125, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, 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 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.


Key Inclusion Criteria:

1. 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:

1. Autologous stem cell transplant

2. A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide,
pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib),
either alone or in combination

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.

2. Subjects must have measurable disease.

3. Subject must be willing to provide fresh bone marrow samples during Screening (and
prior to study treatment, if required).

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 or history of CNS involvement by malignancy

2. 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

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
We found this trial at
10
sites
1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Jonathan Kaufman, MD
Phone: 404-778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Kelvin Lee, MD
Phone: 716-845-4892
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
Principal Investigator: Myo Htut, MD
Phone: 626-218-2405
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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Birmingham, Alabama 35294
Principal Investigator: Luciano Costa, MD, PhD
Phone: 205-996-8023
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Birmingham, AL
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Chicago, Illinois 60637
Principal Investigator: Andrzej Jakubowiak, MD, PhD
Phone: 773-834-1475
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Chicago, IL
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: David Siegel, MD, PhD
Phone: 551-996-5078
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Sham Mailankody, MD
Phone: 212-639-5317
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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San Francisco, California 94143
Principal Investigator: Sandy Wong, MD
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Seattle, Washington 98104
Principal Investigator: William Bensinger, MD
Phone: 206-386-2831
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Seattle, WA
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Westwood, Kansas 66205
Principal Investigator: Siddhartha Ganguly, MD, FACP
Phone: 913-588-7585
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Westwood, KS
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