A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma

Study Purpose

This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in subjects with relapsed and/or refractory multiple myeloma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-98633 to establish a recommended Phase 2 dose (RP2D); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-98633 at the RP2D.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥ 18 years. 2. Signed written informed consent prior to any study procedure. 3. Relapsed and/or refractory multiple myeloma (MM). Subjects must have received at least 3 prior antimyeloma treatment regimens. Subjects must have documented progressive disease during or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry. Also, subjects with documented evidence of progressive disease within the previous 6 months and who are refractory or nonresponsive to their most recent anti-myeloma treatment regimen afterwards will be also eligible. Subjects must have previously received all of the following therapies: 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 combination. 3. Anti-CD38 (eg, daratumumab), either alone or combination. 4. Measurable disease. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Adequate organ function.

Exclusion Criteria:

1. Known active or history of central nervous system (CNS) involvement of MM. 2. Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis. 3. Prior treatment with CAR T-cell or another genetically modified T-cell therapy. 4. Prior treatment with investigational therapy directed at BCMA. 5. Uncontrolled or active infection. 6. Active autoimmune disease requiring immunosuppressive therapy. 7. History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04394650
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Juno Therapeutics, a Subsidiary of Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ashley Koegel, MD
Principal Investigator Affiliation Early Clinical Development
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

Experimental: CC-98633

Subjects will receive CC-98633 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide).

Interventions

Biological: - CC-98633

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce CC 98633. During CC 98633 production, subjects may receive bridging chemotherapy for disease control. Upon successful generation of CC 98633 product, subjects will receive treatment with CC 98633 therapy. Study treatment will include lymphodepleting chemotherapy followed by one dose of CC-98633 administered by intravenous (IV) injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35233

Mayo Clinic, Phoenix, Arizona

Status

Recruiting

Address

Mayo Clinic

Phoenix, Arizona, 85054

Stanford Cancer Center, Stanford, California

Status

Not yet recruiting

Address

Stanford Cancer Center

Stanford, California, 94305

University of Chicago Medicine, Chicago, Illinois

Status

Recruiting

Address

University of Chicago Medicine

Chicago, Illinois, 60637

University of Kansas Hospital, Westwood, Kansas

Status

Recruiting

Address

University of Kansas Hospital

Westwood, Kansas, 66205-2003

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Roswell Park Cancer Institute, Buffalo, New York

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Levine Cancer Institute, Charlotte, North Carolina

Status

Recruiting

Address

Levine Cancer Institute

Charlotte, North Carolina, 28204

UT Southwestern Medical Center, Dallas, Texas

Status

Recruiting

Address

UT Southwestern Medical Center

Dallas, Texas, 75390