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

NCT ID: NCT04394650

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-18
• Study Completion Date: 2024-07-03

Brief Summary

This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in participants 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(s); 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(s).

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CC-98633

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

Group Type: EXPERIMENTAL

CC-98633

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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).

1. Subjects must have documented progressive disease as per International Myeloma Working Group (IMWG) criteria during or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry. Also, subjects with confirmed progressive disease within 6 months prior to start of Screening and who are refractory (or non-responsive) to their most recent anti-myeloma treatment regimen afterwards will be also eligible.

2. Part A and Part B Cohort A: Subjects must have confirmed at least 3 prior antimyeloma treatment regimens.

3. Part B Cohort B only: Subjects must have received at least 1 but no greater than 3 prior antimyeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent.

4. Subjects must have previously received all of the following therapies:

i) Autologous stem cell transplant ii) A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination iii) Anti-CD38 (eg, daratumumab), either alone or combination Subjects in Cohort B do not require prior anti-CD38 antibody therapy.

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. Part A and Part B Cohort A only: 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juno Therapeutics, a Subsidiary of Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 103

Birmingham, Alabama, United States

Local Institution - 111

Phoenix, Arizona, United States

Local Institution - 110

Stanford, California, United States

Local Institution - 107

Chicago, Illinois, United States

Local Institution - 101

Westwood, Kansas, United States

Local Institution - 109

Rochester, Minnesota, United States

Local Institution - 106

Buffalo, New York, United States

Local Institution - 104

New York, New York, United States

Local Institution - 102

New York, New York, United States

Local Institution - 108

Charlotte, North Carolina, United States

Local Institution - 105

Dallas, Texas, United States

Countries

United States

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT04394650.html

BMS Clinical Trial Patient Recruiting

Other Identifiers

U1111-1251-3435

Identifier Type: OTHER

Identifier Source: secondary_id

CC-98633-MM-001

Identifier Type: -

Identifier Source: org_study_id