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

NCT04394650 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: CC-98633-MM-001U1111-1251-3435
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 11

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

Keywords

Multiple Myeloma; Myeloma; Myeloma Multiple; CC-98633; BCMA; CAR-T; CART; BCMA CART; BCMA CAR-T

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  incidence and severity of AEs. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

  From the time of informed consent and follow up to 2 years after infusion of CC-98633:

Secondary Outcomes (11)

• Overall Response Rate (ORR)

  Up to 2 years after CC-98633 infusion

• Complete Response (CR) Rate

  Up to 2 years after CC-99633 infusion

• Duration of response (DOR)

  Up to 2 years after CC-98633 infusion

• Time to response (TTR)

  Up to 2 years after CC-98633 infusion

• Time to complete response (TTCR)

  Up to 2 years after CC-98633 infusion

Study Arms (1)

CC-98633

EXPERIMENTAL

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

Biological: CC-98633

Interventions

CC-98633 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.

CC-98633

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Signed written informed consent prior to any study procedure.
• Relapsed and/or refractory multiple myeloma (MM).
• 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.
• Part A and Part B Cohort A: Subjects must have confirmed at least 3 prior antimyeloma treatment regimens.
• 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.
• 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.
• Measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function

You may not qualify if:

• Known active or history of central nervous system (CNS) involvement of MM
• Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis
• Prior treatment with CAR T-cell or another genetically modified T-cell therapy
• Part A and Part B Cohort A only: Prior treatment with investigational therapy directed at BCMA
• Uncontrolled or active infection
• Active autoimmune disease requiring immunosuppressive therapy
• 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

Sponsors & Collaborators

• Juno Therapeutics, a Subsidiary of Celgene: lead

Study Sites (11)

Local Institution - 103

Birmingham, Alabama, 35233, United States

Location

Local Institution - 111

Phoenix, Arizona, 85054, United States

Location

Local Institution - 110

Stanford, California, 94305, United States

Location

Local Institution - 107

Chicago, Illinois, 60637, United States

Location

Local Institution - 101

Westwood, Kansas, 66205-2003, United States

Location

Local Institution - 109

Rochester, Minnesota, 55905, United States

Location

Local Institution - 106

Buffalo, New York, 14263, United States

Location

Local Institution - 104

New York, New York, 10029, United States

Location

Local Institution - 102

New York, New York, 10065, United States

Location

Local Institution - 108

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 105

Dallas, Texas, 75390, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: August 18, 2020
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (11)