Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma

Overview

Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.

Full Title of Study: “A Phase 1, Open-label, Dose Finding Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2029

Detailed Description

The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.

Interventions

  • Drug: CC-93269
    • Specified dose on specified days

Arms, Groups and Cohorts

  • Experimental: Administration of CC-93269

Clinical Trial Outcome Measures

Primary Measures

  • Adverse Events (AEs)
    • Time Frame: Up to approximately 63 months
    • Number of participants with Adverse Events
  • Dose Limiting Toxicity (DLT)
    • Time Frame: Up to 60 months
    • Is defined as any of the toxicities occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes.
  • Non-Tolerated Dose (NTD)
    • Time Frame: Up to 60 months
    • Is defined as a dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in the DLT window.
  • Maximum Tolerated Dose (MTD)
    • Time Frame: Up to 60 months
    • Is defined as the last dose cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the DLT window.

Secondary Measures

  • Overall Response Rate (ORR)
    • Time Frame: Up to 60 months
    • Is defined as the proportion of subjects who achieve a partial response or better (eg, PR, VGPR, CR or sCR), according to International Myeloma Working Group (IMWG) response criteria.
  • Time to Response
    • Time Frame: Up to 60 months
    • Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).
  • Duration of Response
    • Time Frame: Up to 60 months
    • Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
  • Progression Free Survival
    • Time Frame: Up to 60 months
    • Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.
  • Overall Survival
    • Time Frame: Up to 60 months
    • Is defined as the time from the first dose of CC-93269 to death from any cause.
  • Pharmacokinetics – Cmax
    • Time Frame: Up to 60 months
    • Maximum serum concentration of drug
  • Pharmacokinetics – Cmin
    • Time Frame: Up to 60 months
    • Minimum serum concentration of drug
  • Pharmacokinetics – AUC
    • Time Frame: Up to 60 months
    • Area under the curve
  • Pharmacokinetics – tmax
    • Time Frame: Up to 60 months
    • Time to peak (maximum) serum concentration
  • Pharmacokinetics – t1/2
    • Time Frame: Up to 60 months
    • Terminal Half-life
  • Pharmacokinetics – CL
    • Time Frame: Up to 60 months
    • Apparent total body clearance
  • Pharmacokinetics – Vss
    • Time Frame: Up to 60 months
    • Volume of distribution at steady-state
  • Pharmacokinetics – accumulation index of alnuctamab
    • Time Frame: Up to 60 months
    • Accumulation ratio of drug
  • Presence and frequency of anti-drug antibodies (ADA)
    • Time Frame: Up to 60 months
    • Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies

Participating in This Clinical Trial

Inclusion Criteria

  • History of multiple myeloma with relapsed and refractory disease – Eastern Cooperative Oncology Group Performance Status of 0 or 1 – Must have measurable disease as determined by the central laboratory Exclusion Criteria:

  • Symptomatic central nervous system involvement of multiple myeloma – Prior autologous stem cell transplant ≤ 3 months prior – Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior – History of concurrent second cancers requiring active, ongoing systemic treatment Other protocol-defined inclusion/exclusion criteria apply

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Celgene
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
  • Overall Contact(s)
    • BMS Study Connect Contact Center www.BMSStudyConnect.com, 855-907-3286, Clinical.Trials@bms.com

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