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

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 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.

Study Overview

• Status: Terminated
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: CC-93269

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.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Local Institution - 305
  • Hamburg, Germany, 20246
    • Local Institution - 303
  • Heidelberg, Germany, 69120
    • Local Institution - 302
  • München, Germany, 81675
    • Local Institution - 306
  • Tuebingen, Germany, 72076
    • Local Institution - 304
• Italy
  • Bergamo, Italy, 24127
    • Local Institution - 402
  • Meldola, Italy, 47014
    • Local Institution - 403
  • Milan, Italy, 20089
    • Local Institution - 401
• Japan
  • Kamakura, Japan, 247-8533
    • Local Institution - 605
  • Kashiwa, Japan, 277-8577
    • Local Institution - 604
  • Kyoto, Japan, 602-8566
    • Local Institution - 601
  • Aichi
    • Nagoya-shi, Aichi, Japan, 4678602
      • Local Institution - 602
  • Tokyo
    • Shibuya-ku, Tokyo, Japan, 1508935
      • Local Institution - 603
• Spain
  • Barcelona, Spain, 08916
    • Local Institution - 206
  • Barcelona, Spain, 8035
    • Local Institution - 208
  • Madrid, Spain, 28007
    • Local Institution - 205
  • Pamplona, Spain, 31008
    • Local Institution - 201
  • Salamanca, Spain, 37007
    • Local Institution - 203
  • Santander, Spain, 39008
    • Local Institution - 204
  • Valencia, Spain, 46009
    • Local Institution - 207
  • Valencia, Spain, 46017
    • Local Institution - 202
• Sweden
  • Gothenborg, Sweden, 413 46
    • Local Institution - 504
  • Lund, Sweden, SE-221 85
    • Local Institution - 502
  • Stockholm, Sweden, 141 86
    • Local Institution - 501
  • Uppsala, Sweden, 75158
    • Local Institution - 505
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Local Institution - 105
  • California
    • San Francisco, California, United States, 94143
      • Local Institution - 103
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Local Institution - 107
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Local Institution - 106
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Local Institution - 109
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 111
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center - New Center One
  • New York
    • New York, New York, United States, 10019
      • Icahn School of Medicine at Mount Sinai Mount Sinai West
  • Washington
    • Seattle, Washington, United States, 98104
      • Local Institution - 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of CC-93269	Drug: CC-93269; Specified dose on specified days; Other Names: Alnuctamab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicity (DLT)	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.	Up to 60 months
Non-Tolerated Dose (NTD)	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.	Up to 60 months
Maximum Tolerated Dose (MTD)	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.	Up to 60 months
Adverse Events (AEs)	Number of participants with Adverse Events	Up to approximately 63 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): March 18, 2025
• Study Completion (Actual): March 18, 2025

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Antibody; Relapsed and Refractory; BCMA X CD3 T Cell; CC-93269
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CC-93269-MM-001; U1111-1210-6325 (Registry Identifier: WHO); 2023-506564-14 (Other Identifier: EU CTR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No