Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma
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What's the purpose of this trial?

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

The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered intravenously (IV), to determine the MTD and NTD of both the first dose and subsequent doses of CC-93269. The expansion part (Part B) will further evaluate the safety and efficacy of CC-93269 administered IV at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the RP2D. CC-93269, administered IV followed by subcutaneously (SC), will also be evaluated (Part C). One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 2 years until confirmed disease progression, unacceptable toxicity, or subject/Investigator decision to withdraw.

This trial is currently open and accepting patients.

What will happen during the trial?

Additional Trial Information

Phase 1

Enrollment: 175 patients (estimated)

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Published Results

Interim results from the first study of CC-93269 in patients with relapsed/refractory multiple myeloma

January 22, 2020

  • The overall response rate (ORR) in all patients was 43.3% with a stringent complete response/complete response (sCR/CR) of 16.7%
  • The likelihood of response was dose-dependent. ORR by CC-93269 dose:
    • Dose ≤ 3mg (n= 7): 0%
    • Dose 3 to 6 mg or fixed-dose 6 mg (n= 14): 7%
    • Dose 6 to 10 mg or fixed-dose 10 mg (n= 9): 88.9%
  • Among the nine patients treated with 10 mg of CC-93269, the ORR was 88.9% with a sCR/CR of 44.4%
  • The median time to response was 4.1 weeks (range; 4–13.1)
  • Among 13 responding patients, 11 responses are ongoing
  • Measurable residual disease (MRD) negativity was achieved by 12 of the 13 responding patients
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Trial Locations

All Trial Locations

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Alabama

UAB Comprehensive Cancer Center University of Alabama at Birmingham

Birmingham, AL

Open and Accepting

California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco

San Francisco, CA

Open and Accepting

Connecticut

Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven

New Haven, CT

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

New York

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Washington

Swedish Cancer Institute Cherry Hill Campus

Seattle, WA

Open and Accepting
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