A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma CC-99712
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What's the purpose of this trial?

Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM). 

This trial is currently open and accepting patients.

What will happen during the trial?

Dose Escalation (Part A)

The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV), to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-99712 using a modified accelerated titration design and Bayesian methodology. The maximum tolerated dose and non-tolerated dose may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules.

Dose Expansion (Part B)

The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 administered at or below the maximum tolerated dose in selected expansion cohorts in order to determine the recommended phase 2 dose (RP2D). One or more dosing regimens may be selected for cohort expansion. All subjects will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or subject/Investigator decision to withdraw.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion

  • Participant is ≥ 18 years of age at the time of signing the ICF.
  • Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease
  • Participant must have measurable disease.
  • Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.

Exclusion Criteria

  • Participant has symptomatic central nervous system involvement of MM.
  • Participant had a prior autologous stem cell transplant ≤ 3 months prior to starting CC-99712.
  • Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-99712 or is on systemic immunosuppression for graft-versus host disease.
  • Subject is a pregnant or lactating female.
  • Subject has known human immunodeficiency virus (HIV) infection.
  • Subject has active hepatitis B or C (HBV/HCV) infection.

Other protocol-defined inclusion/exclusion criteria apply

Additional Trial Information

Phase 1

Enrollment: 160 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Moores Cancer Center UC San Diego Health

La Jolla, CA

Open and Accepting

Florida

Florida Cancer Specialists Sarasota Cattlemen

Sarasota, FL

Open and Accepting

New York

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Oregon

Oregon Health and Science University (OHSU) Knight Cancer Institute

Portland, OR

Open and Accepting

Texas

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Open and Accepting

Washington

Swedish - Cherry Hill Campus Cherry Hill Campus

Seattle, WA

Open and Accepting
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