A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma

A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma

A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

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). The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV) in monotherapy (Arm 1) or combination with BMS-986405 (Arm 2), to determine the maximum tolerated dose (MTD) of CC-99712 guided by a Bayesian logistic regression model (BLRM). A modified accelerated titration design will also be used for Arm 1 and Arm 2. The MTD may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules. The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 in monotherapy (Arm 1) or combination (Arm 2) administered at or below the MTD in selected expansion cohorts in order to determine the RP2D. One or more doses or dosing regimens may be selected for cohort expansion. All participants will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or participants//Investigator decision to withdraw.

Is defined as the highest dose that causes DLTs in no more than 33% of patient population during the first cycle of treatment.

Is defined as the proportion of participants who achieve a partial response or better (eg, Partial response (PR), Very good partial response (VGPR), Complete response (CR) or sCR), according to IMWG response criteria.

Is defined as the time from the first CC-99712 dose date to the date of first documented response (PR or better).

Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.

Is defined as the time from the first dose of CC-99712 to progressive disease (PD) or death from any cause, whichever occurs first.

Presence and frequency of ADA using a validated bridging immunoassay with electrochemiluminescence detection

Participants must satisfy the following criteria to be enrolled in the study: 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

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