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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: CC-93269


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of CC-93269<br> | Drug: CC-93269<br>* Specified dose on specified days<br>* Other names: Alnuctamab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Number of participants with Adverse Events | Up to approximately 63 months | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 - AUC | Area under the curve | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, BCMA X CD3 T Cell, Antibody, CC-93269, Relapsed and Refractory