Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma
- Registration Number
- NCT03486067
- Lead Sponsor
- Celgene
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 183
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of CC-93269 CC-93269 -
- Primary Outcome Measures
Name Time Method Adverse Events (AEs) Up to approximately 63 months Number of participants with Adverse Events
Dose Limiting Toxicity (DLT) Up to 60 months 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.
Non-Tolerated Dose (NTD) Up to 60 months 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.
Maximum Tolerated Dose (MTD) Up to 60 months 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.
- Secondary Outcome Measures
Name Time Method Duration of Response Up to 60 months Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
Time to Response Up to 60 months Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).
Overall Response Rate (ORR) Up to 60 months 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.
Progression Free Survival Up to 60 months Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.
Overall Survival Up to 60 months Is defined as the time from the first dose of CC-93269 to death from any cause.
Pharmacokinetics - Cmax Up to 60 months Maximum serum concentration of drug
Pharmacokinetics - Cmin Up to 60 months Minimum serum concentration of drug
Pharmacokinetics - AUC Up to 60 months Area under the curve
Pharmacokinetics - tmax Up to 60 months Time to peak (maximum) serum concentration
Pharmacokinetics - t1/2 Up to 60 months Terminal Half-life
Pharmacokinetics - CL Up to 60 months Apparent total body clearance
Pharmacokinetics - Vss Up to 60 months Volume of distribution at steady-state
Pharmacokinetics - accumulation index of alnuctamab Up to 60 months Accumulation ratio of drug
Presence and frequency of anti-drug antibodies (ADA) Up to 60 months Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies
Trial Locations
- Locations (34)
Local Institution - 106
🇺🇸Atlanta, Georgia, United States
Local Institution - 111
🇺🇸Boston, Massachusetts, United States
Local Institution - 101
🇺🇸Seattle, Washington, United States
Local Institution - 603
🇯🇵Shibuya-ku, Tokyo, Japan
Local Institution - 602
🇯🇵Nagoya-shi, Aichi, Japan
Local Institution - 109
🇺🇸Boston, Massachusetts, United States
Local Institution - 107
🇺🇸New Haven, Connecticut, United States
Local Institution - 105
🇺🇸Birmingham, Alabama, United States
Icahn School of Medicine at Mount Sinai Mount Sinai West
🇺🇸New York, New York, United States
Local Institution - 302
🇩🇪Heidelberg, Germany
Local Institution - 305
🇩🇪Erlangen, Germany
Local Institution - 306
🇩🇪München, Germany
Local Institution - 401
🇮🇹Milan, Italy
Local Institution - 402
🇮🇹Bergamo, Italy
Local Institution - 304
🇩🇪Tuebingen, Germany
Local Institution - 206
🇪🇸Barcelona, Spain
Local Institution - 604
🇯🇵Kashiwa, Japan
Local Institution - 605
🇯🇵Kamakura, Japan
Local Institution - 205
🇪🇸Madrid, Spain
Local Institution - 208
🇪🇸Barcelona, Spain
Local Institution - 207
🇪🇸Valencia, Spain
Local Institution - 504
🇸🇪Gothenborg, Sweden
Local Institution - 202
🇪🇸Valencia, Spain
Local Institution - 505
🇸🇪Uppsala, Sweden
Local Institution - 501
🇸🇪Stockholm, Sweden
Local Institution - 103
🇺🇸San Francisco, California, United States
Local Institution - 203
🇪🇸Salamanca, Spain
Henry Ford Medical Center - New Center One
🇺🇸Detroit, Michigan, United States
Local Institution - 303
🇩🇪Hamburg, Germany
Local Institution - 403
🇮🇹Meldola, Italy
Local Institution - 201
🇪🇸Pamplona, Spain
Local Institution - 601
🇯🇵Kyoto, Japan
Local Institution - 204
🇪🇸Santander, Spain
Local Institution - 502
🇸🇪Lund, Sweden