Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03486067|
Recruitment Status : Active, not recruiting
First Posted : April 3, 2018
Last Update Posted : November 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: CC-93269||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 3, 2018|
|Estimated Primary Completion Date :||July 26, 2027|
|Estimated Study Completion Date :||August 30, 2027|
|Experimental: Administration of CC-93269||
Specified dose on specified days
Other Name: Alnuctamab
- Adverse Events (AEs) [ Time Frame: Up to 60 months ]Number of participants with Adverse Events
- Dose Limiting Toxicity (DLT) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
- Overall Response Rate (ORR) [ Time Frame: 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.
- Time to Response [ Time Frame: 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).
- Duration of Response [ Time Frame: 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.
- Progression Free Survival [ Time Frame: 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 [ Time Frame: Up to 60 months ]Is defined as the time from the first dose of CC-93269 to death from any cause.
- Pharmacokinetics - Cmax [ Time Frame: Up to 60 months ]Maximum serum concentration of drug
- Pharmacokinetics - Cmin [ Time Frame: Up to 60 months ]Minimum serum concentration of drug
- Pharmacokinetics - AUC [ Time Frame: Up to 60 months ]Area under the curve
- Pharmacokinetics - tmax [ Time Frame: Up to 60 months ]Time to peak (maximum) serum concentration
- Pharmacokinetics - t1/2 [ Time Frame: Up to 60 months ]Terminal Half-life
- Pharmacokinetics - CL [ Time Frame: Up to 60 months ]Apparent total body clearance
- Pharmacokinetics - Vss [ Time Frame: Up to 60 months ]Volume of distribution at steady-state
- Pharmacokinetics - accumulation index of alnuctamab [ Time Frame: Up to 60 months ]Accumulation ratio of drug
- Presence and frequency of anti-drug antibodies (ADA) [ Time Frame: Up to 60 months ]Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies
- Evaluate measures of tumor sensitivity/ resistance to CC-93269 [ Time Frame: Up to 60 months ]Measurement of tumor and immune factors
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486067
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|
|Other Study ID Numbers:||
U1111-1210-6325 ( Registry Identifier: WHO )
2017-003448-19 ( EudraCT Number )
|First Posted:||April 3, 2018 Key Record Dates|
|Last Update Posted:||November 9, 2022|
|Last Verified:||November 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
BCMA X CD3 T Cell
Relapsed and Refractory
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases