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 |
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Recruitment Status :
Active, not recruiting
First Posted : April 3, 2018
Last Update Posted : November 9, 2022
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: CC-93269 | Phase 1 |
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 2 years or extended up to 5 years for subjects maintaining clinical benefit at the discretion of the Safety Review Committee, until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 220 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
| Experimental: Administration of CC-93269 |
Drug: CC-93269
Specified dose on specified days
Other Name: Alnuctamab |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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
Locations
Show 28 study locations
Sponsors and Collaborators
Celgene
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT03486067 |
| Other Study ID Numbers: |
CC-93269-MM-001 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 |
Keywords provided by Celgene:
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Multiple Myeloma BCMA X CD3 T Cell Antibody CC-93269 Relapsed and Refractory |
Additional relevant MeSH terms:
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |