Clinical trial

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

Name
CC-93269-MM-001
Description
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.
Trial arms
Trial start
2018-04-03
Estimated PCD
2029-06-30
Trial end
2029-08-05
Status
Recruiting
Phase
Early phase I
Treatment
CC-93269
Specified dose on specified days
Arms:
Administration of CC-93269
Other names:
Alnuctamab
Size
250
Primary endpoint
Adverse Events (AEs)
Up to approximately 63 months
Dose Limiting Toxicity (DLT)
Up to 60 months
Non-Tolerated Dose (NTD)
Up to 60 months
Maximum Tolerated Dose (MTD)
Up to 60 months
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}
Updated at
2024-04-10

1 organization

1 product

1 indication

Organization
Celgene
Product
CC-93269