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

Celgene

Status and phase: Active, not recruiting; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: CC-93269

Study type: Interventional

Funder types: Industry

Identifiers

NCT03486067

U1111-1210-6325 (Registry Identifier)

CC-93269-MM-001

2017-003448-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Administration of CC-93269

Experimental group

Treatment:

Drug: CC-93269