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

NCT ID: NCT03486067

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2025-03-18

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Administration of CC-93269

Group Type EXPERIMENTAL

CC-93269

Intervention Type DRUG

Specified dose on specified days

Interventions

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CC-93269

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Alnuctamab

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 105

Birmingham, Alabama, United States

Site Status

Local Institution - 103

San Francisco, California, United States

Site Status

Local Institution - 107

New Haven, Connecticut, United States

Site Status

Local Institution - 106

Atlanta, Georgia, United States

Site Status

Local Institution - 109

Boston, Massachusetts, United States

Site Status

Local Institution - 111

Boston, Massachusetts, United States

Site Status

Henry Ford Medical Center - New Center One

Detroit, Michigan, United States

Site Status

Icahn School of Medicine at Mount Sinai Mount Sinai West

New York, New York, United States

Site Status

Local Institution - 101

Seattle, Washington, United States

Site Status

Local Institution - 305

Erlangen, , Germany

Site Status

Local Institution - 303

Hamburg, , Germany

Site Status

Local Institution - 302

Heidelberg, , Germany

Site Status

Local Institution - 306

München, , Germany

Site Status

Local Institution - 304

Tübingen, , Germany

Site Status

Local Institution - 402

Bergamo, , Italy

Site Status

Local Institution - 403

Meldola, , Italy

Site Status

Local Institution - 401

Milan, , Italy

Site Status

Local Institution - 602

Nagoya, Aichi-ken, Japan

Site Status

Local Institution - 603

Shibuya-ku, Tokyo, Japan

Site Status

Local Institution - 605

Kamakura, , Japan

Site Status

Local Institution - 604

Kashiwa, , Japan

Site Status

Local Institution - 601

Kyoto, , Japan

Site Status

Local Institution - 206

Barcelona, , Spain

Site Status

Local Institution - 208

Barcelona, , Spain

Site Status

Local Institution - 205

Madrid, , Spain

Site Status

Local Institution - 201

Pamplona, , Spain

Site Status

Local Institution - 203

Salamanca, , Spain

Site Status

Local Institution - 204

Santander, , Spain

Site Status

Local Institution - 207

Valencia, , Spain

Site Status

Local Institution - 202

Valencia, , Spain

Site Status

Local Institution - 504

Gothenborg, , Sweden

Site Status

Local Institution - 502

Lund, , Sweden

Site Status

Local Institution - 501

Stockholm, , Sweden

Site Status

Local Institution - 505

Uppsala, , Sweden

Site Status

Countries

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United States Germany Italy Japan Spain Sweden

Related Links

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Other Identifiers

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U1111-1210-6325

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-506564-14

Identifier Type: OTHER

Identifier Source: secondary_id

CC-93269-MM-001

Identifier Type: -

Identifier Source: org_study_id

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