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

NCT03486067 | Terminated Phase 1 FDA Drug

• 3 other identifiers: CC-93269-MM-001U1111-1210-63252023-506564-14
• Study Type: interventional
• Target: 183
• Locations: 6 countries
• Sites: 34

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; BCMA X CD3 T Cell; Antibody; CC-93269; Relapsed and Refractory

Outcome Measures

Primary Outcomes (4)

• Adverse Events (AEs)

  Number of participants with Adverse Events

  Up to approximately 63 months

• Dose Limiting Toxicity (DLT)

  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.

  Up to 60 months

• Non-Tolerated Dose (NTD)

  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.

  Up to 60 months

• Maximum Tolerated Dose (MTD)

  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.

  Up to 60 months

Secondary Outcomes (14)

• Overall Response Rate (ORR)

  Up to 60 months

• Time to Response

  Up to 60 months

• Duration of Response

  Up to 60 months

• Progression Free Survival

  Up to 60 months

• Overall Survival

  Up to 60 months

Study Arms (1)

Administration of CC-93269

EXPERIMENTAL

Drug: CC-93269

Interventions

CC-93269 DRUG

Specified dose on specified days

Also known as: Alnuctamab

Administration of CC-93269

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (34)

Local Institution - 105

Birmingham, Alabama, 35294, United States

Location

Local Institution - 103

San Francisco, California, 94143, United States

Location

Local Institution - 107

New Haven, Connecticut, 06510, United States

Location

Local Institution - 106

Atlanta, Georgia, 30322, United States

Location

Local Institution - 109

Boston, Massachusetts, 02114, United States

Location

Local Institution - 111

Boston, Massachusetts, 02215, United States

Location

Henry Ford Medical Center - New Center One

Detroit, Michigan, 48202, United States

Location

Icahn School of Medicine at Mount Sinai Mount Sinai West

New York, New York, 10019, United States

Location

Local Institution - 101

Seattle, Washington, 98104, United States

Location

Local Institution - 305

Erlangen, 91054, Germany

Location

Local Institution - 303

Hamburg, 20246, Germany

Location

Local Institution - 302

Heidelberg, 69120, Germany

Location

Local Institution - 306

München, 81675, Germany

Location

Local Institution - 304

Tübingen, 72076, Germany

Location

Local Institution - 402

Bergamo, 24127, Italy

Location

Local Institution - 403

Meldola, 47014, Italy

Location

Local Institution - 401

Milan, 20089, Italy

Location

Local Institution - 602

Nagoya, Aichi-ken, 4678602, Japan

Location

Local Institution - 603

Shibuya-ku, Tokyo, 1508935, Japan

Location

Local Institution - 605

Kamakura, 247-8533, Japan

Location

Local Institution - 604

Kashiwa, 277-8577, Japan

Location

Local Institution - 601

Kyoto, 602-8566, Japan

Location

Local Institution - 206

Barcelona, 08916, Spain

Location

Local Institution - 208

Barcelona, 8035, Spain

Location

Local Institution - 205

Madrid, 28007, Spain

Location

Local Institution - 201

Pamplona, 31008, Spain

Location

Local Institution - 203

Salamanca, 37007, Spain

Location

Local Institution - 204

Santander, 39008, Spain

Location

Local Institution - 207

Valencia, 46009, Spain

Location

Local Institution - 202

Valencia, 46017, Spain

Location

Local Institution - 504

Gothenborg, 413 46, Sweden

Location

Local Institution - 502

Lund, SE-221 85, Sweden

Location

Local Institution - 501

Stockholm, 141 86, Sweden

Location

Local Institution - 505

Uppsala, 75158, Sweden

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 3, 2018
• Study Start: April 3, 2018
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

SE (4); DE (5); IT (3); US (9); ES (8); JP (5)