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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-93269
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, BCMA X CD3 T Cell, Antibody, CC-93269, Relapsed and Refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • University Of California San Francisco Medical CenterRecruiting
  • Yale Cancer CenterRecruiting
  • Winship Cancer Institute of Emory UniversityRecruiting
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Henry Ford Medical Center - New Center One
  • Icahn School of Medicine at Mount Sinai Mount Sinai West
  • Swedish Cancer InstituteRecruiting
  • Local Institution - 305Recruiting
  • Local Institution - 303Recruiting
  • Local Institution - 302Recruiting
  • Local Institution - 0506
  • Local Institution - 0507
  • Local Institution - 306Recruiting
  • Local Institution - 304Recruiting
  • Local Institution - 402Recruiting
  • Local Institution - 403Recruiting
  • Local Institution - 401Recruiting
  • Local Institution - 602
  • Local Institution - 603Recruiting
  • Local Institution - 604
  • Local Institution - 601
  • Local Institution - 206Recruiting
  • Local Institution - 208Recruiting
  • Local Institution - 205Recruiting
  • Local Institution - 201Recruiting
  • Local Institution - 203Recruiting
  • Local Institution - 204Recruiting
  • Local Institution - 207Recruiting
  • Local Institution - 202Recruiting
  • Local Institution - 504Recruiting
  • Local Institution - 502Recruiting
  • Local Institution - 501Recruiting
  • Local Institution - 505Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of CC-93269

Arm Description

Outcomes

Primary Outcome Measures

Adverse Events (AEs)
Number of participants with Adverse Events
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.
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.
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.

Secondary Outcome Measures

Overall Response Rate (ORR)
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
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
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
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
Is defined as the time from the first dose of CC-93269 to death from any cause.
Pharmacokinetics - Cmax
Maximum serum concentration of drug
Pharmacokinetics - Cmin
Minimum serum concentration of drug
Pharmacokinetics - AUC
Area under the curve
Pharmacokinetics - tmax
Time to peak (maximum) serum concentration
Pharmacokinetics - t1/2
Terminal Half-life
Pharmacokinetics - CL
Apparent total body clearance
Pharmacokinetics - Vss
Volume of distribution at steady-state
Pharmacokinetics - accumulation index of alnuctamab
Accumulation ratio of drug
Presence and frequency of anti-drug antibodies (ADA)
Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies
Evaluate measures of tumor sensitivity/ resistance to CC-93269
Measurement of tumor and immune factors

Full Information

First Posted
March 21, 2018
Last Updated
September 27, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT03486067
Brief Title
Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
July 26, 2027 (Anticipated)
Study Completion Date
August 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, BCMA X CD3 T Cell, Antibody, CC-93269, Relapsed and Refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of CC-93269
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CC-93269
Other Intervention Name(s)
Alnuctamab
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
Number of participants with Adverse Events
Time Frame
Up to 60 months
Title
Dose Limiting Toxicity (DLT)
Description
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.
Time Frame
Up to 60 months
Title
Non-Tolerated Dose (NTD)
Description
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.
Time Frame
Up to 60 months
Title
Maximum Tolerated Dose (MTD)
Description
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.
Time Frame
Up to 60 months
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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 Frame
Up to 60 months
Title
Time to Response
Description
Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).
Time Frame
Up to 60 months
Title
Duration of Response
Description
Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
Time Frame
Up to 60 months
Title
Progression Free Survival
Description
Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.
Time Frame
Up to 60 months
Title
Overall Survival
Description
Is defined as the time from the first dose of CC-93269 to death from any cause.
Time Frame
Up to 60 months
Title
Pharmacokinetics - Cmax
Description
Maximum serum concentration of drug
Time Frame
Up to 60 months
Title
Pharmacokinetics - Cmin
Description
Minimum serum concentration of drug
Time Frame
Up to 60 months
Title
Pharmacokinetics - AUC
Description
Area under the curve
Time Frame
Up to 60 months
Title
Pharmacokinetics - tmax
Description
Time to peak (maximum) serum concentration
Time Frame
Up to 60 months
Title
Pharmacokinetics - t1/2
Description
Terminal Half-life
Time Frame
Up to 60 months
Title
Pharmacokinetics - CL
Description
Apparent total body clearance
Time Frame
Up to 60 months
Title
Pharmacokinetics - Vss
Description
Volume of distribution at steady-state
Time Frame
Up to 60 months
Title
Pharmacokinetics - accumulation index of alnuctamab
Description
Accumulation ratio of drug
Time Frame
Up to 60 months
Title
Presence and frequency of anti-drug antibodies (ADA)
Description
Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies
Time Frame
Up to 60 months
Title
Evaluate measures of tumor sensitivity/ resistance to CC-93269
Description
Measurement of tumor and immune factors
Time Frame
Up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciano Costa, Site 105
Phone
205-934-9695
Facility Name
University Of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Wong, Site 103
Phone
415-353-8363
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noffar Bar, Site 107
Phone
000-000-0000
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Hofmeister, Site 106
Phone
404-778-8580
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Yee, Site 109
Phone
617-632-2104
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacalyn Rosenblatt, Site 111
Phone
617-667-9920
Facility Name
Henry Ford Medical Center - New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Completed
Facility Name
Icahn School of Medicine at Mount Sinai Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Completed
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swathi Namburi, Site 101
Facility Name
Local Institution - 305
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 305
Facility Name
Local Institution - 303
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 303
Facility Name
Local Institution - 302
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 302
Facility Name
Local Institution - 0506
City
Munich
ZIP/Postal Code
81829
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0507
City
Munich
ZIP/Postal Code
81829
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Local Institution - 306
City
München
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 306
Facility Name
Local Institution - 304
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 304
Facility Name
Local Institution - 402
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 402
Facility Name
Local Institution - 403
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 403
Facility Name
Local Institution - 401
City
Milan
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 401
Facility Name
Local Institution - 602
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4678602
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 602
Facility Name
Local Institution - 603
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
1508935
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 603
Facility Name
Local Institution - 604
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 604
Facility Name
Local Institution - 601
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 601
Facility Name
Local Institution - 206
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 206
Facility Name
Local Institution - 208
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 208
Facility Name
Local Institution - 205
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 205
Facility Name
Local Institution - 201
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 201
Facility Name
Local Institution - 203
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 203
Facility Name
Local Institution - 204
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 204
Facility Name
Local Institution - 207
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 207
Facility Name
Local Institution - 202
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 202
Facility Name
Local Institution - 504
City
Gothenborg
ZIP/Postal Code
413 46
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 504
Facility Name
Local Institution - 502
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 502
Facility Name
Local Institution - 501
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 501
Facility Name
Local Institution - 505
City
Uppsala
ZIP/Postal Code
75158
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 505

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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