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A Study of CC-97540 in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE)

Primary Purpose

Lupus Erythematosus, Systemic

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-97540
Fludarabine
Cyclophosphamide
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring CC-97540, BMS-986353

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of SLE defined as follows: Fulfilling the 2019 ACR/EULAR classification criteria of SLE Presence of anti-dsDNA, anti-histone, anti-chromatin, or anti-Sm antibodies SLE disease activity Active disease at screening, defined as ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ system) ii) Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin. i) Insufficient response is defined as lack of response, insufficient response or lack of sustained response to appropriate doses. Intolerance is not considered insufficient response ii) Methotrexate and azathioprine use will count as 1 for the purposes of the number of failed treatments. Exclusion Criteria: Diagnosis of drug-induced SLE rather than idiopathic SLE Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded Recent or present clinically significant CNS pathology Other protocol-defined Inclusion/Exclusion criteria apply.

Sites / Locations

  • Colorado Blood Cancer InstituteRecruiting
  • Mayo Clinic in Florida
  • Mayo Clinic in Rochester, Minnesota
  • Washington University School of Medicine
  • University Of Nebraska Medical Center
  • Atlantic Health System Overlook Medical CenterRecruiting
  • NYU Langone HealthRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Columbia University Irving Medical CenterRecruiting
  • The University of North Carolina at Chapel Hill
  • Cleveland Clinic
  • The Ohio State University Wexner Medical Center (OSUWMC) - CarePoint East
  • Swedish Medical CenterRecruiting
  • Local Institution - 0019
  • CHU Montpellier Lapeyronie Hospital
  • Hopital Claude Huriez - CHU de Lille
  • Hôpital Saint-Louis
  • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
  • Local Institution - 0025
  • Local Institution - 0017
  • Local Institution - 0012
  • Local Institution - 0023
  • Local Institution - 0014
  • Local Institution - 0013

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of CC-97540

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with treatment-emergent adverse events (AEs)
Number of participants with serious AEs (SAEs)
Number of participants with AEs of special interest (AESI)
Number of participants with laboratory abnormalities
Number of participants with Dose Limiting Toxicities (DLT)
Recommend Phase 2 Dose (RP2D) of CC-97540

Secondary Outcome Measures

Proportion of participants achieving definition of remission in SLE (DORIS) remission
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)
Change in proteinuria measured by urine protein creatinine ratio (UPCR)
Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Proportion of participants achieving DORIS remission over time
Proportion of participants achieving LLDAS over time
Change in Systemic Lupus Erythematosus Disease Activity- 2000 (SLEDAI-2K) over time
Change in proteinuria measured by UPCR over time
Time to the first documentation of DORIS remission
Time to the first documentation of LLDAS
Time from CC-97540 infusion to first disease flare, any flare monitoring by Safety of Estrogens in Lupus Erythematosus National Assessment-SLEDAI (SELENA-SLEDAI)
Maximum observed blood concentration (Cmax)
Time of maximum observed blood concentration (Tmax)
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))

Full Information

First Posted
May 11, 2023
Last Updated
October 17, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05869955
Brief Title
A Study of CC-97540 in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE)
Official Title
A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
February 21, 2028 (Anticipated)
Study Completion Date
February 21, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory Systemic Lupus Erythematosus (SLE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
CC-97540, BMS-986353

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Administration of CC-97540
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CC-97540
Other Intervention Name(s)
BMS-986353
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events (AEs)
Time Frame
Up to 2 years after CC-97540 infusion
Title
Number of participants with serious AEs (SAEs)
Time Frame
Up to 2 years after CC-97540 infusion
Title
Number of participants with AEs of special interest (AESI)
Time Frame
Up to 2 years after CC-97540 infusion
Title
Number of participants with laboratory abnormalities
Time Frame
Up to 2 years after CC-97540 infusion
Title
Number of participants with Dose Limiting Toxicities (DLT)
Time Frame
Up to 2 years after CC-97540 infusion
Title
Recommend Phase 2 Dose (RP2D) of CC-97540
Time Frame
Up to 2 years after CC-97540 infusion
Secondary Outcome Measure Information:
Title
Proportion of participants achieving definition of remission in SLE (DORIS) remission
Time Frame
At week 24
Title
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)
Time Frame
At week 24
Title
Change in proteinuria measured by urine protein creatinine ratio (UPCR)
Time Frame
At week 24
Title
Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame
At week 24
Title
Proportion of participants achieving DORIS remission over time
Time Frame
Up to 2 years
Title
Proportion of participants achieving LLDAS over time
Time Frame
Up to 2 years
Title
Change in Systemic Lupus Erythematosus Disease Activity- 2000 (SLEDAI-2K) over time
Time Frame
Up to 2 years
Title
Change in proteinuria measured by UPCR over time
Time Frame
Up to 2 years
Title
Time to the first documentation of DORIS remission
Time Frame
Up to 2 years
Title
Time to the first documentation of LLDAS
Time Frame
Up to 2 years
Title
Time from CC-97540 infusion to first disease flare, any flare monitoring by Safety of Estrogens in Lupus Erythematosus National Assessment-SLEDAI (SELENA-SLEDAI)
Time Frame
Up to 2 years
Title
Maximum observed blood concentration (Cmax)
Time Frame
Up to 2 years
Title
Time of maximum observed blood concentration (Tmax)
Time Frame
Up to 2 years
Title
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of SLE defined as follows: Fulfilling the 2019 ACR/EULAR classification criteria of SLE Presence of anti-dsDNA, anti-histone, anti-chromatin, or anti-Sm antibodies SLE disease activity Active disease at screening, defined as ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ system) ii) Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin. i) Insufficient response is defined as lack of response, insufficient response or lack of sustained response to appropriate doses. Intolerance is not considered insufficient response ii) Methotrexate and azathioprine use will count as 1 for the purposes of the number of failed treatments. Exclusion Criteria: Diagnosis of drug-induced SLE rather than idiopathic SLE Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded Recent or present clinically significant CNS pathology 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
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Nash, Site 0024
Phone
720-754-4800
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikas Majithia, Site 0006
Phone
904-953-2000
Facility Name
Mayo Clinic in Rochester, Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uma Thanarajasingam, Site 0022
Phone
507-254-2261
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred Kim, Site 0010
Phone
314-326-4785
Facility Name
University Of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Medlin, Site 0028
Phone
402-559-7288
Facility Name
Atlantic Health System Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Kramer, Site 0008
Phone
646-734-2774
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Saxena, Site 0002
Phone
516-205-7051
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margrit Wiesendanger, Site 0011
Phone
646-285-7881
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anca Askanase, Site 0007
Phone
555-555-5555
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saira Sheikh, Site 0003
Phone
919-966-0545
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Littlejohn, Site 0005
Phone
216-445-5559
Facility Name
The Ohio State University Wexner Medical Center (OSUWMC) - CarePoint East
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexa Meara, Site 0027
Phone
111-111-1111
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Mease, Site 0004
Phone
206-386-2000
Facility Name
Local Institution - 0019
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
Facility Name
CHU Montpellier Lapeyronie Hospital
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Morel, Site 0015
Phone
33467338710
Facility Name
Hopital Claude Huriez - CHU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Yakoub-Agha, Site 0016
Phone
+33320444176 ()0 00
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Farge, Site 0018
Phone
33 1 42 49 97 64
Facility Name
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roch Houot, Site 0020
Phone
33299289873
Facility Name
Local Institution - 0025
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0025
Facility Name
Local Institution - 0017
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0012
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0023
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
Facility Name
Local Institution - 0014
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0013
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
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

A Study of CC-97540 in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE)

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