A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis or Progressive Forms of Multiple Sclerosis

May 7, 2024 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants With Relapsing Forms of Multiple Sclerosis (RMS) or Progressive Forms of Multiple Sclerosis (PMS)

The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS) or Progressive Forms of Multiple Sclerosis (PMS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain the NCT# and Site#

Study Contact Backup

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
  • France
    • Nord
      • Lille, Nord, France, 59000
        • Not yet recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
    • Orne
      • Paris, Orne, France, 75013
        • Not yet recruiting
        • Local Institution - 0013
        • Contact:
          • Site 0013
  • Germany
      • Düsseldorf, Germany, 40225
        • Not yet recruiting
        • Local Institution - 0033
        • Contact:
          • Site 0033
      • Düsseldorf, Germany, 40225
        • Withdrawn
        • Local Institution - 0036
      • Erlangen, Germany, 91054
        • Not yet recruiting
        • Local Institution - 0022
        • Contact:
          • Site 0022
      • Essen, Germany, 45122
        • Not yet recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
      • München, Germany, 81337
        • Not yet recruiting
        • Local Institution - 0024
        • Contact:
          • Site 0024
  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Withdrawn
        • Local Institution - 0008
  • Spain
      • València, Spain, 46026
        • Not yet recruiting
        • Local Institution - 0019
        • Contact:
          • Site 0019
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Not yet recruiting
        • Local Institution - 0016
        • Contact:
          • Site 0016
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Not yet recruiting
        • Local Institution - 0034
        • Contact:
          • Site 0034
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Not yet recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Not yet recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015
  • United Kingdom
      • London, United Kingdom, E1 1RD
        • Not yet recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
      • Manchester, United Kingdom, M13 9WL
        • Not yet recruiting
        • Local Institution - 0018
        • Contact:
          • Site 0018
    • London, City Of
      • London, London, City Of, United Kingdom, NW1 2PG
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Not yet recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011
    • California
      • Irvine, California, United States, 92697
        • Not yet recruiting
        • Local Institution - 0028
        • Contact:
          • Site 0028
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Local Institution - 0023
        • Contact:
          • Site 0023
      • Denver, Colorado, United States, 80218
        • Not yet recruiting
        • Local Institution - 0035
        • Contact:
          • Site 0035
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Not yet recruiting
        • Local Institution - 0032
        • Contact:
          • Site 0032
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • Local Institution - 0003
        • Contact:
          • Site 0003
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Not yet recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Local Institution - 0005
        • Contact:
          • Site 0005
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Local Institution - 0004
        • Contact:
          • Site 0004
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
    • New York
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Not yet recruiting
        • Local Institution - 0038
        • Contact:
          • Site 0038
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Local Institution - 0037
        • Contact:
          • Site 0037
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
    • Texas
      • Dallas, Texas, United States, 75390
        • Not yet recruiting
        • Local Institution - 0006
        • Contact:
          • Site 0006
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
        • Contact:
          • Pavle Repovic, Site 0007
          • Phone Number: 206-320-2200
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Local Institution - 0002
        • Contact:
          • Site 0002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

- Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1.

i) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5.

ii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed/refractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months.

- Progressive forms of MS - Cohort 2.

i) Participants must have an EDSS ≥ 3.0 and ≤ 6.0.

ii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS).

Exclusion Criteria

  • Participants that cannot complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds.
  • Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds.
  • Participants must not have MS lesions or symptoms that may place patients at increased risk of neurotoxicity, including, but not limited to, tumefactive lesion (3 cm or greater within 5 years prior to Screening) or decreased level of consciousness, and/or presence of active, clinically significant concomitant central nervous system pathology other than MS that may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Administration of CC-97540 (RMS arm)
Drug: Cyclophosphamide
Specified dose on specified days
Drug: Fludarabine
Specified dose on specified days
Drug: CC-97540
Specified dose on specified days
Other Names:
  • BMS-986353
Experimental: Administration of CC-97540 (PMS arm)
Drug: Cyclophosphamide
Specified dose on specified days
Drug: Fludarabine
Specified dose on specified days
Drug: CC-97540
Specified dose on specified days
Other Names:
  • BMS-986353

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to week 104
Up to week 104
Number of participants with serious adverse events (SAEs)
Time Frame: Up to week 104
Up to week 104
Number of participants with adverse events of special interest (AESIs)
Time Frame: Up to week 104
Up to week 104
Number of participants with laboratory test result abnormalities
Time Frame: Up to week 104
Up to week 104
Number of participants with imaging abnormalities
Time Frame: Up to week 104
Up to week 104
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: Up to week 104
Up to week 104
Recommended Phase 2 dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period
Time Frame: Up to week 104
Up to week 104

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants meeting no evidence of disease activity (NEDA) criteria
Time Frame: Up to week 104
Up to week 104
Number of participants with confirmed disability progression per Expanded Disability Status Scale (EDSS)
Time Frame: Up to week 12
Up to week 12
Annualized relapse rate
Time Frame: Up to week 104
Up to week 104
Change from baseline in magnetic resonance imaging (MRI) metrics
Time Frame: Up to week 104
MRI metrics assessed are 1) number of gadolinium-enhancing T1 lesions and 2) total number of new or enlarging hyperintense T2-weigted lesions
Up to week 104
Number of participants with disability improvement confirmed per EDSS
Time Frame: Up to week 12
Up to week 12
Maximum observed blood concentration (Cmax)
Time Frame: Up to week 104
Up to week 104
Time of maximum observed blood concentration (Tmax)
Time Frame: Up to week 104
Up to week 104
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Time Frame: Up to week 104
Up to week 104
Time to last measurable chimeric antigen receptor (CAR T) concentrations (Tlast)
Time Frame: Up to week 104
Up to week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Collaborators

Celgene Corporation

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2024

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

July 15, 2027

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA061-1006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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-andresearch/disclosure-commitment.html

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Cyclophosphamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe