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

Multiple Sclerosis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220201
• Other study ID #: CA061-1006
• Status: Recruiting
• Phase: Phase 1
• Start date: March 28, 2024
• Est. completion date: July 15, 2027

Study information

• Verified date: June 2024
• Source: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
• Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: July 15, 2027
• Est. primary completion date: July 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• CC-97540
Specified dose on specified days
• Fludarabine
Specified dose on specified days
• Cyclophosphamide
Specified dose on specified days

Locations

Country	Name	City	State
Belgium	Local Institution - 0017	Gent	Oost-Vlaanderen
France	Local Institution - 0027	Lille	Nord
France	Local Institution - 0013	Paris	Orne
Germany	Local Institution - 0033	Düsseldorf
Germany	Local Institution - 0036	Düsseldorf
Germany	Universitaetsklinikum Erlangen	Erlangen
Germany	Universitaetsklinikum Essen	Essen
Germany	Local Institution - 0024	München
Italy	Local Institution - 0008	Milano	Lombardia
Spain	Hospital Clínic de Barcelona	Barcelona	Catalunya [Cataluña]
Spain	Local Institution - 0016	Barcelona	Barcelona [Barcelona]
Spain	Local Institution - 0034	Barcelona	Barcelona [Barcelona]
Spain	Hospital Universitario Ramón y Cajal	Madrid	Madrid, Comunidad De
Spain	Local Institution - 0019	València
United Kingdom	Local Institution - 0020	London
United Kingdom	Local Institution - 0031	London	London, City Of
United Kingdom	Local Institution - 0018	Manchester
United States	Local Institution - 0023	Aurora	Colorado
United States	Local Institution - 0011	Birmingham	Alabama
United States	Local Institution - 0005	Boston	Massachusetts
United States	Local Institution - 0038	Cincinnati	Ohio
United States	Local Institution - 0001	Cleveland	Ohio
United States	Local Institution - 0006	Dallas	Texas
United States	Local Institution - 0035	Denver	Colorado
United States	Local Institution - 0029	Hackensack	New Jersey
United States	Local Institution - 0028	Irvine	California
United States	Local Institution - 0003	Kansas City	Kansas
United States	Local Institution - 0002	Milwaukee	Wisconsin
United States	Local Institution - 0032	New Haven	Connecticut
United States	Local Institution - 0039	New Orleans	Louisiana
United States	Neurological Institute of New York	New York	New York
United States	Local Institution - 0021	Philadelphia	Pennsylvania
United States	Local Institution - 0037	Portland	Oregon
United States	Local Institution - 0004	Saint Louis	Missouri
United States	Swedish Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company	Celgene Corporation

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)		Up to week 104
Primary	Number of participants with serious adverse events (SAEs)		Up to week 104
Primary	Number of participants with adverse events of special interest (AESIs)		Up to week 104
Primary	Number of participants with laboratory test result abnormalities		Up to week 104
Primary	Number of participants with imaging abnormalities		Up to week 104
Primary	Number of participants with dose-limiting toxicities (DLTs)		Up to week 104
Primary	Recommended Phase 2 dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period		Up to week 104
Secondary	Number of participants meeting no evidence of disease activity (NEDA) criteria		Up to week 104
Secondary	Number of participants with confirmed disability progression per Expanded Disability Status Scale (EDSS)		Up to week 12
Secondary	Annualized relapse rate		Up to week 104
Secondary	Change from baseline in magnetic resonance imaging (MRI) metrics	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
Secondary	Number of participants with disability improvement confirmed per EDSS		Up to week 12
Secondary	Maximum observed blood concentration (Cmax)		Up to week 104
Secondary	Time of maximum observed blood concentration (Tmax)		Up to week 104
Secondary	Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))		Up to week 104
Secondary	Time to last measurable chimeric antigen receptor (CAR T) concentrations (Tlast)		Up to week 104

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting