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

J

Juno Therapeutics

Status and phase

Enrolling
Phase 1

Conditions

Multiple Sclerosis

Treatments

Drug: Cyclophosphamide
Drug: CC-97540
Drug: Fludarabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06220201
CA061-1006

Details and patient eligibility

About

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).

Enrollment

98 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

98 participants in 2 patient groups

Administration of CC-97540 (RMS arm)
Experimental group
Treatment:
Drug: Fludarabine
Drug: CC-97540
Drug: Cyclophosphamide
Administration of CC-97540 (PMS arm)
Experimental group
Treatment:
Drug: Fludarabine
Drug: CC-97540
Drug: Cyclophosphamide

Trial contacts and locations

35

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Central trial contact

BMS Study Connect www.BMSStudyConnect.com; First line of the email MUST contain the NCT# and Site#

Data sourced from clinicaltrials.gov

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