IRB Study Number 24-725
Status Recruiting
Phase Phase 1
Location U Building - Mellen Center
Institute Neurological Institute
Description
This study aims to evaluate the safety, tolerability, and efficacy of CC-97540 in patients with relapsing or progressive forms of Multiple Sclerosis. It is a Phase 1, multicenter, single-arm, dose-escalation trial. Participants will receive CC-97540 and be monitored for adverse events, disease activity, and drug levels over a period of up to 104 weeks.
There are 3 study periods:
- Pre-treatment Period: Screening, leukapheresis, pre-treatment evaluation
- Treatment Period: Lymphodepleting chemotherapy, CC-97540 infusion, treatment visits (including 2-week hospital stay)
- Post-treatment Period: Follow-up visits up to 24 months post infusion
Inclusion Criteria
Cohort 1: RR or active SPMS
- Age 18-50
- EDSS 3.0-5.5
- In last 12 months while on high-efficacy DMT: clinical relapse OR GdE/new T2 lesion on brain or spinal cord MRI
Cohort 2: PP or inactive SPMS
- Age 18-60
- EDSS 3.0-6.0
- PPMS
- Progressive symptom onset <15 years if EDSS >5.0 or <10 years if EDSS ≤5.0
- Received at least 6 months of ocrelizumab with inadequate response
- iSPMS
- EDSS progression requirements or comparable clinical evidence (≥1 point with EDSS <5.5 or ≥0.5 point with EDSS ≥5.5)
Exclusion Criteria
- Inability to complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds.
- Inability to perform Timed 25-Foot Walk Test (T25FWT) in <150 seconds.
- Presence of active, clinically significant concomitant CNS pathology, other than MS, that may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity
- Any significant acute or chronic medical condition (other than MS), laboratory test result abnormality, or psychiatric illness that would pose a risk to the participant’s safety from participating in the study.
- Active autoimmune disease (other than MS) requiring systemic immunosuppressive therapy.
- Prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for greater than or equal to 2 years.
- Known chronic, active hepatitis B or C virus (HBV/HCV) infection or untreated prior HCV infection (positive HCV IgG result).
- Evidence of active infection by varicella zoster virus, EBV, HSV, HHV, or CMV
- Prior CAR T cell therapy or genetically modified T-cell therapy.
- Stem cell transplant within 1 year prior to Screening.
