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Starting soon Phase 1/2

C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Progressive Multiple Sclerosis Refractory to Standard Therapy

NCT07825389 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2027-02
Last updated
2026-10-13

Condition(s) studied

Multiple SclerosisPrimary Progressive Multiple SclerosisSecondary Progress Multiple Sclerosis (SPMS)Primary Progressive Multiple Sclerosis (PPMS)MSMS (Multiple Sclerosis)Neuro-Degenerative DiseaseNeuro-Degenerative DiseasesAutoimmune

Investigational drug(s) / intervention(s)

C-CAR168 →

C-CAR168: Autologous anti-CD20/BCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion following lymphodepleting chemotherapy.

Study summary

This is a global, multicenter, Phase 1b/2 study evaluating the safety and efficacy of C-CAR168, an autologous anti-CD20/BCMA chimeric antigen receptor T-cell therapy, in participants with progressive multiple sclerosis refractory to standard-of-care therapy. The study includes participants with secondary progressive multiple sclerosis (SPMS) and primary progressive multiple sclerosis (PPMS).

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Key Inclusion Criteria: * Able to sign and date the informed consent form. * Male or female, 18-55 years of age, body weight \>=40 kg. * Diagnosis of MS according to the 2024 McDonald criteria with cohort-specific progressive MS requirements. * Cohort 1: active SPMS; Cohort 2: PPMS or non-active SPMS. * Inadequate response to at least one prior high-efficacy disease-modifying therapy administered for at least 6 months. * Documented disability progression over the prior 24 months. * EDSS 3.0 to 6.5, inclusive. * Meets protocol-defined disease-duration, CSF, organ-function, cardiac/pulmonary, pregnancy testing, contraception, vaccination, and cellular-therapy follow-up requirements. Key Exclusion Criteria * RRMS, clinically isolated syndrome, radiologically isolated syndrome, or another diagnosis better explaining the neurologic course. * Alternative inflammatory demyelinating disorders, including AQP4-antibody-positive NMOSD and MOG-antibody-associated disease. * Active or chronic infection requiring antibiotics, or protocol-specified positive infectious disease testing. * Inadequate washout from prior MS therapy or specified recent immunomodulatory treatments. * Prior CAR T-cell therapy, other genetically modified immune cell therapy, or gene therapy. * Pregnant or breastfeeding, or planning pregnancy during the protocol-defined follow-up period. * Specified major cardiovascular, neurologic, transplant, malignancy, bleeding/thromboembolic, allergy, or protocol-compliance exclusions.

Primary outcome measure(s)

  • Incidence and Severity of Treatment-Emergent Adverse Events — Through Month 24
    Incidence and severity of treatment-emergent adverse events, serious adverse events, dose-limiting toxicities, CRS, ICANS, adverse events of special interest, and treatment- or procedure-related adverse events.
  • Proportion of Participants With 6-Month Composite Confirmed Disability Progression (6m-cCDP) Through Month 12 — Through Month 12
    Proportion of participants within each Phase 2 cohort experiencing 6-month composite confirmed disability progression through Month 12

Trial sites (2)

FacilityCityRegionStatus
Research Site Gilbert Arizona
Research Site La Jolla California
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07825389 on ClinicalTrials.gov ↗ ← All trials in the USA