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NCT Number: NCT07825389

A Study of C-CAR168 in Participants With Progressive Multiple Sclerosis

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

C-CAR168

Drug

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

Other names: Autologous anti-CD20/BCMA CAR T-cell therapy

Primary outcomes

  1. Incidence and Severity of Treatment-Emergent Adverse Events

    Time frame: 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.

  2. Proportion of Participants With 6-Month Composite Confirmed Disability Progression (6m-cCDP) Through Month 12

    Time frame: Through Month 12

    Proportion of participants within each Phase 2 cohort experiencing 6-month composite confirmed disability progression through Month 12

Secondary outcomes

  1. Proportion of participants with 6m-cCDP - Through Month 12 (Phase 1b)

    Time frame: Through Month 12 (Phase 1b)

  2. Proportion of participants with 3m-cCDP

    Time frame: Through Month 24

  3. Proportion of participants with 6m-cCDP

    Time frame: Through Month 24

  4. Change from baseline in Expanded Disability Status Scale EDSS)

    Time frame: Through Month 24

  5. Change from baseline in Functional Systems Score (FSS)

    Time frame: Through Month 24

  6. Change from baseline in Timed 25-Foot Walk (T25FW)

    Time frame: Through Month 24

  7. Change from baseline in 9-Hole Peg Test (9-HPT)

    Time frame: Month 12 and Month 24

  8. Time to first 3m-cCDP

    Time frame: Through Month 24

  9. Time to first 6m-cCDP

    Time frame: Through Month 24

  10. MRI lesion changes

    Time frame: Through Month 24

  11. Incidence and severity of adverse events and serious adverse events

    Time frame: Through Month 24

  12. Pharmacokinetics of C-CAR168 measured by quantitative polymerase chain reaction (qPCR)

    Time frame: Through Month 24

    Characterize CAR T-cell expansion and persistence using qPCR

  13. Pharmacokinetics of C-CAR168 utilizing flow cytometry

    Time frame: Through Month 24

    Characterize T-cell expansion and persistence utilizing flow cytometry

Study contacts

Contact information is provided by the study sponsor or research team.

Kirstin Liechty

CONTACT

[email protected]

240-552-5870

Nurat Quadri

CONTACT

[email protected]

1 240 552 5870

Sponsors and collaborators

Lead sponsor

AbelZeta Inc.

Industry

Registry information

Official study title

Multi-center, Phase 1b/2 Clinical Study of an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy (C-CAR168) for the Treatment of Progressive Multiple Sclerosis Refractory to Standard Therapy

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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