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Not yet recruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe C-CAR168 is and how well it works for adults with progressive multiple sclerosis (MS) that has not responded well to standard treatment. C-CAR168 uses a person's own immune cells, changed to target certain cells. The study includes MS that worsens from the start and MS that becomes steadily worse after earlier attacks.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can sign and date a form agreeing to join the study.
  • Are 18–55 years old and weigh at least 40 kg (about 88 pounds).
  • Have MS diagnosed using the required medical guidelines.
  • Have the required type of progressive MS: active secondary progressive MS, primary progressive MS, or non-active secondary progressive MS.
  • Have tried at least one highly effective medicine to change the course of MS for at least 6 months, without enough benefit.
  • Have records showing that disability has worsened in the past 24 months.
  • Have a score of 3.0–6.5 on the EDSS, a scale that measures disability from MS.
  • Meet study rules for time with MS, spinal fluid, organ health, heart and lung health, pregnancy testing, birth control, vaccines, and follow-up after cell treatment.

Who can't join

  • Have relapsing-remitting MS, only early symptoms or scan signs of MS, or another condition that better explains the nerve problems.
  • Have another disease that damages the protective covering of nerves, including AQP4-positive NMOSD or MOG-antibody disease.
  • Have an active or long-term infection needing antibiotics, or positive infection tests listed in the study rules.
  • Have not waited long enough after prior MS treatment, or recently had certain treatments that affect the immune system.
  • Have had CAR T-cell therapy, another treatment using genetically changed immune cells, or gene therapy.
  • Are pregnant, breastfeeding, or planning pregnancy during the required follow-up period.
  • Meet any study rule that bars joining because of major heart or blood vessel problems, nerve problems, a transplant, cancer, bleeding or blood clots, allergies, or difficulty following study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

AZ

CA