Multiple SclerosisPhase 1/2NCT07825389
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Progressive Multiple Sclerosis Refractory to Standard Therapy
A Phase 1/2 study testing C-CAR168 in people with Multiple Sclerosis and Primary Progressive Multiple Sclerosis, run by AbelZeta Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Secondary Progress Multiple Sclerosis (SPMS)
- What is being tested?
- C-CAR168
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2027to Feb 2030
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Research Site
Gilbert, Arizona, 85234
Research Site
La Jolla, California, 92037
About this study
Official 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
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).
- Conditions
- Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Secondary Progress Multiple Sclerosis (SPMS), Primary Progressive Multiple Sclerosis (PPMS), MS, MS (Multiple Sclerosis)
- Being tested
- C-CAR168
- Keywords
- Progressive Multiple Sclerosis, SPMS, PPMS, CAR T-Cell Therapy, C-CAR168, CD20, BCMA, Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis, CAR-T, CAR T cell, CAR T, Autoimmune, neurodegenerative, chimeric antigen receptor T cell, Refractory
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-CAR168Drug
Also called Autologous anti-CD20/BCMA CAR T-cell therapy
Autologous anti-CD20/BCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion following lymphodepleting chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| C-CAR168 | Experimental | Participants will receive:
Leukapheresis Fludarabine Cyclophosphamide Single intravenous infusion of C-CAR168 Receives: Drug: C-CAR168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Treatment-Emergent Adverse Events
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.
Measured: Through Month 24
Proportion of Participants With 6-Month Composite Confirmed Disability Progression (6m-cCDP) Through Month 12
Proportion of participants within each Phase 2 cohort experiencing 6-month composite confirmed disability progression through Month 12
Measured: Through Month 12
Secondary outcomes (13)
Proportion of participants with 6m-cCDP - Through Month 12 (Phase 1b)
Measured: Through Month 12 (Phase 1b)
Proportion of participants with 3m-cCDP
Measured: Through Month 24
Proportion of participants with 6m-cCDP
Measured: Through Month 24
Change from baseline in Expanded Disability Status Scale EDSS)
Measured: Through Month 24
Change from baseline in Functional Systems Score (FSS)
Measured: Through Month 24
Change from baseline in Timed 25-Foot Walk (T25FW)
Measured: Through Month 24
Change from baseline in 9-Hole Peg Test (9-HPT)
Measured: Month 12 and Month 24
Time to first 3m-cCDP
Measured: Through Month 24
Time to first 6m-cCDP
Measured: Through Month 24
MRI lesion changes
Measured: Through Month 24
Incidence and severity of adverse events and serious adverse events
Measured: Through Month 24
Pharmacokinetics of C-CAR168 measured by quantitative polymerase chain reaction (qPCR)
Characterize CAR T-cell expansion and persistence using qPCR
Measured: Through Month 24
Pharmacokinetics of C-CAR168 utilizing flow cytometry
Characterize T-cell expansion and persistence utilizing flow cytometry
Measured: Through Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startFeb 2027 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbelZeta Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yihong Yao, PhD, Study director, AbelZeta Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825389
- Sponsor's protocol ID
- ABZT-412
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made available to other researchers.