ClinicalTrials.gg
Not yet recruitingNCT07825389Updated Oct 13, 2026

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 interventional study of C-CAR168 in Multiple Sclerosis, Primary Progressive Multiple Sclerosis and Secondary Progress Multiple Sclerosis (SPMS), sponsored by AbelZeta Inc.. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Primary conditionMultiple Sclerosis, Chronic ProgressiveRegistry: Multiple SclerosisReclassifiedWhy we changed it
Registry
Multiple Sclerosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Multiple Sclerosis, Chronic Progressive
Why
  1. The study's listed conditions name Multiple Sclerosis, Chronic Progressive, a narrower term within Multiple Sclerosis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by AbelZeta Inc. · Phase 1/2, Interventional, and Treatment

Updated Oct 13, 2026First site in United StatesStudy contact changed+2 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
119
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

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).

02

Conditions studied

  • Multiple Sclerosis
  • Primary Progressive Multiple Sclerosis
  • Secondary Progress Multiple Sclerosis (SPMS)
  • Primary Progressive Multiple Sclerosis (PPMS)
  • MS
  • MS (Multiple Sclerosis)
  • Neuro-Degenerative Disease
  • Neuro-Degenerative Diseases
  • Autoimmune

Browse trials for

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
03

In context

Multiple Sclerosis, Chronic Progressive Reclassified

244 studies on the registry are indexed under Multiple Sclerosis, Chronic Progressive; 53 are open to participants now.

This study's planned enrollment of 119 is above the median of 54 across 189 interventional studies indexed under Multiple Sclerosis, Chronic Progressive.

Browse Multiple Sclerosis, Chronic Progressive studies →

Lead sponsor

AbelZeta Inc. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Compared within Multiple Sclerosis, Chronic Progressive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Multiple Sclerosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Able to sign and date the 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, , 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, , bleeding/thromboembolic, allergy, or protocol-compliance exclusions.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
119 participants (estimated)

Study arms

  • Experimental
    C-CAR168

    Participants will receive: Leukapheresis Fludarabine Cyclophosphamide Single intravenous infusion of C-CAR168

    Drug: C-CAR168

Interventions

  • DrugC-CAR168

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

    Also known as: Autologous anti-CD20/BCMA CAR T-cell therapy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through Month 24

  2. 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

    Time frame: 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)

    Characterize CAR T-cell expansion and persistence using qPCR

    Time frame: Through Month 24

  13. Pharmacokinetics of C-CAR168 utilizing flow cytometry

    Characterize T-cell expansion and persistence utilizing flow cytometry

    Time frame: Through Month 24

07

Study locations

2 sites
  • Research Site
    Gilbert, Arizona 85234, United States
  • Research Site
    La Jolla, California 92037, United States
08

References and documents

Individual participant data

Plan to share: No — Individual participant data collected during this study will not be made available to other researchers.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2027; primary completion for Feb 2030, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 17, 2026
StartEst.
Feb 2027
Primary completionEst.
Feb 2030
CompletionEst.
Feb 2030
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added — first site in United States
Show 2 added (2 United States)
  • Research Site · Gilbert, United States
  • Research Site · La Jolla, United States
Oct 13, 2026
Contact
Study contact changed: k•••@abelzeta.com · •••5870→k•••@abelzeta.com · •••5870; c•••@abelzeta.com · •••5870→c•••@abelzeta.com · •••5870. See the current contact
Oct 13, 2026
Title
A Study of C-CAR168 in Participants With Progressive Multiple Sclerosis→C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Progressive Multiple Sclerosis Refractory to Standard Therapy
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    2 sites added — first site in United States
    Show 2 added (2 United States)
    • Research Site · Gilbert, United States
    • Research Site · La Jolla, United States
    Contact Study contact changed: k•••@abelzeta.com · •••5870→k•••@abelzeta.com · •••5870; c•••@abelzeta.com · •••5870→c•••@abelzeta.com · •••5870. See the current contact
    Title A Study of C-CAR168 in Participants With Progressive Multiple Sclerosis→C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Progressive Multiple Sclerosis Refractory to Standard Therapy
    + 3 other changes: verification date, oversight details and conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07825389
Lead sponsor
AbelZeta Inc.
Responsible party
Sponsor
First posted
Sep 17, 2026
Start date
Feb 2027 (estimated)
Primary completion
Feb 2030 (estimated)
Completion
Feb 2030 (estimated)
Last update
Oct 13, 2026

Study contacts

Kirstin Liechty, PhD
Contact
kirstin.liechty@abelzeta.com
240-552-5870
Nurat Quadri, PhD
Contact
clinicaltrials@abelzeta.com
1 240 552 5870
Yihong Yao, PhD
study director · AbelZeta Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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