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

NCT07825389 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ABZT-412
• Study Type: interventional
• Target: 119
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Multiple Sclerosis

Keywords

Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis;; SPMS; PPMS; CAR T-Cell Therapy; C-CAR168; CD20; BCMA

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Through Month 12

Secondary Outcomes (13)

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

  Through Month 12 (Phase 1b)

• Proportion of participants with 3m-cCDP

  Through Month 24

• Proportion of participants with 6m-cCDP

  Through Month 24

• Change from baseline in Expanded Disability Status Scale EDSS)

  Through Month 24

• Change from baseline in Functional Systems Score (FSS)

  Through Month 24

Study Arms (1)

C-CAR168

EXPERIMENTAL

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

Drug: C-CAR168

Interventions

C-CAR168 DRUG

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

C-CAR168

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbelZeta Inc.: lead

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kirstin Liechty

CONTACT

240-552-5870; kirstin.liechty@abelzeta.com

Nurat Quadri

CONTACT

1 240 552 5870; clinicaltrials@abelzeta.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 17, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share