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

AbelZeta Inc.

Status and phase

Begins enrollment in 2 months

Phase 2

Phase 1

Conditions

Neuro-Degenerative Disease

Primary Progressive Multiple Sclerosis

Secondary Progress Multiple Sclerosis (SPMS)

Multiple Sclerosis

Autoimmune

Neuro-Degenerative Diseases

Primary Progressive Multiple Sclerosis (PPMS)

MS (Multiple Sclerosis)

Treatments

Drug: C-CAR168

Study type

Interventional

Funder types

Industry

Identifiers

NCT07825389

ABZT-412

Details and patient eligibility

About

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).

Enrollment

119 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.