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

ConditionsMultiple SclerosisPrimary Progressive Multiple SclerosisSecondary Progress Multiple Sclerosis (SPMS)Primary Progressive Multiple Sclerosis (PPMS)MSMS (Multiple Sclerosis)Neuro-Degenerative DiseaseNeuro-Degenerative DiseasesAutoimmune
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAbelZeta Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • C-CAR168

    Drug

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

Treatment groups

119 Participants
are divided into 1 treatment group
Group A: C-CAR168Experimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AbelZeta Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: