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

11. september 2026 opdateret af: AbelZeta Inc.

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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

119

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: C-CAR168

Participants will receive:

Leukapheresis Fludarabine Cyclophosphamide Single intravenous infusion of C-CAR168
Medicin: C-CAR168
Autologous anti-CD20/BCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion following lymphodepleting chemotherapy.
Andre navne:
  • Autologous anti-CD20/BCMA CAR T-cell therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence and Severity of Treatment-Emergent Adverse Events
Tidsramme: Through Month 24
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
Tidsramme: Through Month 12
Proportion of participants within each Phase 2 cohort experiencing 6-month composite confirmed disability progression through Month 12
Through Month 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with 6m-cCDP - Through Month 12 (Phase 1b)
Tidsramme: Through Month 12 (Phase 1b)
Through Month 12 (Phase 1b)
Proportion of participants with 3m-cCDP
Tidsramme: Through Month 24
Through Month 24
Proportion of participants with 6m-cCDP
Tidsramme: Through Month 24
Through Month 24
Change from baseline in Expanded Disability Status Scale EDSS)
Tidsramme: Through Month 24
Through Month 24
Change from baseline in Functional Systems Score (FSS)
Tidsramme: Through Month 24
Through Month 24
Change from baseline in Timed 25-Foot Walk (T25FW)
Tidsramme: Through Month 24
Through Month 24
Change from baseline in 9-Hole Peg Test (9-HPT)
Tidsramme: Month 12 and Month 24
Month 12 and Month 24
Time to first 3m-cCDP
Tidsramme: Through Month 24
Through Month 24
Time to first 6m-cCDP
Tidsramme: Through Month 24
Through Month 24
MRI lesion changes
Tidsramme: Through Month 24
Through Month 24
Incidence and severity of adverse events and serious adverse events
Tidsramme: Through Month 24
Through Month 24
Pharmacokinetics of C-CAR168 measured by quantitative polymerase chain reaction (qPCR)
Tidsramme: Through Month 24
Characterize CAR T-cell expansion and persistence using qPCR
Through Month 24
Pharmacokinetics of C-CAR168 utilizing flow cytometry
Tidsramme: Through Month 24
Characterize T-cell expansion and persistence utilizing flow cytometry
Through Month 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AbelZeta Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. februar 2027

Primær færdiggørelse (Anslået)

1. februar 2030

Studieafslutning (Anslået)

1. februar 2030

Datoer for studieregistrering

Først indsendt

8. september 2026

Først indsendt, der opfyldte QC-kriterier

11. september 2026

Først opslået (Faktiske)

17. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ABZT-412

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data collected during this study will not be made available to other researchers.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner