Not yet recruitingPhase 1Phase 2Progressive MSNCT07804004

What it found

Still running

No result yet.

What was tested

Treatment tested

  • CTX112

What it measured

Main measures

  • To evaluate the safety of CTX112 in adult participants with neurological autoimmue disorders, including PMS, relapsing NMOSD, relapsing MOGAD, refractory AIE, and refractory SPS.

    From CTX112 infusion up to 28 days post infusion

    Safety

Other measures (7)

  • To assess the pharmacodynamics response to CTX112 in adults with neurological autoimmune disorders

    From CTX112 infusion up to 24 months post-infusion

    Immune response
  • To assess the pharmacokinetics (PK) of CTX112 in adults with neurological autoimmune disorders.

    From CTX112 infusion up to 24 months post-infusion.

    How the body handles the medicine
  • To assess the preliminary efficacy of CTX112 in adults with PMS.

    From CTX112 infusion up to Month 6, Month 12, Month 18, and Month 24

    Disability progression
  • To assess the preliminary efficacy of CTX112 in adults with NMOSD.

    From CTX112 infusion up to Month 6, Month 12, Month 18, and Month 24

    Relapses
  • To assess the preliminary efficacy of CTX112 in adults with MOGAD

    From CTX112 infusion up to Month 6, Month 12, Month 18, and Month 24

    Relapses
  • To assess the preliminary efficacy of CTX112 in adults with AIE

    From CTX112 infusion up to Month 6, Month 12, Month 18, and Month 24

  • To assess the preliminary efficacy of CTX112 in adults with SPS

    From CTX112 infusion up to Month 6, Month 12, Month 18, and Month 24

Who could take part

Progressive MS · 18 to 70

Inclusion Criteria: 1. Age ≥18 years and \<70 years at screening. 2. Body weight >40 kg. 3. Participants must voluntarily sign a written informed consent and be willing and able to comply with all trial requirements. Legal authorized representative, additional assent and witness may be used as appropriate. 4. Adequate hematologic, renal, liver, cardiac and pulmonary function. 5. Participants must agree to use acceptable methods of contraception. 6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other trial procedures. 7. Confirmed diagnosis of PMS, relapsing NMOSD, relapsing MOGAD, refractory AIE, and refractory SPS Exclusion Criteria: 1. Prior treatment with any gene therapy or genetically modified cell therapy. 2. Prior solid organ (e.g., heart, liver, kidney, lung) transplant or hematopoietic cell transplant. 3. Presence of another clinically significant central nervous (CNS) pathology or another condition that in the opinion of the investigator may increase CART cell-related toxicities or confound disease assessments for the main indication. 4. Presence of other active autoimmune disease or other conditions that are likely to pose increased safety risks and/or confound disease assessments, or pose significant risk to those receiving CART cell therapy. 5. Presence or history of certain bacterial, viral or fungal infection. 6. Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence). 7. History or current diagnosis that requires uninterrupted, ongoing anticoagulation. 8. Pregnant or lactating. 9. Presence or history of disease requiring treatment that is not compatible with the study protocol; presence or history of other conditions that are not compatible with the study protocol. 10. History of suicide attempts within 3 years prior to screening. 11. Any contraindications to lumbar puncture or MRI scans

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

This is a single-arm, open-label, multicenter, ascending dose Phase 1/2 trial evaluating the safety and preliminary efficacy of CTX112 in adult participants with neurological autoimmune diseases (AIDs), including Progressive Multiple Sclerosis, relapsing Neuromyelitis Optica Spectrum Disorder, relapsing Myelin Oligodendrocyte Glycoprotein Antiody-Associated Disease, refractory AutoImmune Encephalitis, and refractory Stiff Person Syndrome

Papers

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    History

      1. Started

        Nov 2026

      2. Main results due

        Dec 2029

      3. Finished

        Dec 2029

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