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CAR T-cell Therapy

CAR T Cell Therapy for Multiple Sclerosis

Phase 1

Recruiting

Led By Bruce Cree, MD, PhD, MAS

Research Sponsored by Bruce Cree

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be 25-70 years of age

Clinical diagnosis of MS with evidence of primary or secondary progressive MS based on 2017 International Panel Criteria (Thompson 2018)

Must not have

History of splenectomy

Serious and/or uncontrolled medical condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening to week 48

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new drug, KYV-101, in people with progressive multiple sclerosis who have not responded to standard treatments. The study will determine the highest safe dose of the drug and

Who is the study for?

This trial is for people with progressive multiple sclerosis who haven't improved with standard treatments. They must be able to attend numerous visits, including an 8-day hospital stay, and undergo procedures like apheresis (a blood filtering process), chemotherapy, MRI scans, lumbar punctures, and vision tests over approximately 58 weeks.

What is being tested?

The study is testing KYV-101, a type of CAR T cell therapy designed for MS. It includes preparatory chemotherapy with cyclophosphamide and fludarabine before administering KYV-101. The aim is to find the highest safe dose of KYV-101 and see if it can reach the central nervous system.

What are the potential side effects?

Potential side effects may include those related to chemotherapy such as nausea, hair loss, mouth sores; immune reactions from CAR T cells like fever or fatigue; risks from apheresis; discomfort from spinal taps; plus any unforeseen effects specific to KYV-101.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 25 and 70 years old.

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I have been diagnosed with progressive MS.

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My disability level is moderate to severe but I can still walk.

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My condition has worsened in the last 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had my spleen removed.

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I do not have any serious or uncontrolled health conditions.

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I am not willing to do long-term follow-ups after CAR T therapy.

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I cannot stop my autoimmune disease treatment before undergoing apheresis.

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I have had progressive multifocal leukoencephalopathy in the past.

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I have not been treated for active or latent tuberculosis.

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I have heart problems or diseases.

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My MS has been stable on my current treatment.

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My first demyelinating event is not due to multiple sclerosis.

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I cannot or should not have an MRI.

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I have had a stem cell or organ transplant.

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I need to take blood thinners regularly.

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I have previously received CAR-T or gene therapy.

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I have a genetic disorder that affects my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The incidence and severity of adverse events and dose-limiting toxicities.

The presence of CAR-T cells in CSF following their peak expansion in peripheral blood.

Secondary study objectives

The proportion of participants in whom reduction of CSF OCB and/or normalization of CSF IgG Index are detected.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dosing Cohort #2: KYV-101 CAR+ T -- 1×10^8 cellsExperimental Treatment3 Interventions

An additional five participants are planned for enrollment at the higher dose level (1×10\^8 cells).

Group II: Dosing Cohort #1: KYV-101 CAR+ T -- 0.33 ×10^8 cellsExperimental Treatment3 Interventions

Five participants will be enrolled at the lower dose (0.33 ×10\^8 cells). Once safety and tolerability are adequately assessed, treatment will proceed to the higher dose level.

0 / 18Eligibility criteria met