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NCT06451159 · ClinicalTrials.gov registry record · Phase 1
A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis
A Phase 1 study of Progressive Multiple Sclerosis, sponsored by Bruce Cree.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06451159: Active Phase 1 study of Progressive Multiple Sclerosis, sponsored by Bruce Cree.
NCT06451159 is a Phase 1 study of Progressive Multiple Sclerosis that is active but no longer recruiting, run by Bruce Cree. The registered enrollment target is 10 participants, below the 23-participant average among 3 other Progressive Multiple Sclerosis trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06451159, a Phase 1 study of Progressive Multiple Sclerosis, is active but no longer recruiting, sponsored by Bruce Cree.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to test a drug called KYV-101 in people who have progressive multiple sclerosis (MS) and who have not responded to standard therapies to slow disease progression. The main questions it aims to answer are: * What is the highest therapy dose that can be given without causing harm? * Can this therapy enter the central nervous system? Participants will be asked to: * Attend 14 visits plus an 8-day inpatient hospital stay over the course of 58 weeks. * Complete apheresis and chemotherapy treatments in preparation for KVY-101 therapy. * Undergo medical and research testing such as physical and neurological exams, MRI, lumbar puncture, blood draws, questionnaires, and vision assessments.
Primary Outcome
To surmise CNS penetration of CAR-T cells.
Conditions Studied
Interventions
- BIOLOGICAL KYV-101 (Biological) - 0.33 ×10^8 cells
- BIOLOGICAL KYV-101 (Biological) - 1 ×10^8 cells
- DRUG Chemotherapy: cyclophosphamide (CYC)
- DRUG Chemotherapy: fludarabine (FLU)
Study Locations (1)
California
- University of California, San Francisco, Multiple Sclerosis Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-06-20 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What the registry record for NCT06451159 still lists
NCT06451159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 23-participant average among 3 other Progressive Multiple Sclerosis trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Progressive Multiple Sclerosis appearing as the primary indexed condition, and to 4 interventions - of which KYV-101 (Biological) - 0.33 ×10^8 cells is the first listed.
NCT06451159 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06451159 about?
NCT06451159 is a clinical study titled "A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis". The goal of this study is to test a drug called KYV-101 in people who have progressive multiple sclerosis (MS) and who have not responded to standard therapies to slow disease progression. The main questions it aims to answer are: * What is the highest therapy dose that can be given without causing...
What is the current status of trial NCT06451159?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2024-06-20. Estimated completion is 2027-02.
What conditions does trial NCT06451159 study?
This clinical trial studies the following conditions: Progressive Multiple Sclerosis.
What interventions are being tested in trial NCT06451159?
The interventions under investigation include: KYV-101 (Biological) - 0.33 ×10^8 cells (BIOLOGICAL), KYV-101 (Biological) - 1 ×10^8 cells (BIOLOGICAL), Chemotherapy: cyclophosphamide (CYC) (DRUG), Chemotherapy: fludarabine (FLU) (DRUG).
Who is sponsoring clinical trial NCT06451159?
This trial is sponsored by Bruce Cree, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06451159 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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