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A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis

NCT06451159 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-23

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

KYV-101 (Biological) - 0.33 ×10^8 cells

KYV-101 is a type of treatment called CAR T-cell therapy. It uses cells from your own immune system, called T-cells, to attack cells that cause inflammation. T-cells are a type of white blood cell.

BIOLOGICAL

KYV-101 (Biological) - 1 ×10^8 cells

KYV-101 is a type of treatment called CAR T-cell therapy. It uses cells from your own immune system, called T-cells, to attack cells that cause inflammation. T-cells are a type of white blood cell.

DRUG

Chemotherapy: cyclophosphamide (CYC)

Participants will receive one 3-day cycle of lymphodepletion with CYC 300 mg/m2 prior to administration of KYV-101.

DRUG

Chemotherapy: fludarabine (FLU)

Participants will receive one 3-day cycle of lymphodepletion with FLU 30 mg/m2 prior to administration of KYV-101.

Sponsors & Collaborators

  • Kyverna Therapeutics

    collaborator INDUSTRY

  • Bruce Cree

    lead OTHER

Principal Investigators

  • Bruce Cree, MD, PhD, MAS · University of California, San Francisco

  • Sasha Gupta, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2026-02-28
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06451159 on ClinicalTrials.gov