KYSA-7: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis

NCT06384976 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: KYSA-7KYV101-007
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis

Conditions

Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis; MS

Keywords

KYV-101; multiple sclerosis; autoimmune disease; anti-CD19 CAR-T therapy; cellular therapy; MS

Outcome Measures

Primary Outcomes (1)

• To evaluate efficacy of KYV-101

  Confirmed disability Progression on the EDSS scale. The EDSS scale ranges from 0 to 10 in 0.5- unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.

  at least 12 weeks

Secondary Outcomes (9)

• To characterize the safety and tolerability of KYV-101

  Up to 2 years

• To characterize the safety and tolerability of KYV-101

  Up to 2 years

• To characterize the safety and tolerability of KYV-101

  Up to 2 years

• To evaluate efficacy of KYV-101

  up to 12 weeks

• To characterize the pharmacokinetics (PK)

  Up to 2 years

Study Arms (2)

KYV-101 CAR-T cells with lymphodepletion conditioning

EXPERIMENTAL

Dosing with KYV-101 CAR T cells

Biological: KYV-101; Drug: Standard lymphodepletion regimen

Anti- CD20 mAb

ACTIVE COMPARATOR

Dosing with anti-CD20 mAb

Drug: Anti-CD20 mAB

Interventions

KYV-101 BIOLOGICAL

Anti-CD19 CAR-T cell therapy

KYV-101 CAR-T cells with lymphodepletion conditioning

Standard lymphodepletion regimen DRUG

CYC/FLU

KYV-101 CAR-T cells with lymphodepletion conditioning

Anti-CD20 mAB DRUG

Anti-CD20 mAB

Anti- CD20 mAb

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must have a history of diagnosis of primary progressive or secondary progressive MS.

You may not qualify if:

• Monophasic disease, radiologically isolated syndrome, clinically isolated syndrome, progressive solitary sclerosis or relapsing-remitting disease as defined by the 2017 McDonald criteria.
• History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-MS progressive neurologic condition or PML.
• Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target
• History of allogeneic or autologous stem cell transplant
• Evidence of active hepatitis B or hepatitis C infection
• Positive serology for HIV
• Primary immunodeficiency
• History of splenectomy
• History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject
• Impaired cardiac function or clinically significant cardiac disease
• Previous or concurrent malignancy with the following exceptions:
• Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening)
• In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening
• A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening

Sponsors & Collaborators

• Kyverna Therapeutics: lead

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• Silva BA, Miglietta E, Ferrari CC. Insights into the role of B cells in the cortical pathology of Multiple sclerosis: evidence from animal models and patients. Mult Scler Relat Disord. 2021 May;50:102845. doi: 10.1016/j.msard.2021.102845. Epub 2021 Feb 16.

  PMID: 33636613 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Kyverna Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: April 25, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)