Active — Not RecruitingPhase 1/2

KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis

United States3 participantsStarted 2024-08-06

Plain-language summary

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Clinical diagnosis of SSc according to 2013 ACR/EULAR classification
✓. Clinical disease as follows: Classified as diffuse cutaneous SSc; ≤ 6 years since first non-Raynaud's sign or symptom; active disease
✓. Up to date on all recommended vaccinations per CDC or institutional guidelines for immune-compromised individuals

✕. Clinically significant ILD
✕. 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

Incidence of adverse events and laboratory abnormalities (Phase 1)

Timeframe: Up to 2 years

Frequency of Dose-Limiting Toxicities (DLTs) at each dose level (Phase 1)

Timeframe: Up to 2 years

To evaluate efficacy of KYV-101(Phase 2)

Timeframe: 52 weeks

NCT IDNCT06400303

SponsorKyverna Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03