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FT819 in Moderate to Severe Active Systemic Lupus Erythematosus - Trial NCT06308978

Access comprehensive clinical trial information for NCT06308978 through Pure Global AI's free database. This Phase 1 trial is sponsored by Fate Therapeutics and is currently Recruiting. The study focuses on Systemic Lupus Erythematosus. Target enrollment is 32 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06308978
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06308978
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FT819 in Moderate to Severe Active Systemic Lupus Erythematosus
A Phase 1 Study of FT819 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Study Focus

FT819

Interventional

drug

Sponsor & Location

Fate Therapeutics

Minneapolis,Omaha, United States of America

Timeline & Enrollment

Phase 1

Feb 24, 2024

Sep 30, 2042

32 participants

Primary Outcome

Number of participants with treatment-emergent adverse events (TEAEs),Number of participants with serious TEAEs,Number of participants with adverse events of special interest (AESI),Number of participants with TEAEs by severity,Number of participants with dose-limiting toxicities (DLTs),Recommend Phase 2 dose (RP2D) of FT819

Summary

This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and
 anti-B-cell activity of FT819 following conditioning chemotherapy in participants with
 moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a
 dose-escalation stage, followed by an expansion stage to further evaluate the safety and
 activity of FT819.

ICD-10 Classifications

Systemic lupus erythematosus
Systemic lupus erythematosus, unspecified
Lupus erythematosus
Systemic lupus erythematosus with organ or system involvement
Other forms of systemic lupus erythematosus

Data Source

ClinicalTrials.gov

NCT06308978

Non-Device Trial