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A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia

NCT06770504 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-01-13

No results posted yet for this study

Summary

This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The primary objective is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of YTS109 START T-cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy.

Conditions

  • Autoimmune Hemolytic Anemia
  • Anti-CD19 STAR T-cell Therapy
  • Failure ≥3 Lines of Therapies

Interventions

BIOLOGICAL

YTS109

In this study, subjects will receive YTS109 Cell Injection(0.5-1E6 STAR+T cell/kg) once.

Sponsors & Collaborators

  • China Immunotech (Beijing) Biotechnology Co., Ltd.

    collaborator INDUSTRY

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2025-12-30
Completion
2026-12-30

More Related Trials

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 NCT06770504 on ClinicalTrials.gov