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HY001N for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy.

NCT07748533 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-08-05

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if HY001N cell injection safety and tolerability in adult patients with autoimmune hemolytic anemia after failure of 3 or more lines of therapy. It will also learn about the efficacy of HY001N cell injection to treat adult patients with autoimmune hemolytic anemia. The main questions it aims to answer are:

Proportion of participants attaining a CR (defined as normalization of hemoglobin not attributed to transfusion effect and the normalization of hemolytic markers) or CRi (defined as normalization of hemoglobin not attributed to transfusion effect without normalization of hemolytic markers) after HY001N infusion? Proportion of participants attaining a PR (defined as hemoglobin ≥ 100 g/L or at least ≥ 20 g/L increase from baseline not attributed to transfusion effect) after HY001N infusion.

• What medical problems do participants have when taking HY001N cell injection?

Researchers will see if HY001N cell injection works to treat autoimmune hemolytic anemia.

Participants will:

* Take apheresis, lymphodepletion regimen and HY001N cell injection.
* Visit the clinic on schedule.

Conditions

  • Autoimmune Hemolytic Anemia (AIHA)

Interventions

DRUG

HY001N Cell Injection

Drug: HY001N Cell Injection The dose was incremented according to the "3+3" principle, and the three dose levels A, B and C were given in sequence at one time, which were respectively: A-1 dose group: 0.25×10\^5 CAR-T live cells /kg body weight Group A (initial dose) : 0.5×10\^5 CAR-T live cells /kg body weight Group B: 1.0×10\^5 CAR-T live cells /kg body weight Group C: 1.5×10\^5 CAR-T live cells /kg body weight

Sponsors & Collaborators

  • Juventas Cell Therapy Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-02
Primary Completion
2028-09-01
Completion
2028-10-01

Countries

  • China

Study Locations

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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 NCT07748533 on ClinicalTrials.gov