A Study of HY004 Treatment in Adult Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)
NCT06009107 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2025-08-08
Summary
This is a multi-center, phase I/II trial to evaluate the safety and efficacy of HY004 treatment in Adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).
Conditions
Interventions
- BIOLOGICAL
-
HY004
A single infusion of Autologous 2nd generation CD19/CD22-directed CAR-T cells administered intravenously.
- DRUG
-
Administered intravenously.
- DRUG
-
Fludarabine Phosphate
Administered intravenously.
Sponsors & Collaborators
-
Juventas Cell Therapy Ltd.
lead INDUSTRY
Principal Investigators
-
Jianxiang Wang M.D. · Study Principal Investigator Institute of Hematology & Blood Diseases Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-30
- Primary Completion
- 2026-12-30
- Completion
- 2027-12-30
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