A Study of HY004 Treatment in Adult Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)
Reason given: Sponsor changed product development plan
Key facts
- Phase
- Phase 1/2
Trial details
- Who runs it
- Juventas Cell Therapy Ltd.
- Trial code
- NCT06009107
- Record updated
- 8 August 2025
- Original description
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).Read full original descriptionShow less
A Phase I/II, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of HY004 in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)
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).
Inclusion: Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian); Gender is not limited, and the age at the time of screening is ≥ 18 years old and ≤ 65 years old; Relapsed or refractory acute lymphoblastic leukemia (ALL); Documentation of CD19 and/orCD22 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening; Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening; ECOG score 0-1 points; Organ function requirements: All patients must have adequate renal and liver functions.
Exclusion: History of concomitant genetic syndrome; Patients with acute graft-versus-host disease (GVHD) or moderate-tosevere chronic GVHD within 4 weeks before screening; Patients with a history of allogeneic hematopoietic stem cell transplantation within 12 weeks before single collection; Patients who have used CAR-T cell therapy before screening; Active Central Nervous System (CNS) involvement by malignancy; Isolated extra-medullary disease relapse; Active systemic autoimmune disease; Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti- HCV positive); Patients with active infections at screening; Patients with Burkitt's lymphoma/leukemia; Patients with an expected lifespan of less than 3 months.