Status:
WITHDRAWN
A Study of HY004 Treatment in Adult Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)
Lead Sponsor:
Juventas Cell Therapy Ltd.
Conditions:
B-cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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).
Detailed Description
This trial is a multi-center, open label, single-arm, phase I/II trial to evaluate the safety and efficacy of HY004 treatment in Adult (aged 18\~65 years old) patients with r/r B-cell ALL. The phase ...
Eligibility Criteria
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
- Active Central Nervous System (CNS) involvement by malignancy;
- Isolated extra-medullary disease relapse;
- Patients with Burkitt's lymphoma/leukemia;
- 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;
- 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 who have used CAR-T cell therapy before screening;
- Patients with an expected lifespan of less than 3 months.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06009107
Start Date
June 30 2025
End Date
December 30 2027
Last Update
August 8 2025
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