Clinical trial · Interventional
A Study of HY004 Treatment in Adult Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)
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)
NCT06009107CI-TRIAL-00093367B-ALLwithdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor changed product development plan
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine Phosphate | Drug | Fludarabine | ALIAS |
| HY004 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participant Group
- description
- Participants with relapsed or refractory B-precursor acute lymphoblastic leukemia (r/r B-ALL) will receive conditioning chemotherapy (fludarabine 25-30 mg/m\^2 intravenously \[IV\] over 30 minutes on Day -5, Day -4, and Day -3 and cyclophosphamide 500 mg/m\^2 IV over 60 minutes on Day -5, Day -4), following a single IV infusion of chimeric antigen receptor (CAR) transduced autologous T cells(HY004).
- interventionNames
- Biological: HY004
- Drug: Cyclophosphamide
- Drug: Fludarabine Phosphate
Primary outcomes (1)
- measure
- Overall Remission Rate (ORR)
- timeFrame
- at the end of Month 3
- description
- ORR is defined as Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) per NCCN classification, as determined by Independent Review Committee (IRC).
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian); 2. Gender is not limited, and the age at the time of screening is ≥ 18 years old and ≤ 65 years old; 3. Relapsed or refractory acute lymphoblastic leukemia (ALL); 4. Documentation of CD19 and/orCD22 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening; 5. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening; 6. ECOG score 0-1 points; 7. Organ function requirements: All patients must have adequate renal and liver functions. Exclusion Criteria: 1. Active Central Nervous System (CNS) involvement by malignancy; 2. Isolated extra-medullary disease relapse; 3. Patients with Burkitt's lymphoma/leukemia; 4. History of concomitant genetic syndrome; 5. 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; 6. Active systemic autoimmune disease; 7. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti- HCV positive); 8. Patients with active infections at screening; 9. Patients who have used CAR-T cell therapy before screening; 10. Patients with an expected lifespan of less than 3 months.
References
Publications (0)
Data not yet available
No reference posted for this study.