A Study of HY004 Treatment in Adult Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)

NCT ID: NCT06009107

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-12-30

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 I part of the trial is to evaluate the safety, optimal dose of HY004, Pharmacokinetics/Pharmacodynamics(PK/PD)and preliminary efficacy in the treatment of Adult patients with r/r B-cell ALL. The phase II part of the trial is to evaluate the efficacy and safety of HY004 in in the treatment of Adult patients with r/r B-cell ALL. The study includes screening, pre-treatment (Cell Product manufacture & lymphodepletion), HY004 infusion, safety and efficacy follow-up, and survival follow-up. All subjects who have received HY004 infusion will be followed for up to 2 years.

Conditions

B-cell Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participant Group

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).

Group Type: EXPERIMENTAL

HY004

Intervention Type: BIOLOGICAL

A single infusion of Autologous 2nd generation CD19/CD22-directed CAR-T cells administered intravenously.

Cyclophosphamide

Intervention Type: DRUG

Administered intravenously.

Fludarabine Phosphate

Intervention Type: DRUG

Administered intravenously.

Interventions

HY004

A single infusion of Autologous 2nd generation CD19/CD22-directed CAR-T cells administered intravenously.

Intervention Type: BIOLOGICAL

Cyclophosphamide

Administered intravenously.

Intervention Type: DRUG

Fludarabine Phosphate

Administered intravenously.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juventas Cell Therapy Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianxiang Wang M.D.

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Institute of Hematology & Blood Diseases Hospital

Other Identifiers

HY004101

Identifier Type: -

Identifier Source: org_study_id