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Trial Title:
A Study of HY004 Treatment in Adult Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)
NCT ID:
NCT06009107
Condition:
B-cell Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Conditions: Keywords:
HY004
Cluster of differentiation antigen 19 and/or 22(CD19 and/or 22)
CD19/22-directed CAR-T cells
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
HY004
Description:
A single infusion of Autologous 2nd generation CD19/CD22-directed CAR-T cells
administered intravenously.
Arm group label:
Participant Group
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Administered intravenously.
Arm group label:
Participant Group
Intervention type:
Drug
Intervention name:
Fludarabine Phosphate
Description:
Administered intravenously.
Arm group label:
Participant Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
August 31, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Juventas Cell Therapy Ltd.
Agency class:
Industry
Source:
Juventas Cell Therapy Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06009107
