A Phase 1/2 interventional study of HY004 and Cyclophosphamide in B-cell Acute Lymphoblastic Leukemia, sponsored by Juventas Cell Therapy Ltd.. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Juventas Cell Therapy Ltd. · Phase 1/2, Interventional, and Treatment
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).
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.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
Browse Burkitt Lymphoma studies →Juventas Cell Therapy Ltd. is the lead sponsor of 15 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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).
Biological: HY004 · Drug: Cyclophosphamide · Drug: Fludarabine Phosphate
A single infusion of Autologous 2nd generation CD19/CD22-directed CAR-T cells administered intravenously.
Administered intravenously.
Administered intravenously.
Overall Remission Rate (ORR)
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).
Time frame: at the end of Month 3
Overall Remission Rate (ORR)
ORR is defined as Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) per NCCN classification.
Time frame: within 3 months
Best overall response (BOR)
The proportion of patients who have achieved the best response (CR or CRi) after HY004 treatment.
Time frame: up to 2 years
Overall Remission Rate (ORR) with minimal residual disease (MRD) negativity
Overall Remission Rate (ORR) with minimal residual disease (MRD) negativity as determined by IRC and Investigators; MRD negativity as determined using flow cytometry.
Time frame: at the end of Month 3
Duration of remission (DOR)
DOR is defined as the time between their first complete response per independent review to relapse or any death in the absence of documented relapse.
Time frame: to data cutoff date
Allogeneic Stem Cell Transplant (Allo-SCT) rate
The proportion of patients who have received Allo-SCT after HY004 treatment.
Time frame: First infusion date of HY004 to data cutoff date(up to 2 years)
Relapse Free Survival (RFS)
RFS is defined as the time from the HY004 infusion date to the date of disease relapse or death from any cause.
Time frame: up to 2 years
Event-Free Survival(EFS)
EFS is defined as the time from the HY004 infusion date to the date of any event, including disease progression, cessation of treatment for any reason, or death.
Time frame: up to 2 years
Overall survival (OS)
OS is defined as the time from the HY004 Cell Injection infusion to the date of death from any cause.
Time frame: 2 years
Percentage of Participants Experiencing Treatment-Emergent Adverse Events（TEAE）
Evaluate the type, frequency, severity of adverse events, and abnormal laboratory test values; Evaluate the frequency and severity of adverse events related to HY004.
Time frame: up to 2 years
In vivo cellular Pharmacokinetic (PK) profile of HY004 in units of transgene copy number per genomic DNA (gDNA) amount.
To characterize the in vivo cellular pharmacokinetic (PK) profile (levels, persistence, trafficking) of HY004 cells in target tissues (blood, bone marrow andCerebral Spinal Fluid (CSF)if available)by quantitative polymerase chain reaction(qPCR).
Time frame: Up to 3 months(BM sample); Up to 2 years(Blood sample)
In vivo cellular Pharmacokinetic (PK) profile of HY004 in units of percent of CAR-positive cells.
To characterize the in vivo cellular pharmacokinetic (PK) profile (levels, persistence, trafficking) of HY004 cells in target tissues (blood, bone marrow andCerebral Spinal Fluid (CSF)if available)by Flow Cytometry.
Time frame: Up to 3 months(BM sample); Up to 2 years(Blood sample)
In vivo cellular pharmacodynamics (PD) profile of HY004.
To characterize the concentration of cytokines ,including Interleukin-6(IL-6) at least in Serum.
Time frame: 28 days
Prevalence and incidence of humoral immunogenicity to HY004.
To characterize the concentration of anti-drug antibodies.
Time frame: 2 years
No study locations are listed for this record.
Plan to share: No — Currently the investigators have no plan of interim anaylsis, the investigators don't plan to share individual participant data(IPD) during the trial on-going.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Juventas Cell Therapy Ltd.