AzTrials
AzTrials

B-cell Acute Lymphoblastic LeukemiaPhase 1/2B-ALLNCT06009107

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

A Phase 1/2 study testing HY004, Cyclophosphamide and Fludarabine Phosphate in people with B-cell Acute Lymphoblastic Leukemia, run by Juventas Cell Therapy Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
B-cell Acute Lymphoblastic Leukemia
What is being tested?
HY004, Cyclophosphamide and Fludarabine Phosphate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Jun 2025to 30 Dec 2027
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 10Show fewer
  • 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.

About this study

Official title: 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)

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).

Read the 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.

Keywords
HY004, Cluster of differentiation antigen 19 and/or 22(CD19 and/or 22), CD19/22-directed CAR-T cells
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HY004Biological

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

  • CyclophosphamideDrug

    Administered intravenously.

  • Fludarabine PhosphateDrug

    Administered intravenously.

Study groups in NCT06009107
Study groupRoleWhat they receive
Participant GroupExperimentalParticipants 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).
Receives: Biological: HY004; Drug: Cyclophosphamide; Drug: Fludarabine Phosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: at the end of Month 3

Secondary outcomes (9)

  1. Overall Remission Rate (ORR)

    ORR is defined as Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) per NCCN classification.

    Measured: within 3 months

  2. Best overall response (BOR)

    The proportion of patients who have achieved the best response (CR or CRi) after HY004 treatment.

    Measured: up to 2 years

  3. 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.

    Measured: at the end of Month 3

  4. 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.

    Measured: to data cutoff date

  5. Allogeneic Stem Cell Transplant (Allo-SCT) rate

    The proportion of patients who have received Allo-SCT after HY004 treatment.

    Measured: First infusion date of HY004 to data cutoff date(up to 2 years)

  6. 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.

    Measured: up to 2 years

  7. 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.

    Measured: up to 2 years

  8. Overall survival (OS)

    OS is defined as the time from the HY004 Cell Injection infusion to the date of death from any cause.

    Measured: 2 years

  9. 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.

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2023
  2. Study start30 Jun 2025 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Why it stopped: Sponsor changed product development plan

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06009107
Sponsor's protocol ID
HY004101
Acronym
B-ALL
Status last verified
Aug 2025
First submitted
18 Aug 2023
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HY004, Cyclophosphamide and Fludarabine Phosphate in people with B-cell Acute Lymphoblastic Leukemia, run by Juventas Cell Therapy Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Remission Rate (ORR) (time frame: at the end of Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06009107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in