WithdrawnPhase 1/2

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

Stopped: Sponsor changed product development plan

0Started 2025-06-30

Plain-language 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).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Active Central Nervous System (CNS) involvement by malignancy;
. Isolated extra-medullary disease relapse;
. Patients with Burkitt's lymphoma/leukemia;
. History of concomitant genetic syndrome;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Remission Rate (ORR)

Timeframe: at the end of Month 3

Trial details

NCT IDNCT06009107

SponsorJuventas Cell Therapy Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More B-cell Acute Lymphoblastic Leukemia trials