WithdrawnEarly Phase 1

γδ T Cell Therapy for Relapse Prevention in High-Risk AML Post-Transplant

Stopped: Due to corporate strategic adjustment.

0Started 2025-09-01

Plain-language summary

This is a prospective, double-arm, single-center, randomized controlled single-blind clinical study

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

. Patients voluntarily sign informed consent and are expected to complete the follow-up examination and treatment of the study procedures;
. Age 18-65 years old (including cut-off value), gender is not limited;
. AML patients have one of the high-risk factors for recurrence after allogeneic hematopoietic stem cell transplantation;
. AML patients need to meet 30±5 days after the end of allogeneic transplant therapy;
. The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \< 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);
. ECOG performance status score of 0-3 points and expected survival greater than 3 months ;
. Have appropriate organ function:
. Alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN);

Exclusion criteria

. Other malignant tumors within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary carcinoma of the thyroid, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;

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

Incidence of Treatment-Emergent Adverse Events

Timeframe: Up to 12 months.

Trial details

NCT IDNCT07123662

SponsorGuangzhou Bio-gene Technology Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-05-30

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