A Clinical Study to Investigate the Safety and Efficacy of Off-the-Shelf iNKT Cell Injection Targ… (NCT07676006) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Clinical Study to Investigate the Safety and Efficacy of Off-the-Shelf iNKT Cell Injection Targeting CD33/CD70 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
China36 participantsStarted 2026-07-01
Plain-language summary
This is a single-arm, open-label, dose-escalation, prospective exploratory clinical study intended to evaluate the safety, efficacy and cellular pharmacokinetics of GT737 cells in adult patients with relapsed/refractory acute myeloid leukemia (AML).
Who can participate
Age range
18 Years – 75 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:
* 1\. Voluntarily participate in this clinical study, fully understand the study content, sign the informed consent form, and be willing to comply with all study procedures and complete all follow-up visits.
* 2\. Aged between 18 and 75 years old (inclusive), with no restriction on gender.
* 3\. Confirmed diagnosis of relapsed/refractory acute myeloid leukemia (AML) per the 2016 WHO Classification, with the specific definitions as follows:
Confirmed AML with bone marrow blasts ≥5% at screening, and meeting any one of the following criteria:
* Relapsed disease: Relapse after achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) following standard induction chemotherapy;
* Refractory disease: a) Failure to achieve CR/CRi after 2 cycles of induction chemotherapy; b) Relapse within 12 months of first remission with no response to subsequent re-treatment; c) Relapse after autologous or allogeneic hematopoietic stem cell transplantation; d) Failure to achieve CR/CRi after at least two lines of salvage therapy.
* 4\. Confirmed positive expression of CD33 or CD70 via flow cytometry and/or immunohistochemistry.
* 5\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* 6\. Estimated survival of more than 12 weeks.
* 7\. Toxicities resulting from prior therapies must be stabilized and recovered to Grade ≤1 (alopecia and other toxicities with no significant clinical impact are exclude…
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
1
Proportion of participants experiencing dose limiting toxicity
Timeframe: 28 days
2
Adverse Events (AEs) occurring after infusion and their proportions
Timeframe: 28 days
3
Severity of Adverse Events (AEs) after infusion
Timeframe: 28 days
4
Compare the differences in safety and tolerability between different treatment subgroups (monotherapy and combination with sirolimus).