UnknownPhase 1/2

Administration of Anti-siglec-6 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)

China20 participantsStarted 2022-04-01

Plain-language summary

To evaluate the safety and efficacy of anti-Siglec-6 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.

Who can participate

Age range

18 Years – 70 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

. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
. At the age of 18-70 years old;
. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
. The patient has recovered from the toxicity of previous treatment;
. ECOG score ≤ 2 and expected survival period is not less than 3 months;
. Adequate organ function defined as:AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%;
. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;
. From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception.

Exclusion criteria

. Diagnosis of acute promyelocytic leukemia;
. History or presence of a CNS disorder;

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

Dose-limiting toxicity（DLT）

Timeframe: Baseline up to 28 days after T cell infusion

Trial details

NCT IDNCT05488132

SponsorXuzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-31

Contact for this trial

Kailin Xu, M.D., Ph.D.

15162166166 lihmd@163.com

View on ClinicalTrials.gov More Acute Myeloid Leukemia Refractory trials