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New treatment option for Refractory Acute Myeloid Leukemia
Official title Clinical Study of LILRA6 CAR-T for the Treatment of R/R Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT07263906
What this study is testing
What is Anti-LILRA6 CAR-T cells?
Anti-LILRA6 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for refractory acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the safety and efficacy of LILRA6-directed chimeric antigen receptor T cells (LILRA6 CAR-T cells) in patients with refractory or relapsed acute myeloid leukemia(AML).
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily participate in this study and sign the informed consent form.
- Age range: 18 - 75 years old. Gender is not restricted.
- Refractory/Recurrent AML: Meeting any one of the following criteria for refractory or recurrent cases is sufficient. 1) Refractory: (1) In the case...
- Expected survival period ≥ 12 weeks.
- The positive rate of LILRA6 expression in bone marrow/tumor cells is ≥ 20%
You likely can't join if
- Those who have a severe history of allergic reaction to any component of the cell preparation or the pre-treatment chemotherapy drugs.
- Those with a history of other active malignant tumors.
- There are active infections that require treatment (excluding simple urinary tract infections and bacterial pharyngitis); the use of prophylactic...
- Active hepatitis B (with HBsAg positive and HBV-DNA ≥ 10³ copies/mL), hepatitis C infection, syphilis, or other acquired/innate immune deficiency...
- According to the New York Heart Association (NYHA) classification of cardiac function, those with cardiac function at grade III or IV.
- Previous anti-tumor treatment-related toxic reactions have not yet recovered to a grade ≤ 1 (according to CTCAE 5.0), except for fatigue, anorexia...
See the full eligibility criteria
- Voluntarily participate in this study and sign the informed consent form.
- Age range: 18 - 75 years old. Gender is not restricted.
- Refractory/Recurrent AML: Meeting any one of the following criteria for refractory or recurrent cases is sufficient. 1) Refractory: (1) In the case of a newly diagnosed patient, treatment with the standard regimen for...
- Expected survival period ≥ 12 weeks.
- The positive rate of LILRA6 expression in bone marrow/tumor cells is ≥ 20%
- ECOG score ranging from 0 to 2 points.
- Sufficient organ function reserve: Alanine aminotransferase and Aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value); Creatinine clearance rate (Cockcroft-Gault method) ≥ 45 mL/min; Serum total bilirubin...
- Allow those who have previously undergone a single autologous hematopoietic stem cell transplantationAllowing previous recipients of a single autologous hematopoietic stem cell transplantation.
- Pregnancy tests for the female people of childbearing age must be negative, and they must also agree to take effective contraceptive measures during the trial.
- There are no uncontrollable infectious activities (including lung infections).
- Distance from the last anti-tumor treatment: Systemic chemotherapy / systemic radiotherapy / immunotherapy ≥ 3 weeks, targeted drug elution period ≥ 2 weeks.
- No active infection of the novel coronavirus or influenza.
- Those who have a severe history of allergic reaction to any component of the cell preparation or the pre-treatment chemotherapy drugs.
- Those with a history of other active malignant tumors.
- There are active infections that require treatment (excluding simple urinary tract infections and bacterial pharyngitis); the use of prophylactic antibiotics, antiviral drugs, and antifungal drugs is permitted.
- Active hepatitis B (with HBsAg positive and HBV-DNA ≥ 10³ copies/mL), hepatitis C infection, syphilis, or other acquired/innate immune deficiency disorders (including HIV infection).
- According to the New York Heart Association (NYHA) classification of cardiac function, those with cardiac function at grade III or IV.
- Previous anti-tumor treatment-related toxic reactions have not yet recovered to a grade ≤ 1 (according to CTCAE 5.0), except for fatigue, anorexia and hair loss.
- Those with a history of epilepsy or other central nervous system diseases that may affect the research assessment. 8: Those who have received any other targeted LILRA6 drug treatment before. 9.Breastfeeding women who do...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.