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Trial Title:
Administration of Anti-siglec-6 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
NCT ID:
NCT05488132
Condition:
Acute Myeloid Leukemia Refractory
Acute Myeloid Leukemia, in Relapse
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
anti-siglec-6 CAR-T cell therapy
Description:
Enrolled patients will receive prespecified dose of autologous CAR-T cells.
Arm group label:
anti-siglec-6 CAR-T cell therapy
Summary:
To evaluate the safety and efficacy of anti-Siglec-6 CAR-T cells in the treatment of
relapsed and refractory acute myeloid leukemia.
Detailed description:
Sialic acid-binding immunoglobulin-like lectins (Siglec) are a class of classical
immunoglobulin-like lectins. Studies have shown that Siglec-6 is commonly expressed in
AML but not detected on normal hematopoietic stem and progenitor cells (HSC/P). In vitro
experiments revealed that anti-Siglec-6 CAR-T cell treatment did not affect the viability
or lineage differentiation in colony-forming assays. These data suggest that
anti-SigLlec-6 is an ideal target with great potential for treating acute myeloid
leukemia.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. All subjects must sign and date the Informed Consent before initiating any study
specific procedures or activities;
2. At the age of 18-70 years old;
3. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia
(AML);
4. The patient has recovered from the toxicity of previous treatment;
5. ECOG score ≤ 2 and expected survival period is not less than 3 months;
6. 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%;
7. Pregnancy testing: females of childbearing potential must have a negative serum or
urine pregnancy test;
8. 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:
1. Diagnosis of acute promyelocytic leukemia;
2. History or presence of a CNS disorder;
3. HBsAg is positive; HCV 、HIV or Syphilis antibody are positive, CMV DNA in peripheral
blood is more than≥500 copies /mL;
4. History of severe hypersensitivity reaction;
5. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,
New York Heart Association Class II or greater congestive heart failure, atrial
fibrillation, or other clinically significant cardiac disease within 12 months
before enrollment;
6. History of organ transplant surgery;
7. Required systemic application of immunosuppressive or other drugs;
8. Auto-SCT within the 3 months before enrollment;
9. Active autoimmune or inflammatory diseases of the nervous system (e.g.,
Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically
active cerebrovascular diseases (e.g., cerebral edema, posterior reversible
encephalopathy syndrome (PRES));
10. Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg,
leukostasis or tumor lysis syndrome (TLS)) ;
11. Presence or suspicion of a fungal, bacterial, viral, or other infection that is
uncontrolled or requiring antimicrobials for management;
12. Live vaccine received within the ≤ 4 weeks before enrollment;
13. Persons with serious mental illness;
14. History of major surgical operations four weeks before enrollment;
15. History of alcoholism or substance abuse;
16. Was identified by the investigators as unsuitable to participate in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Kailin Xu
Address:
City:
Xuzhou
Zip:
221000
Country:
China
Status:
Recruiting
Contact:
Last name:
Kailin Xu, M.D., Ph.D.
Phone:
86-516-85802007
Start date:
April 1, 2022
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Xuzhou Medical University
Agency class:
Other
Source:
Xuzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05488132
