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

X

Xuzhou Medical University

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Acute Myeloid Leukemia Refractory
Acute Myeloid Leukemia, in Relapse

Treatments

Drug: anti-siglec-6 CAR-T cell therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05488132
XYFY2022-KL119-01

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

anti-siglec-6 CAR-T cell therapy
Experimental group
Description:
anti-siglec-6 CAR-T cell therapy
Treatment:
Drug: anti-siglec-6 CAR-T cell therapy

Trial contacts and locations

1

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Central trial contact

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

Data sourced from clinicaltrials.gov

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