Brief Title
Clinical Study of Anti-ILT3 CAR-T Therapy for R/R AML(M4/M5)
Official Title
Clinical Study of Autologous T Cells Modified With ILT3 Chimeric Antigen Receptor for Relapsed/Refractory Acute Myeloid Leukemia (M4/M5)
Brief Summary
This study evaluates the safety and efficacy of novel ILT3-targeted CAR-T cell therapy for
patients with relapsed or refractory acute myeloid leukemia (M4/M5).
Detailed Description
Our group has developed a novel anti-ILT3 CAR T cell therapy, and this pilot study is focused
on the safety and efficacy of the anti-ILT3 CAR-T for R/R AML(M4/M5) patients. A total of 25
subjects are intravenously adminstered with anti-ILT3 CAR-T cells. The dosages of CAR-T cells
follow the "3+3" dose increment program.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Rate of grade 3 or 4 treatment related adverse effects
Secondary Outcome
Disease specific response
Condition
AML M4
Intervention
anti-ILT3 CAR-T
Study Arms / Comparison Groups
Anti-ILT3 CAR-T cells
Description: All subjects were intravenous administrated with anti-ILT3 CAR-T cells
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
25
Start Date
March 3, 2021
Completion Date
March 1, 2026
Primary Completion Date
March 1, 2024
Eligibility Criteria
Inclusion Criteria:
1. Male or female patients, aged ≥18 years or ≤70 years;
2. Acute myeloid leukemia AML M4/M5 subtype was diagnosed according to Fab standard
classification, confirmed by bone marrow IHC or ILT3-positive expression by flow
cytometry in monocytes (primary and young monocytes in bone marrow ≥20%)
3. Relapsed/refractory patients, whose conditions meet:
- Recurrent AML diagnosis standard: complete remission (CR) after the original
cells in peripheral blood again leukemia cells or bone marrow > 0.050 (with the
exception of consolidation chemotherapy after bone marrow regeneration for other
reasons) or myeloid leukemia cells infiltrating outside.
- Refractory AML diagnostic criteria: after two standard regimen for treatment
invalid early cure; patients who relapsed within 12 months after consolidation
and intensive treatment after CR; relapsed after 12 months but failed to respond
to conventional chemotherapy; 2 or more recurrences; patients with persistent
extramedullary leukemia.
4. Main organ functions meet the following conditions:
- Kidney function: creatinine clearance (absolute value) or 60 ml/min or creatinine
< 2.0 mg/dl or < 2 times the subjects' age group upper limit of normal (ULN)
blood.
- Liver function: ALT ≤ 3 or less ULN, AST ≤ 3 or less ULN.
- Heart function: the ejection fraction ≥ 50%, measured by echocardiography (ECHO)
or more acquisition scan (MUGA).
- Lung function: no clinical significance of pleural effusion, baseline blood
oxygen saturation > 92%.
5. ECOG physical status score 0-3.
6. No use of steroid hormones within 2 weeks.
7. Sufficient venous access to single or venous blood collection is available, and there
are no other contraindications to blood cell separation.
8. Signed written informed consent form.
Exclusion Criteria:
Subjects will not be included in the study if they meet any of the following criteria:
1. Pregnant or lactating women;
2. HIV serological positive;
3. Active bacterial, fungal or viral infections that are not controlled by treatment;
4. Suffer from coronary heart disease, angina pectoris, myocardial infarction,
arrhythmia, cerebral thrombosis, cerebral hemorrhage or other serious cardiovascular
and cerebrovascular diseases;
5. History and concomitant diseases:
- Subjects with known or suspected autoimmune diseases or immunodeficiency
diseases;
- Subjects requiring systemic treatment with corticosteroids or other
immunosuppressive agents during treatment;
- Subjects who have previously received other gene therapies;
- Subjects with a history of organ transplantation (referring to solid organ
transplantation);
- Subjects with severe mental disorders;
- Participated in other clinical studies within one month before the collection of
PBMC;
- Uncontrolled active hepatitis B and/or C infection (hepatitis B: HBV DNA > 500
IU/ml or copy number > 2500 copies /ml;
- Hepatitis C: HCV antibody positive and HCV-RNA levels above the detection limit);
- Any serious or uncontrolled disease that the Investigator considers to be likely
to increase the risk associated with study participation, study drug
administration, or affect the subject's ability to receive the study drug;
- Subjects who underwent major surgery or suffered significant trauma within 4
weeks prior to the collection of PBMCs, or who are expected to require major
surgery during the study period.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Jianping Lan, +86-18458227035, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04803929
Organization ID
2021KY014
Responsible Party
Sponsor
Study Sponsor
Carbiogene Therapeutics Co. Ltd.
Collaborators
Zhejiang Provincial People's Hospital
Study Sponsor
Jianping Lan, Principal Investigator, Zhejiang Provincial People's Hospital
Verification Date
March 2021