Clinical Study of Anti-ILT3 CAR-T Therapy for R/R AML(M4/M5)

NCT04803929 | Recruiting Early Phase 1 DMC

• 1 other identifier: 2021KY014
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

AML M4; AML M5

Outcome Measures

Primary Outcomes (2)

• Rate of grade 3 or 4 treatment related adverse effects

  All the CAR-T treatment related adverse events，including Dose limiting toxicity (DLT), cytokine release syndrome (CRS), CAR-T associated encephalopathy syndrome, will be assessed and graded by NCI CTCAE v 5.0.

  up to 24 weeks after first infusion

• Implantation endpoint

  To assess the duration of CAR-positive T cells in circulation, the copy number of CAR DNA was measured at the preset follow-up time point. The time when the results of any two consecutive tests were negative, were recorded as the "implantation endpoint"

  up to 2 years after first infusion

Secondary Outcomes (5)

• Disease specific response

  up to 2 years after first infusion

• Overall survival

  up to 2 years after inclusion

• Progress-free survival

  up to 2 years after inclusion

• CAR-T residue

  up to 2 years after first infusion

• Minimal residual disease (MRD)

  up to 2 years after first infusion

Study Arms (1)

Anti-ILT3 CAR-T cells

EXPERIMENTAL

All subjects were intravenous administrated with anti-ILT3 CAR-T cells

Biological: anti-ILT3 CAR-T

Interventions

anti-ILT3 CAR-T BIOLOGICAL

Autologous T cells genetically modified with anti-ILT3 CAR

Anti-ILT3 CAR-T cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, aged ≥18 years or ≤70 years;
• 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%)
• 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.
• 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%.
• ECOG physical status score 0-3.
• No use of steroid hormones within 2 weeks.
• Sufficient venous access to single or venous blood collection is available, and there are no other contraindications to blood cell separation.
• Signed written informed consent form.

You may not qualify if:

• Subjects will not be included in the study if they meet any of the following criteria:
• Pregnant or lactating women;
• HIV serological positive;
• Active bacterial, fungal or viral infections that are not controlled by treatment;
• Suffer from coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage or other serious cardiovascular and cerebrovascular diseases;
• 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;

Sponsors & Collaborators

• Carbiogene Therapeutics Co. Ltd.: lead
• Zhejiang Provincial People's Hospital: collaborator

Study Sites (1)

Zhejiang Provincal People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute

Study Officials

• Jianping Lan

  Zhejiang Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lai Jin

CONTACT

+86-18458227035; hjdl188@sina.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 18, 2021
• Study Start: March 3, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2026
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

CN (1)