Ex-vivo Expanded γδ T Lymphocytes in Patients With Refractory/Relapsed Acute Myeloid Leukaemia

NCT04008381 | Unknown Phase 1

• 1 other identifier: WHUH-2009-V010
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the potential curative properties of ex-vivo expanded gamma delta T-cells obtained from a blood-related donor for patients with relapsed or refractory acute myeloid leukemia.

Conditions

Acute Myeloid Leukemia

Keywords

gamma-delta T; Refractory/Relapsed

Outcome Measures

Primary Outcomes (2)

• Four-months remission rate

  Number of patients reaching Complete Remission (CR) according to National Comprehensive Cancer Network (NCCN, Version 1.2015).

  4 months

• Number of participants with adverse events (AEs)

  Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).

  3 years

Secondary Outcomes (5)

• Overall survival

  3 years

• Event-free survival

  3 years

• Relapse-free survival

  3 years

• Quantity of gamma-delta T cells in bone marrow cells and peripheral blood cells

  3 years

• lymphocyte subsets function assessment of bone marrow cells and peripheral blood cells

  3 years

Study Arms (1)

Ex-vivo Expanded γδ T Lymphocytes

EXPERIMENTAL

Patients receive ex-vivo expanded γδ T Lymphocytes (Dose escalation, 2\*10\^6, 4\*10\^6, 8\*10\^6 of cells per kg of body weight).

Biological: Ex-vivo Expanded γδ T Lymphocytes

Interventions

Ex-vivo Expanded γδ T Lymphocytes BIOLOGICAL

Patients receive ex-vivo expanded γδ T Lymphocytes (Dose escalation, 2\*10\^6, 4\*10\^6, 8\*10\^6 of cells per kg of body weight).

Ex-vivo Expanded γδ T Lymphocytes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of acute myeloid leukaemia (initially diagnosed by presence of 20% or more blast cells with myeloid or monocytic differentiation confirmed by flow cytometry in peripheral blood or bone marrow)
• Relapsed or refractory AML. A. AML relapse after intensive chemotherapy; B. AML relapse after allogeneic HCT; C. AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine); D. No response to at least 4 cycles of low intensity therapy; E. AML refractory to 2 cycles of induction chemotherapy.
• Presence of \> 5% of blasts in bone marrow or peripheral blood smear
• Patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT)
• Considered suitable for lymphodepleting chemotherapy
• The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.
• Patient's main organs function well. A. Liver function: ALT/AST \< 3 times the upper limit of normal (ULN); B. total bilirubin≤34.2μmol/L; C. Renal function: Creatinine \< 220μmol/L; D. Pulmonary function: Indoor oxygen saturation≥95%; E. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%;
• Life expectancy of at least 3 months
• Patient ECOG score≤2, Estimated survival time≥3 months.
• Ability to be off systemic prednisone and other immunosuppressive drugs for at least 3 days prior to γδ T cells product infusion. Maintenance replacement steroid is allowed.
• The patients did not receive any anticancer treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before admission, and the toxicity related to previous treatments had returned to \< 1 level at admission (except for low toxicity such as alopecia).
• Patient able to understand and sign written informed consent
• Age 18 years up to the age of 75 (≤ 75)

You may not qualify if:

• Women who are pregnant (urine/blood pregnancy test positive) or lactating.
• Male or female with a conception plan in the past 1 years.
• Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.
• Uncontrolled infectious disease within 4 weeks prior to enrollment.
• Active hepatitis B/C virus.
• HIV infected patients.
• Suffering from a serious autoimmune disease or immunodeficiency disease.
• The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
• The patient participated in other clinical trials within 6 weeks prior to enrollment.
• Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
• Have a history of epilepsy or other central nervous system diseases.
• Having drug abuse/addiction.
• According to the researcher's judgment, the patient has other unsuitable grouping conditions.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Jinan University, China: collaborator

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Heng Mei, M.D. Ph.D

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Hu, M.D. Ph.D

CONTACT

86-13986183871; dr_huyu@126.com

Heng Mei, M.D. Ph.D

CONTACT

86-13886160811; hmei@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: September 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: January 1, 2023
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)