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

NCT ID: NCT04008381

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2023-01-01

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.

Detailed Description

This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T-lymphocytes in patients with relapsed or refractory acute myeloid leukemia. PBMCs will be separated from peripheral blood of suitable donors. After making them potential cancer killer γδ T Cells, they will be infused to the patients as an immunotherapy treatment.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ex-vivo Expanded γδ T Lymphocytes

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).

Group Type: EXPERIMENTAL

Ex-vivo Expanded γδ T Lymphocytes

Intervention Type: 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).

Interventions

Ex-vivo Expanded γδ T Lymphocytes

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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 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)

2. 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.

3. Presence of > 5% of blasts in bone marrow or peripheral blood smear

4. Patient not eligible for or does not consent to high dose salvage chemotherapy and/or allogeneic Haematopoietic Cell Transplantation (HCT)

5. Considered suitable for lymphodepleting chemotherapy

6. The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.

7. 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%;

8. Life expectancy of at least 3 months

9. Patient ECOG score≤2, Estimated survival time≥3 months.

10. 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.

11. 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).

12. Patient able to understand and sign written informed consent

13. Age 18 years up to the age of 75 (≤ 75)

Exclusion Criteria

1. Women who are pregnant (urine/blood pregnancy test positive) or lactating.

2. Male or female with a conception plan in the past 1 years.

3. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment.

4. Uncontrolled infectious disease within 4 weeks prior to enrollment.

5. Active hepatitis B/C virus.

6. HIV infected patients.

7. Suffering from a serious autoimmune disease or immunodeficiency disease.

8. The patient is allergic and is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.

9. The patient participated in other clinical trials within 6 weeks prior to enrollment.

10. Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).

11. Have a history of epilepsy or other central nervous system diseases.

12. Having drug abuse/addiction.

13. According to the researcher's judgment, the patient has other unsuitable grouping conditions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinan University, China

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

MEI HENG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heng Mei, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Hu, M.D. Ph.D

Role: CONTACT

dr_huyu@126.com

86-13986183871

Heng Mei, M.D. Ph.D

Role: CONTACT

hmei@hust.edu.cn

86-13886160811

Facility Contacts

Yu Hu, M.D., Ph.D

Role: primary

dr_huyu@126.com

86-13986183871

Heng Mei, M.D., Ph.D

Role: backup

hmei@hust.edu.cn

86-13886160811

Other Identifiers

WHUH-2009-V010

Identifier Type: -

Identifier Source: org_study_id