Ex-vivo Expanded γδ T-lymphocytes (OmnImmune®) in Patients With Acute Myeloid Leukaemia (AML)

NCT ID: NCT03790072

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2021-03-26

Brief Summary

This study investigates the potential curative properties of gamma delta T-cells obtained from a blood-related donor of an AML patient.

Detailed Description

This is an open-label, safety and efficacy, escalating dose, single arm study on 9 adult subjects (3 cohorts) and 3+3 design will be used. HLA typed patients and potential blood-related donors will be screened for comorbidities. Suitably matched or haploidentical family donors will be selected according to protocol specified criteria and institutional guidelines of participating site.

Conditions

Acute Myeloid Leukemia

Study Design

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

Study Groups

Treatment Arm

After inclusion, patients will receive conditioning chemotherapy consisting of non-investigational medicinal products (non-IMPs): fludarabine 25 mg/m2 from day -6 until day -2 (inclusive) and cyclophosphamide 500 mg/m2 on days -6 and -5.

Subsequently, patients in will be dosed with investigational medicinal product (IMP) OmnImmune® on day 0.

Group Type: EXPERIMENTAL

OmnImmune®

Intervention Type: BIOLOGICAL

infusion of OmnImmune® (expanded gamma delta T lymphocytes)

Interventions

OmnImmune®

infusion of OmnImmune® (expanded gamma delta T lymphocytes)

Intervention Type: BIOLOGICAL

Other Intervention Names

fludarabine; cyclophosphamide

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

1. AML relapse after intensive chemotherapy OR

2. AML relapse after allogeneic HCT OR

3. AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine) OR

4. No response to at least 4 cycles of low intensity therapy

5. 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. Age 18 years up to the age of 70 (≤ 70)

7. Life expectancy of at least 3 months

8. Karnofsky performance status ≥ 50%

9. Available related HLA-haploidentical or HLA-matched donor

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. Patient able to understand and sign written informed consent

Exclusion Criteria

1. Uncontrolled infections

2. Renal insufficiency: creatinine > 180 μmol/L or on dialysis

3. Heart failure: EF < 40%

4. Respiratory insufficiency: oxygen therapy required at inclusion in the study

5. Significant liver impairment: bilirubin > 50 μmol/L, AST or ALT > 4 times normal upper limit

6. Treatment with bisphosphonates (2 months before start)

7. Active autoimmune disease or GvHD

8. Pregnant or breastfeeding

9. Patient of fertile age not using two-barrier method of birth control.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Biopharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UHKT (Ustav hematologie a krevni transfuze)

Prague, , Czechia

Countries

Czechia

Other Identifiers

2018-000409-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TCB-202-001

Identifier Type: -

Identifier Source: org_study_id