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

NCT03790072 | Completed Phase 1 DMC

• 2 other identifiers: TCB-202-0012018-000409-22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Myeloid Leukemia

Keywords

Gamma Delta T Lymphocytes

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (AEs) [Safety]

  Safety of OmnImmune® assessed by incidence of treatment-emergent adverse events (AEs) per patient graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  Day 28 after completion of treatment

• Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]

  Tolerability of OmnImmune® assessed by incidence of dose-limiting toxicities (DLTs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  Day 28 after completion of treatment

Secondary Outcomes (3)

• Number of patients reaching Complete Remission (CR) [Efficacy]

  24 months post-treatment

• Overall Survival (OS) [Efficacy]

  24 months post-treatment

• Quality of Life (QoL)

  24 months post-treatment

Other Outcomes (2)

• Persistence of γδ T cells

  Before treatment and up to 24 months after treatment

• Phenotype of γδ T cells

  Before treatment and up to 24 months after treatment

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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.

Biological: OmnImmune®

Interventions

OmnImmune® BIOLOGICAL

infusion of OmnImmune® (expanded gamma delta T lymphocytes)

Also known as: fludarabine, cyclophosphamide

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 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
• AML relapse after intensive chemotherapy OR
• AML relapse after allogeneic HCT OR
• AML progression on low intensity therapy (low dose cytarabine, 5-azacytidine or decitabine) OR
• No response to at least 4 cycles of low intensity therapy
• 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
• Age 18 years up to the age of 70 (≤ 70)
• Life expectancy of at least 3 months
• Karnofsky performance status ≥ 50%
• Available related HLA-haploidentical or HLA-matched donor
• 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.

You may not qualify if:

• Uncontrolled infections
• Renal insufficiency: creatinine \> 180 μmol/L or on dialysis
• Heart failure: EF \< 40%
• Significant liver impairment: bilirubin \> 50 μmol/L, AST or ALT \> 4 times normal upper limit
• Treatment with bisphosphonates (2 months before start)
• Active autoimmune disease or GvHD
• Pregnant or breastfeeding
• Patient of fertile age not using two-barrier method of birth control.

Sponsors & Collaborators

• TC Biopharm: lead

Study Sites (1)

UHKT (Ustav hematologie a krevni transfuze)

Prague, 128 20, Czechia

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

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

Model Details: Dose escalation, 3 cohorts, x10 dose increments between cohorts (10\^6, 10\^7, 10\^8 of cells per kg of body weight).

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 31, 2018
• Study Start: November 27, 2018
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

CZ (1)