Trials / Completed
CompletedNCT03790072
Ex-vivo Expanded γδ T-lymphocytes (OmnImmune®) in Patients With Acute Myeloid Leukaemia (AML)
Safety and Efficacy of Ex-vivo Expanded Allogeneic γδ T-lymphocytes (OmnImmune®) in Patients With Active Relapsed or Refractory Acute Myeloid Leukaemia (AML) Who Are Not Eligible for or do Not Consent to High Dose Salvage Chemotherapy and/or Allogeneic Haematopoietic Cell Transplantation (HCT). A Dose Escalation, Open-label, Phase I Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- TC Biopharm · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | OmnImmune® | infusion of OmnImmune® (expanded gamma delta T lymphocytes) |
Timeline
- Start date
- 2018-11-27
- Primary completion
- 2021-03-26
- Completion
- 2021-03-26
- First posted
- 2018-12-31
- Last updated
- 2021-03-30
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT03790072. Inclusion in this directory is not an endorsement.