This study investigates the infusion safety and potential curative properties of ex-vivo expanded γδ T cells obtained from the same donor for patients who have hematological malignancies and have accepted allogeneic hematopoietic stem cell transplantation.
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of ex-vivo expanded γδ T cell in patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation. γδ T cell will be separated from peripheral blood of the same donors. After expansion in vitro, they will be infused to the patients as an immunotherapy treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Phase 1: Patients receive ex-vivo expanded γδ T cell (Dose escalation, 3 cohorts, x5 dose increments between cohorts, 2×10\^6、 1×10\^7 and 5×10\^7 of cells per kg of body weight). Phase 2: Patients receive ex-vivo expanded γδ T cell at the maximum tolerated dose determined in Phase 1.
Chinese PLA General Hospital
Beijing, China
RECRUITINGIncidence of Treatment-Emergent Adverse Events (AEs)[Safety]
Safety of γδ T cell assessed by incidence of treatment-emergent adverse events (AEs) per patient graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Day 28 after completion of treatment
Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]
Tolerability of γδ T cell assessed by incidence of dose-limiting toxicities (DLTs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Day 28 after completion of treatment
Number of patients reaching Complete Remission (CR) [Efficacy]
Efficacy of ex-vivo expanded γδ T cell assessed by number of patients reaching Complete Remission (CR).
Time frame: 12 months post-treatment
Overall Survival (OS) [Efficacy]
Efficacy of ex-vivo expanded γδ T cell assessed by overall survival (OS) measured in months.
Time frame: 12 months post-treatment
Quality of Life (QoL)
Quality of life determined by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 'C30'.
Time frame: 12 months post-treatment
Persistence of γδ T cell
Persistence of γδ T cell assessed by number in peripheral blood.
Time frame: Before treatment and up to 3 months after treatment
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