Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoma, Myelodysplastic Syndromes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALEx-vivo expanded γδ T cell infusion
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.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This dose escalation study will be conducted in two phases. The first phase will have 3 cohorts(Dose escalation, x5 dose increments between cohorts, 2×10\^6、 1×10\^7/kg and 5×10\^7 of cells per kg of body weight). The second phase is an expansion cohort at the maximum tolerated dose determined in the first phase.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation； 2. Age criteria: 18-65 years; 3. Weight criteria: \> 40kg; 4. Organ function criteria: Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%, Pulmonary function: Indoor oxygen saturation≥95%, Alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN (upper limit of normal value), Total bilirubin ≤ 1.5×ULN, Serum creatinine ≤ 1.5×ULN; 5. Life expectancy of at least 4 months; 6. ECOG (Eastern Cooperative Oncology Group) score ≤ 2; 7. Patients able to understand and sign written informed consent.
Exclusion criteria
1. GVHD (graft versus host disease) ≥ grade Ⅱ； 2. Thrombotic microangiopathy； 3. Posttransplant lymphoproliferative disorders； 4. Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)； 5. Patients with chronic diseases that require treatment with immune agents or hormones; 6. Suffering from systemic autoimmune disease or immunodeficiency disease; 7. Systemic use of steroids; 8. Allergic constitution; 9. Hemorrhagic disease or coagulation disorders; 10. Patients participating in other clinical trials within 30 days prior to enrollment; 11. Patients receiving radiotherapy within 4 weeks prior to enrollment; 12. Pregnant or breastfeeding women; 13. According to the researcher's judgment, the patient has other unsuitable conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (AEs)[Safety] | Day 28 after completion of treatment | 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. |
| Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability] | Day 28 after completion of treatment | Tolerability of γδ T cell assessed by incidence of dose-limiting toxicities (DLTs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients reaching Complete Remission (CR) [Efficacy] | 12 months post-treatment | Efficacy of ex-vivo expanded γδ T cell assessed by number of patients reaching Complete Remission (CR). |
| Overall Survival (OS) [Efficacy] | 12 months post-treatment | Efficacy of ex-vivo expanded γδ T cell assessed by overall survival (OS) measured in months. |
| Quality of Life (QoL) | 12 months post-treatment | Quality of life determined by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 'C30'. |
| Persistence of γδ T cell | Before treatment and up to 3 months after treatment | Persistence of γδ T cell assessed by number in peripheral blood. |
Countries
China
Contacts
Primary ContactYan Wei, Master
Outcome results
None listed