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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with hematological malignancies after allo-HSCT | Experimental |
After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ex-vivo expanded γδ T cell infusion | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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. | 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. | Day 28 after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months post-treatment |
| Overall Survival (OS) [Efficacy] |
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Inclusion Criteria:
Patients with hematological malignancies after allogeneic hematopoietic stem cell transplantation;
Age criteria: 18-65 years;
Weight criteria: > 40kg;
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;
Life expectancy of at least 4 months;
ECOG (Eastern Cooperative Oncology Group) score ≤ 2;
Patients able to understand and sign written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Wei, Master | Contact | +86-13146682665 | 13146682665@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunji Gao, Professor | Chinese PLA General Hospital | Principal Investigator |
| Weidong Han, Professor | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | 100853 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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Efficacy of ex-vivo expanded γδ T cell assessed by overall survival (OS) measured in months.
| 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'. | 12 months post-treatment |
| Persistence of γδ T cell | Persistence of γδ T cell assessed by number in peripheral blood. | Before treatment and up to 3 months after treatment |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |