Back to resultsSafety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT
Primary Purpose
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ex-vivo expanded γδ T cell infusion
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
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:
- GVHD (graft versus host disease) ≥ grade Ⅱ；
- Thrombotic microangiopathy；
- Posttransplant lymphoproliferative disorders；
- Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)；
- Patients with chronic diseases that require treatment with immune agents or hormones;
- Suffering from systemic autoimmune disease or immunodeficiency disease;
- Systemic use of steroids;
- Allergic constitution;
- Hemorrhagic disease or coagulation disorders;
- Patients participating in other clinical trials within 30 days prior to enrollment;
- Patients receiving radiotherapy within 4 weeks prior to enrollment;
- Pregnant or breastfeeding women;
- According to the researcher's judgment, the patient has other unsuitable conditions.
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with hematological malignancies after allo-HSCT
Arm Description
Patients with negative minimal residual disease or stable disease: After inclusion, patients will receive or not receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. Patients with positive minimal residual disease but not hematologic relapse: After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell. Patients with hematologic relapse: After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
Overall Survival (OS) [Efficacy]
Efficacy of ex-vivo expanded γδ T cell assessed by overall survival (OS) measured in months.
Quality of Life (QoL)
Quality of life determined by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 'C30'.
Persistence of γδ T cell
Persistence of γδ T cell assessed by number in peripheral blood.
Full Information
NCT ID
NCT04764513
First Posted
February 19, 2021
Last Updated
March 24, 2022
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04764513
Brief Title
Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT
Official Title
Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT. A Dose Escalation, Open-label, Phase 1/2 Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with hematological malignancies after allo-HSCT
Arm Type
Experimental
Arm Description
Patients with negative minimal residual disease or stable disease:
After inclusion, patients will receive or not receive chemotherapy. Subsequently, patients will be dosed with γδ T cell.
Patients with positive minimal residual disease but not hematologic relapse:
After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell.
Patients with hematologic relapse:
After inclusion, patients will receive chemotherapy. Subsequently, patients will be dosed with γδ T cell.
Intervention Type
Biological
Intervention Name(s)
Ex-vivo expanded γδ T cell infusion
Other Intervention Name(s)
Chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (AEs)[Safety]
Description
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
Title
Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]
Description
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
Secondary Outcome Measure Information:
Title
Number of patients reaching Complete Remission (CR) [Efficacy]
Description
Efficacy of ex-vivo expanded γδ T cell assessed by number of patients reaching Complete Remission (CR).
Time Frame
12 months post-treatment
Title
Overall Survival (OS) [Efficacy]
Description
Efficacy of ex-vivo expanded γδ T cell assessed by overall survival (OS) measured in months.
Time Frame
12 months post-treatment
Title
Quality of Life (QoL)
Description
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
Title
Persistence of γδ T cell
Description
Persistence of γδ T cell assessed by number in peripheral blood.
Time Frame
Before treatment and up to 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
GVHD (graft versus host disease) ≥ grade Ⅱ；
Thrombotic microangiopathy；
Posttransplant lymphoproliferative disorders；
Uncontrolled infection or other uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)；
Patients with chronic diseases that require treatment with immune agents or hormones;
Suffering from systemic autoimmune disease or immunodeficiency disease;
Systemic use of steroids;
Allergic constitution;
Hemorrhagic disease or coagulation disorders;
Patients participating in other clinical trials within 30 days prior to enrollment;
Patients receiving radiotherapy within 4 weeks prior to enrollment;
Pregnant or breastfeeding women;
According to the researcher's judgment, the patient has other unsuitable conditions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Wei, Master
Phone
+86-13146682665
Email
13146682665@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunji Gao, Professor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weidong Han, Professor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Wei, Master
Phone
+86-13146682665
Email
13146682665@163.com
First Name & Middle Initial & Last Name & Degree
Chunji Gao, Professor
Phone
+86-13911536256
Email
gaochunji301@163.com
12. IPD Sharing Statement
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Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT
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