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Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04764513
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
42.6
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Ex-vivo expanded γδ T cell infusion
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.This dose escalation study will be conducted in two phases. The first phase will have 3 cohorts(Dose escalation, x5 dose increments between cohorts, 2×106、 1×107/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)
Primary Purpose:
Treatment
Official Title:
Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT. A Dose Escalation, Open-label, Phase 1/2 Study.
Actual Study Start Date :
Sep 12, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with hematological malignancies after allo-HSCT

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.

Biological: Ex-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.
Other Names:
  • Chemotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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 Outcome Measures

    1. 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).

    2. Overall Survival (OS) [Efficacy] [12 months post-treatment]

      Efficacy of ex-vivo expanded γδ T cell assessed by overall survival (OS) measured in months.

    3. 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'.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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;

    1. Life expectancy of at least 4 months;

    2. ECOG (Eastern Cooperative Oncology Group) score ≤ 2;

    3. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese PLA General Hospital Beijing China 100853

    Sponsors and Collaborators

    • Chinese PLA General Hospital

    Investigators

    • Principal Investigator: Chunji Gao, Professor, Chinese PLA General Hospital
    • Principal Investigator: Weidong Han, Professor, Chinese PLA General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Han weidong, Professor, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT04764513
    Other Study ID Numbers:
    • CHN-PLAGH-BT-062
    First Posted:
    Feb 21, 2021
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Hematologic Neoplasms
    Myelodysplastic Syndromes

    Study Results

    No Results Posted as of Mar 28, 2022