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

March 24, 2022 updated by: Han weidong, Chinese PLA General Hospital

Safety and Efficiency of γδ T Cell Against Hematological Malignancies After Allo-HSCT. A Dose Escalation, Open-label, Phase 1/2 Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with hematological malignancies after allo-HSCT

  1. 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.

  2. 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.

  3. 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (AEs)[Safety]
Time Frame: 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.
Day 28 after completion of treatment
Incidence of Dose-Limiting Toxicities (DLTs) [Tolerability]
Time Frame: 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.
Day 28 after completion of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients reaching Complete Remission (CR) [Efficacy]
Time Frame: 12 months post-treatment
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]
Time Frame: 12 months post-treatment
Efficacy of ex-vivo expanded γδ T cell assessed by overall survival (OS) measured in months.
12 months post-treatment
Quality of Life (QoL)
Time Frame: 12 months post-treatment
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
Time Frame: Before treatment and up to 3 months after treatment
Persistence of γδ T cell assessed by number in peripheral blood.
Before treatment and up to 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 12, 2021

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

April 1, 2025

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (ACTUAL)

February 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHN-PLAGH-BT-062

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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