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γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse (γδT)

Primary Purpose

Leukemia, B-cell

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
γδT Cell infusion agent
Sponsored by
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leukemia, B-cell focused on measuring γδT, leukemia

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute leukemia patients undergoing salvage allogeneic hematopoietic stem cell transplantation
  • Age 10-65,Any gender
  • Expected lifetime>3months
  • ECOG 0-2
  • DSA Negative
  • Successful granulocyte implantation
  • Liver and kidney function, heart and lung function meet the following requirements:①Creatinine≤1.5 ULN；②ALT/AST ≤5 ULN； ③Baseline oxygen saturation≥92%； ④Left ventricular ejection fraction≥50%
  • Female subjects with fertility who had a negative pregnancy test within 48 hours before the infusion and were not breastfeeding; all subjects with fertility potential before enrolling in the study and throughout the study period until the last infusion Within 3 months, take adequate contraceptive measures
  • Signing informed consent patients must be able to understand and be willing to participate in this study, and sign informed consent at the same time

Exclusion Criteria:

  • Donor HBsAg or HBcAb positive and HBV DNA titer test is not within the normal reference value; donor or patient HCV antibody positive and peripheral blood HCV RNA positive; donor or patient HIV antibody positive; donor syphilis test positive
  • Active central nervous system disease
  • BMI index>35
  • Allergic to DMSO
  • Graft-versus-host disease
  • Septic shock
  • Systemic steroid therapy is required during cell infusion or cell collection, or there are conditions that researchers believe may require steroid therapy during blood collection or during infusion. In addition to cell collection or infusion, steroids for disease treatment are allowed, and inhaled steroids or hydrocortisone are also allowed for physiological replacement therapy in patients with adrenal insufficiency
  • Participated in another clinical trial within 4 weeks before enrolling in the study, or intend to participate in another clinical trial throughout the study
  • According to the judgment of the investigator, it does not meet the situation of cell preparation
  • Circumstances considered by other researchers to be inappropriate

Sites / Locations

  • No.188 Shizi StreetRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

γδT

Arm Description

γδT,Infusion,iv,0.5×10^6-8×10^7γδT /kg,once.

Outcomes

Primary Outcome Measures

Identification of the dose limiting toxicity (DLT)
Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated.
The incidence of serious adverse events (SAEs)
The incidence of serious adverse events (SAEs) after γδT infusion

Secondary Outcome Measures

Disease-free survival time(DFS)
γδT cell infusion treatment of CR/CRi patients from the beginning of γδT cell infusion treatment to the first disease recurrence or death from any cause
Overall survival (OS)
The time from the subject receiving γδT cell infusion treatment to death (for any reason)
Duration of remission after administration (DOR)
γδT cell infusion treatment has not reached CR/CRi before the treatment, the time from the first assessment of CR/CRi after administration to the first assessment of disease recurrence or progression or death from any cause

Full Information

First Posted
June 16, 2020
Last Updated
January 4, 2021
Sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborators
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT04439721
Brief Title
γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse
Acronym
γδT
Official Title
Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborators
The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Detailed Description
γδT cells belong to the innate immune system and have a powerful anti-tumor effect. Leukemia patients transplanted with allogeneic hematopoietic stem cells have an important role in controlling leukemia recurrence. Although adoptive immunotherapy using in vitro expanded γδT cells has achieved significant results in patients with solid tumors, infusion of donor γδT cells in leukemia patients undergoing allogeneic hematopoietic stem cell transplantation to prevent leukemia recurrence has not been reported. . This clinical study intends to initially observe the safety and effectiveness of donor γδT cell infusion to prevent recurrence/refractory leukemia salvage allogeneic hematopoietic stem cell transplantation to further improve the transplantation effect of these patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, B-cell
Keywords
γδT, leukemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
γδT
Arm Type
Experimental
Arm Description
γδT,Infusion,iv,0.5×10^6-8×10^7γδT /kg,once.
Intervention Type
Drug
Intervention Name(s)
γδT Cell infusion agent
Intervention Description
γδT
Primary Outcome Measure Information:
Title
Identification of the dose limiting toxicity (DLT)
Description
Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated.
Time Frame
4 weeks after γδT infusion
Title
The incidence of serious adverse events (SAEs)
Description
The incidence of serious adverse events (SAEs) after γδT infusion
Time Frame
4 weeks after γδT infusion
Secondary Outcome Measure Information:
Title
Disease-free survival time(DFS)
Description
γδT cell infusion treatment of CR/CRi patients from the beginning of γδT cell infusion treatment to the first disease recurrence or death from any cause
Time Frame
about 2 years after γδT infusion
Title
Overall survival (OS)
Description
The time from the subject receiving γδT cell infusion treatment to death (for any reason)
Time Frame
about 2 years after γδT infusion
Title
Duration of remission after administration (DOR)
Description
γδT cell infusion treatment has not reached CR/CRi before the treatment, the time from the first assessment of CR/CRi after administration to the first assessment of disease recurrence or progression or death from any cause
Time Frame
about 2 years after γδT infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute leukemia patients undergoing salvage allogeneic hematopoietic stem cell transplantation Age 10-65,Any gender Expected lifetime>3months ECOG 0-2 DSA Negative Successful granulocyte implantation Liver and kidney function, heart and lung function meet the following requirements:①Creatinine≤1.5 ULN；②ALT/AST ≤5 ULN； ③Baseline oxygen saturation≥92%； ④Left ventricular ejection fraction≥50% Female subjects with fertility who had a negative pregnancy test within 48 hours before the infusion and were not breastfeeding; all subjects with fertility potential before enrolling in the study and throughout the study period until the last infusion Within 3 months, take adequate contraceptive measures Signing informed consent patients must be able to understand and be willing to participate in this study, and sign informed consent at the same time Exclusion Criteria: Donor HBsAg or HBcAb positive and HBV DNA titer test is not within the normal reference value; donor or patient HCV antibody positive and peripheral blood HCV RNA positive; donor or patient HIV antibody positive; donor syphilis test positive Active central nervous system disease BMI index>35 Allergic to DMSO Graft-versus-host disease Septic shock Systemic steroid therapy is required during cell infusion or cell collection, or there are conditions that researchers believe may require steroid therapy during blood collection or during infusion. In addition to cell collection or infusion, steroids for disease treatment are allowed, and inhaled steroids or hydrocortisone are also allowed for physiological replacement therapy in patients with adrenal insufficiency Participated in another clinical trial within 4 weeks before enrolling in the study, or intend to participate in another clinical trial throughout the study According to the judgment of the investigator, it does not meet the situation of cell preparation Circumstances considered by other researchers to be inappropriate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suning Chen, Ph.D
Phone
13814881746
Email
chensuning@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofei Yang, Ph.D
Phone
18962156841
Email
yangxiaofei1977@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suning Chen, Ph.D
Organizational Affiliation
Hematology，The First Affiliaated Hospital Of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
No.188 Shizi Street
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofei Yang, Ph.D
Phone
18962156841
Email
yangxiaofei1977@163.com

12. IPD Sharing Statement

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γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse

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