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

January 4, 2021 updated by: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • No.188 Shizi Street
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: γδT
γδT,Infusion,iv,0.5×10^6-8×10^7γδT /kg,once.
Drug: γδT Cell infusion agent
γδT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identification of the dose limiting toxicity (DLT)
Time Frame: 4 weeks after γδT infusion
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.
4 weeks after γδT infusion
The incidence of serious adverse events (SAEs)
Time Frame: 4 weeks after γδT infusion
The incidence of serious adverse events (SAEs) after γδT infusion
4 weeks after γδT infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease-free survival time(DFS)
Time Frame: about 2 years after γδT infusion
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
about 2 years after γδT infusion
Overall survival (OS)
Time Frame: about 2 years after γδT infusion
The time from the subject receiving γδT cell infusion treatment to death (for any reason)
about 2 years after γδT infusion
Duration of remission after administration (DOR)
Time Frame: about 2 years after γδT infusion
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
about 2 years after γδT infusion

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Soochow University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suning Chen, Ph.D, Hematology，The First Affiliaated Hospital Of Soochow University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PG-γδT-001

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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