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

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: Unknown
• Conditions: Leukemia, B-cell
• Intervention / Treatment: Drug: γδT Cell infusion agent

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: Interventional
• Enrollment (Anticipated): 5
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Suning Chen, Ph.D; Phone Number: 13814881746; Email: chensuning@sina.com
• Study Contact Backup: Name: Xiaofei Yang, Ph.D; Phone Number: 18962156841; Email: yangxiaofei1977@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • No.188 Shizi Street
      • Contact: Xiaofei Yang, Ph.D; Phone Number: 18962156841; Email: yangxiaofei1977@163.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	4 weeks after γδT infusion
The incidence of serious adverse events (SAEs)	The incidence of serious adverse events (SAEs) after γδT infusion	4 weeks after γδT infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	about 2 years after γδT infusion
Overall survival (OS)	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)	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

• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
• Collaborators: The First Affiliated Hospital of Soochow University
• Investigators: Principal Investigator: Suning Chen, Ph.D, Hematology，The First Affiliaated Hospital Of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: leukemia; γδT
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Leukemia, B-Cell
• Other Study ID 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