T Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse

  • STATUS
    Recruiting
  • participants needed
    5
  • sponsor
    PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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Updated on 5 August 2020
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Summary

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

Description

T 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 T cells has achieved significant results in patients with solid tumors, infusion of donor T 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 T cell infusion to prevent recurrence/refractory leukemia salvage allogeneic hematopoietic stem cell transplantation to further improve the transplantation effect of these patients

Details
Condition Leukemia, B-Cell, Chronic Lymphocytic Leukemia, lymphocytic leukemia, chronic, Chronic Lymphocytic Leukemia, lymphocytic leukemia, chronic
Age 10years - 65years
Treatment γδT Cell infusion agent
Clinical Study IdentifierNCT04439721
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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:Creatinine1.5 ULNALT/AST 5 ULN Baseline oxygen saturation92% Left ventricular ejection fraction50%
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
Clear my responses
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