Clinical trial NCT04439721: γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse
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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Leukemia, B-cell
Keywords: γδT
leukemia
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Soochow University
First posted: 2020-06-19
Enrollment: 5
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Identification of the dose limiting toxicity (DLT)
timeFrame: 4 weeks after γδT infusion
measure: The incidence of serious adverse events (SAEs)
timeFrame: 4 weeks after γδT infusion
Secondary outcomes:
measure: Disease-free survival time(DFS)
timeFrame: about 2 years after γδT infusion
measure: Overall survival (OS)
timeFrame: about 2 years after γδT infusion
measure: Duration of remission after administration (DOR)
timeFrame: about 2 years after γδT infusion
Other outcomes:
Locations:
city: Suzhou
country: China
facility: No.188 Shizi Street
state: Jiangsu
Study officials:
affiliation: Hematology，The First Affiliaated Hospital Of Soochow University
name: Suning Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: