γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse

PersonGen BioTherapeutics

Status and phase

Unknown

Early Phase 1

Conditions

Leukemia, B-cell

Treatments

Drug: γδT Cell infusion agent

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04439721

PG-γδT-001

Details and patient eligibility

About

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

Full 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

Enrollment

5 estimated patients

Sex

All

Ages

10 to 65 years old

Volunteers

No 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