Status:
RECRUITING
Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
EBV Infection After Allogenic HSCT
Eligibility:
All Genders
14-75 years
Phase:
PHASE1
Brief Summary
This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of EBV-TCR-T cell immunotherapy in treating EBV virus infection after allogenic HSCT.
Detailed Description
EB virus (EBV) infection after allogeneic hematopoietic stem cell transplantation (HSCT) is common and can be lethal without prompt treatment. In this prospective study, HLA-A\*02:01/11:01/24:02-restr...
Eligibility Criteria
Inclusion
- Age 14-75 years, gender unlimited.
- Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with EBV infection after allo-HSCT.
- Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age\<16y).
- TCR-T cell donor inclusion criteria: 1) Age 8-70 years; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3/6 HLA match with TCR-T cell recipients enrolled; 4) Lymphocyte count = (0.8\~4) × 10\^9/L; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.
Exclusion
- Patients with uncontrolled active aGVHD one day before TCR-T cell infusion.
- Patients with severe kidney disease (Cr \> 3×normal value), liver damage (TBIL \>2.5×upper limit of normal value, ALT and AST \> 3×upper limit of normal value) or heart failure (NYHA heart function grade IV) one week before TCR-T cell infusion.
- Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
- Have other malignancies.
- Have relapsed and uncontrolled hematologic malignancies.
- Serologically positive for HIV-Ab or TAP-ab.
- Pregnant or lactating women.
- Anticipated to have other cell therapies in 4 week post TCR-T cell infusion.
- Participated in any other clinical study of drugs and medical devices before 30 days of enrollment.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06119256
Start Date
August 1 2023
End Date
December 31 2026
Last Update
November 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853