NCT06119256 Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
| NCT ID | NCT06119256 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chinese PLA General Hospital |
| Condition | EBV Infection After Allogenic HSCT |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2023-08-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Daihong Liu, Doctor
PRINCIPAL INVESTIGATOR
Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT06119256 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 75 Years, studying EBV Infection After Allogenic HSCT. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06119256 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06119256 currently recruiting?
Yes, NCT06119256 is actively recruiting participants. Contact the research team at daihongrm@163.com for enrollment information.
Where is the NCT06119256 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06119256 clinical trial?
NCT06119256 is sponsored by Chinese PLA General Hospital. The principal investigator is Daihong Liu, Doctor at Chinese PLA General Hospital. The trial plans to enroll 12 participants.