NCT06135922RecruitingPhase 1
Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
Source: ClinicalTrials.gov · Last updated 18 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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-associated hemophagocytic lymphohistiocytosis (EBV-HLH) or EBV infection
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 12 Nov 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Chinese PLA General Hospital
- NCT number
- NCT06135922
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 9
- From 1 Aug 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with uncontrolled active aGVHD one day before TCR-T cell infusion.
- Use of immunosuppressive drugs or G-CSF within 2 weeks before PBMC blood collection.
- 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 4 weeks of enrollment.
- TCRT-T cell donor exclusion criteria: 1) pregnant woman; 2) Serologically positive for HBsAg, HCV-Ab, HIV-Ab or TAP-ab; 3) EBV-DNA or CMV-DNA positive; 4) other uncontrolled infection; 5) Use of immunosuppressive drugs or G-CSF within 2 weeks before PBMC blood collection.
Other illness
- Have tumours, active and uncontrolled malignant diseases.
- Serologically positive for HIV-Ab or TAP-ab.
Lab values
- 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 or left ventricular ejection fraction\<50%) one week before TCR-T cell infusion.
- Allergy to albumin.
Other
- Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
- Pregnant or lactating women.
- Men and their partners or women of childbearing potential refused contraception during the study period.
Who the study is looking for
- Age 1-60 years, gender unlimited.
- Diagnosed with EBV associated-hemophagocytic lymphohistiocytosis (HLH) or EBV infection.
- Fully understood and informed the study and signed the ICF.
- Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age\<16y).
- TCRT-T cell donor inclusion criteria: 1)Age \>=8 years, gender unlimited; 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.
Age in the registry: 1 year to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.