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New treatment option for EBV-associated Hemophagocytic Lymphohistiocytosis
Official title Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
ClinicalTrials.gov ID: NCT06135922
What this study is testing
What is EBV-TCR-T cells?
EBV-TCR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ebv-associated hemophagocytic lymphohistiocytosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 60
You may be able to join if
- 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 1)Age \>=8 years, gender unlimited; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory...
You likely can't join if
- 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...
- Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
- Use of immunosuppressive drugs or G-CSF within 2 weeks before PBMC blood collection.
- Have tumours, active and uncontrolled malignant diseases.
- Serologically positive for HIV-Ab or TAP-ab.
See the full eligibility criteria
- 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 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...
- 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 or left...
- Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
- Use of immunosuppressive drugs or G-CSF within 2 weeks before PBMC blood collection.
- Have tumours, active and uncontrolled malignant diseases.
- Serologically positive for HIV-Ab or TAP-ab.
- Pregnant or lactating women.
- Men and their partners or women of childbearing potential refused contraception during the study period.
- 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.
- Allergy to albumin.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.