Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection
NCT ID: NCT06135922
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
9 participants
INTERVENTIONAL
2023-08-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: EBV-TCR-T cells
The patients with EBV-HLH or EBV infection will receive infusions of EBV-TCR-T cells, with the escalated dose ranging from 1×10\^6/kg to 1×10\^8/kg EBV-TCR-T cells per dose
EBV-TCR-T cells
The patients with EBV-HLH or EBV infection will receive infusions of EBV-TCR-T cells, with the escalated dose ranging from 1×10\^6/kg to 1×10\^8/kg EBV-TCR-T cells per dose.
Interventions
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EBV-TCR-T cells
The patients with EBV-HLH or EBV infection will receive infusions of EBV-TCR-T cells, with the escalated dose ranging from 1×10\^6/kg to 1×10\^8/kg EBV-TCR-T cells per dose.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
* 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.
1 Year
60 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Daihong Liu
Director
Principal Investigators
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Daihong Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S2022-381-01
Identifier Type: -
Identifier Source: org_study_id
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