NCT06135922

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-associated hemophagocytic lymphohistiocytosis (EBV-HLH) or EBV infection

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
8mo left

Started Aug 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Aug 2023Dec 2026

Study Start

First participant enrolled

August 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 18, 2023

Status Verified

October 1, 2023

Enrollment Period

3.4 years

First QC Date

November 12, 2023

Last Update Submit

November 12, 2023

Conditions

EBV-associated Hemophagocytic LymphohistiocytosisEBV Infection

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Percentage of participants with adverse events

    1 year after EBV-TCR-T treatment

Secondary Outcomes (9)

  • Dose-limiting toxicity (DLT)

    28 days after EBV-TCR-T treatment

  • Maximum tolerated dose （MTD）

    28 days after EBV-TCR-T treatment

  • The proportion of EBV-DNA negative patients

    180 days after EBV-TCR-T treatment

  • The time to EBV-DNA negative

    180 days after EBV-TCR-T treatment

  • Changes of EBV-DNA copies number

    1 year after EBV-TCR-T treatment

  • +4 more secondary outcomes

Study Arms (1)

Experimental: EBV-TCR-T cells

EXPERIMENTAL

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

Biological: EBV-TCR-T cells

Interventions

EBV-TCR-T cellsBIOLOGICAL

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.

Experimental: EBV-TCR-T cells

Eligibility Criteria

Age1 Year - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify 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).

You may not qualify 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Daihong Liu, Doctor

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daihong Liu, Doctor

CONTACT

+86 18301339032daihongrm@163.com

Liping Dou, Doctor

CONTACT

+8613681207138lipingruirui@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 12, 2023

First Posted

November 18, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 18, 2023

Record last verified: 2023-10

Locations

CN(1)