Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT

NCT06119256 | Recruiting Phase 1 DMC

• 1 other identifier: S2022-083-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

EBV Infection After Allogenic HSCT

Keywords

EBV infection; allogenic HSCT

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Percentage of participants with adverse events.

  1 year after EBV-TCR-T treatment

Secondary Outcomes (18)

• Changes of EBV-DNA copies number

  1 year after EBV-TCR-T treatment

• Persistence of EBV-TCR-T cells

  1 year after EBV-TCR-T treatment

• Dose-limiting toxicity

  28 days after EBV-TCR-T treatment

• Maximum tolerated dose

  28 days after EBV-TCR-T treatment

• The proportion of EBV-DNA negative patients

  180 days after EBV-TCR-T treatment

Study Arms (1)

EBV-TCR-T cells

EXPERIMENTAL

Phase 1 trail: The patients with EBV infection after HSCT will receive one to three infusions of donor-derived EBV-TCR-T cells, with the escalated dose ranging from 5×10\^5/kg to 1×10\^6/kg EBV-TCR-T cells per dose. Phase 2 trail: According to the PK and response data, the dose escalation phase will be carried out.

Biological: EBV-TCR-T cells

Interventions

EBV-TCR-T cells BIOLOGICAL

The patients with EBV infection after HSCT will receive one to three infusions of donor-derived EBV-TCR-T cells, with the escalated dose ranging from 5×10\^5/kg to 1×10\^6/kg EBV-TCR-T cells per dose.

EBV-TCR-T cells

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

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) 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Daihong Liu, Doctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daihong Liu, Doctor

CONTACT

+86 18301339032; daihongrm@163.com

Liping Dou, Doctor

CONTACT

+86 13681207138

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: October 21, 2023
• First Posted: November 7, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (1)