What is EBV-TCR-T cell therapy studying for EBV-associated hemophagocytic lymphohistiocytosis or EBV infection?

This trial is studying how EBV-TCR-T cell therapy works in treating EBV-associated hemophagocytic lymphohistiocytosis or EBV infection. Researchers aim to understand its safety, effectiveness, and how the cells behave in the body. The study is led by the Chinese PLA General Hospital to explore this new treatment option.

Who may be eligible for this EBV-associated hemophagocytic lymphohistiocytosis clinical trial?

People aged 1 to 60 years diagnosed with EBV-associated hemophagocytic lymphohistiocytosis or EBV infection may be eligible. Both males and females can join if they meet health criteria such as adequate organ function and no recent immunosuppressive drug use. Please review eligibility criteria for more details.

Is there any cost to participate in this EBV-associated hemophagocytic lymphohistiocytosis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal expenses like travel or accommodation may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 1Year - 60Years

All Genders

ID06135922

Phase 1 Study of EBV-TCR-T Cell Therapy for Treating EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection in Patients Aged 1 to 60

Led by Chinese PLA General Hospital · Updated on 2023-11-18

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and effectiveness of EBV-TCR-T cell immunotherapy in patients with Epstein-Barr virus EBV-associated hemophagocytic lymphohistiocytosis EBV-HLH or EBV infection. This phase I, multi-center, open-label trial aims to understand how well this treatment works and its safety profile. EBV is a common herpesvirus that can cause serious complications like EBV-positive B-cell lymphomas and chronic infections when not controlled. The treatment involves creating EBV-specific T cell receptor TCR T cells by introducing a restricted EBV-specific TCR into donor T cells using lentiviral transduction. Patients with EBV-HLH or EBV infection will receive infusions of these EBV-TCR-T cells in escalating doses ranging from 1106kg to 1108kg. The trial is designed as a single-arm study where all participants receive the investigational EBV-TCR-T cell therapy. Participants will be monitored for adverse events for up to one year after treatment. The study will also assess dose-limiting toxicity, maximum tolerated dose, changes in EBV-DNA levels, and pharmacokinetics of the EBV-TCR-T cells. Regular evaluations include measuring cytokine levels, viral DNA copies, and cell concentration over time to understand treatment effects and safety. The total study duration and follow-up last through one year post-treatment.

CONDITIONS

Brief Title

Clinical Study of EBV-TCR-T Cells for EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection

Who Can Participate

Age: 1Year - 60Years

All Genders

Eligibility Criteria

You may qualify if you...

Age between 1 and 60 years, any gender
Diagnosed with EBV-associated hemophagocytic lymphohistiocytosis (HLH) or EBV infection
Fully informed about the study and signed the informed consent form
Karnofsky Score 70 or higher for those 16 years or older, or Lansky Score 50 or higher for those under 16 years
TCR-T cell donors must be 8 years or older, understand the study, sign consent, have at least 3 out of 6 HLA matches with recipients, have normal lymphocyte counts (0.8 to 4 x 10^9/L), and have sufficient venous access without symptoms preventing blood collection

You will not qualify if you...

Uncontrolled active acute graft-versus-host disease (aGVHD) one day before infusion
Severe kidney disease (creatinine over 3 times normal), liver damage (total bilirubin over 2.5 times normal, ALT and AST over 3 times normal), or heart failure (NYHA grade IV or ejection fraction below 50%) within one week before infusion
Expected to take immunosuppressive hormones on infusion day
Use of immunosuppressive drugs or G-CSF within 2 weeks before blood collection
Presence of tumors or uncontrolled malignant diseases
Positive for HIV antibodies or TAP antibodies
Pregnant or breastfeeding women
Men and women of childbearing potential who refuse contraception during the study
Expected to receive other cell therapies within 4 weeks after infusion
Participation in other clinical drug or device studies within 4 weeks before enrollment
Allergy to albumin
TCR-T cell donors who are pregnant; positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or TAP antibody; positive for EBV-DNA or CMV-DNA; have uncontrolled infections; or have used immunosuppressive drugs or G-CSF within 2 weeks before blood collection

Research Team

Daihong Liu, Doctor

Liping Dou, Doctor

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Phase 1 Study of EBV-TCR-T Cell Therapy for Treating EBV-associated Hemophagocytic Lymphohistiocytosis or EBV Infection in Patients Aged 1 to 60

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria