Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EBV-TCR-T cells.
- Who it may be relevant to
- Registry conditions: EBV Infection After Allogenic HSCT. Basic parameters: 14 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
Overview
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.
Detailed description
EB virus (EBV) infection after allogeneic hematopoietic stem cell transplantation (HSCT) is common and can be lethal without prompt treatment. In this prospective study, HLA-A\*02:01/11:01/24:02-restricted EBV-specific T cell receptor (TCR) will be introduced into the T cells of HSCT donors by ex vivo lentiviral transduction to generate EBV-TCR-T cells. An escalated dose ranging from 3×10\^5/kg to 1×10\^6/kg of EBV-TCR-T cells will be infused into patients with EBV infection. The safety, efficacy, pharmacokinetics and cytokine levels of allogenic EBV-TCR-T cell therapy will be evaluated.
Interventions
- Biological EBV-TCR-T cells
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.
Primary outcome measures
- Adverse events [Time frame: 1 year after EBV-TCR-T treatment]
Secondary outcome measures (12)
- Changes of EBV-DNA copies number [Time frame: 1 year after EBV-TCR-T treatment]
- Persistence of EBV-TCR-T cells [Time frame: 1 year after EBV-TCR-T treatment]
- Dose-limiting toxicity [Time frame: 28 days after EBV-TCR-T treatment]
- Maximum tolerated dose [Time frame: 28 days after EBV-TCR-T treatment]
- The proportion of EBV-DNA negative patients [Time frame: 180 days after EBV-TCR-T treatment]
- The time to EBV-DNA negative [Time frame: 180 days after EBV-TCR-T treatment]
- The time to response [Time frame: 180 days after EBV-TCR-T treatment]
- The duration of response [Time frame: 1 year after EBV-TCR-T treatment]
- The incidence of EBV-PTLD [Time frame: 1 year after EBV-TCR-T treatment]
- The overall response rate to EBV-TCR-T treatment [Time frame: 28,90,180,365,730 days after EBV-TCR-T treatment]
- The complete response rate to EBV-TCR-T treatment [Time frame: 28,90,180,365, and 730 days after EBV-TCR-T treatment]
- The incidence of EBV reactivation after EBV-TCR-T treatment [Time frame: 1 year after EBV-TCR-T treatment]
Eligibility criteria
Inclusion criteria
- 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).
- TCR-T cell donor inclusion criteria: 1) Age 8-70 years; 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 recipients enrolled; 4) Lymphocyte count = (0.8\~4) × 10\^9/L; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT06119256 · S2022-083-01