EBV Infection After Allogenic HSCTPhase 1NCT06119256
Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
A Phase 1 study testing EBV-TCR-T cells in people with EBV Infection After Allogenic HSCT, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- EBV Infection After Allogenic HSCT
- What is being tested?
- EBV-TCR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Liping Dou, Doctor contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Daihong Liu, Doctor, 86-13681171597, daihongrm@163.com
Liping Dou, Doctor, 86-13681207138, lipingruirui@163.com
About this study
Official title: Multicenter, Open Label, Single-arm Exploratory Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT
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.
Read the 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.
- Conditions
- EBV Infection After Allogenic HSCT
- Being tested
- EBV-TCR-T cells
- Keywords
- EBV infection, allogenic HSCT
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBV-TCR-T cellsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: EBV-TCR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Percentage of participants with adverse events.
Measured: 1 year after EBV-TCR-T treatment
Secondary outcomes (18)
Changes of EBV-DNA copies number
Quantitative PCR will be used to determine viral copy numbers in peripheral blood.
Measured: 1 year after EBV-TCR-T treatment
Persistence of EBV-TCR-T cells
Quantitative PCR using primers specific for the gene encoding EBV-TCR will be used to determine the number of circulating EBV-TCR-T cells in peripheral blood post infusion.
Measured: 1 year after EBV-TCR-T treatment
Dose-limiting toxicity
Toxic effects considered by the investigators to be related to the EBV-TCR-T
Measured: 28 days after EBV-TCR-T treatment
Maximum tolerated dose
The highest dose of DLT was seen in 1/6 of the subjects
Measured: 28 days after EBV-TCR-T treatment
The proportion of EBV-DNA negative patients
The proportion of patients EBV-DNA negative after EBV-TCR-T treatment
Measured: 180 days after EBV-TCR-T treatment
The time to EBV-DNA negative
The time from the start of therapy to EBV-DNA negative detected
Measured: 180 days after EBV-TCR-T treatment
The time to response
The time from the start of therapy to the time when patients firstly achieve complete remission or partial remission
Measured: 180 days after EBV-TCR-T treatment
The duration of response
The time from the patients firstly achieve complete remission or partial remission to progression of disease
Measured: 1 year after EBV-TCR-T treatment
The incidence of EBV-PTLD
The incidence of EBV-PTLD after EBV-TCR-T treatment
Measured: 1 year after EBV-TCR-T treatment
The overall response rate to EBV-TCR-T treatment
The overall response rate to EBV-TCR-T treatment
Measured: 28,90,180,365,730 days after EBV-TCR-T treatment
The complete response rate to EBV-TCR-T treatment
The complete response rate to EBV-TCR-T treatment
Measured: 28,90,180,365, and 730 days after EBV-TCR-T treatment
The incidence of EBV reactivation after EBV-TCR-T treatment
The incidence of EBV reactivation after EBV-TCR-T treatment
Measured: 1 year after EBV-TCR-T treatment
Maximum Plasma Concentration (Cmax) of EBV-TCR-T cells
Pharmacokinetic (PK) parameters of EBV-TCR-T cells in patients with EBV reactivation
Measured: 28 days after EBV-TCR-T treatment
Area under the plasma concentration versus time curve (AUC) of EBV-TCR-T cells
Pharmacokinetic (PK) parameters of EBV-TCR-T cells in patients with EBV reactivation
Measured: 28 days after EBV-TCR-T treatment
Half life time (T1/2) of EBV-TCR-T cells
Pharmacokinetic (PK) parameters of EBV-TCR-T cells in patients with EBV reactivation
Measured: 28 days after EBV-TCR-T treatment
Concentration levels of cytokines
Concentration levels of cytokines (IL-2, IL-6, IL-10, TNF-α, IFN-γ)
Measured: 28 days after EBV-TCR-T treatment
Concentration levels of CRP
Pharmacokinetics of EBV-TCR-T cells
Measured: 28 days after EBV-TCR-T treatment
Concentration levels of ferritin
Pharmacokinetics of EBV-TCR-T cells
Measured: 28 days after EBV-TCR-T treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV Infection After Allogenic HSCTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daihong Liu, Chinese PLA General Hospital
- Investigators
- Daihong Liu, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119256
- Sponsor's protocol ID
- S2022-083-01
- Status last verified
- Mar 2026
- First submitted
- 21 Oct 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No