Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell TransplantationEarly Phase 1NCT07476014
Early Clinical Study on the Use of Donor-derived EBV-specific T Cells for the Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation
A Early Phase 1 study testing JYEST Cell Injection Infusion in people with Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This study is a single-arm, open-label, dose-escalation and expansion, prospective clinical trial. Subjects will be recipients of allogeneic hematopoietic stem cell transplantation, with a planned enrollment of 9 to 18 subjects, to evaluate the safety and efficacy of JYEST cell injection for the prevention of EBV… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation
- What is being tested?
- JYEST Cell Injection Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2026to 27 Feb 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inclusion criteria for allogeneic hematopoietic stem cell transplantation shall be implemented in accordance with the regulations of the transplant center at the study site;
- Patients undergoing allogeneic hematopoietic stem cell transplantation with any of the following high-risk factors for EBV infection:
- EBV-DNA is positive in the recipient's or donor's serum, whole blood, PBMC or sorted cells before allogeneic hematopoietic stem cell transplantation;
- EBV-DNA is positive in the recipient's whole blood, PBMC or sorted cells after allogeneic hematopoietic stem cell transplantation, but EBV-DNA in plasma is negative;
- Allogeneic hematopoietic stem cell transplantation is performed due to treatment of EBV infectious diseases, including but not limited to: EBV-related lymphoma, chronic active EBV infection, EBV-related lymphoproliferative disorders, etc.;
- There is a history of EBV infection in the past, and allogeneic hematopoietic stem cell transplantation is required due to other malignant diseases.
- No age or gender restrictions;
- The subject and the guardian understand and sign the informed consent form.
Who cannot join
- The exclusion criteria for allogeneic hematopoietic stem cell transplantation shall be implemented in accordance with the regulations of the transplant center at the study site;
- Exclusion criteria before infusion of JYEST cell injection:
- Severe kidney disease (creatinine clearance rate less than 50% of the normal reference value for the same age group);
- Severe liver disease (TBil > 2.0×ULN; ALT and AST > 3.0×ULN);
- Severe acute infection (opportunistic infection);
- Expected survival period less than 6 weeks;
- Malnutrition (weight ≤ 10th percentile for the same age group, or serum albumin ≤ 3.0 g/dL);
- ECOG score > 2.
About this study
This study is a single-arm, open-label, dose-escalation and expansion, prospective clinical trial. Subjects will be recipients of allogeneic hematopoietic stem cell transplantation, with a planned enrollment of 9 to 18 subjects, to evaluate the safety and efficacy of JYEST cell injection for the prevention of EBV infection after allogeneic hematopoietic stem cell transplantation.
- Being tested
- JYEST Cell Injection Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYEST Cell Injection InfusionBiological
A "3+3" dose-escalation design with 3 dose cohorts: 5×10⁷, 1×10⁸, and 2×10⁸ cells.
dosage form: intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| JYEST Cell Injection Infusion | Experimental | JYEST cell injection infusion Receives: Biological: JYEST Cell Injection Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of dose-limiting toxicities (DLT) and adverse reactions
Measured: From CAR - T cell infusion to 28 days later
Secondary outcomes (1)
Incidence of Epstein-Barr virus (EBV) infection
Measured: From CAR - T cell infusion to 2 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start28 Feb 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion27 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476014
- Sponsor's protocol ID
- IIT2026009
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical Study on the Use of Donor-derived EBV-specific T Cells for the Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07476014
- Acronym / sponsor ID
- IIT2026009
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 27 Feb 2029 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, open-label, dose-escalation and expansion, prospective clinical trial. Subjects will be recipients of allogeneic hematopoietic stem cell transplantation, with a planned enrollment of 9 to 18 subjects, to evaluate the safety and efficacy of JYEST cell injection for the prevention of EBV infection after allogeneic hematopoietic stem cell transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JYEST Cell Injection Infusion | Experimental | Biological: JYEST Cell Injection InfusionJYEST cell injection infusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Inclusion criteria for allogeneic hematopoietic stem cell transplantation shall be implemented in accordance with the regulations of the transplant center at the study site;
- Patients undergoing allogeneic hematopoietic stem cell transplantation with any of the following high-risk factors for EBV infection:
- No age or gender restrictions;
- The subject and the guardian understand and sign the informed consent form.
Key exclusion criteria (8 listed)
- The exclusion criteria for allogeneic hematopoietic stem cell transplantation shall be implemented in accordance with the regulations of the transplant center at the study site;
- Exclusion criteria before infusion of JYEST cell injection:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JYEST Cell Injection InfusionA "3+3" dose-escalation design with 3 dose cohorts: 5×10⁷, 1×10⁸, and 2×10⁸ cells. dosage form: intravenous infusion. | Biological | JYEST Cell Injection Infusion |
Primary outcome
The incidence and severity of dose-limiting toxicities (DLT) and adverse reactions
Time frame: From CAR - T cell infusion to 28 days later
1 secondary outcome
Incidence of Epstein-Barr virus (EBV) infection
Time frame: From CAR - T cell infusion to 2 years later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing JYEST Cell Injection Infusion in people with Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation, run by Institute of Hematology & Blood Diseases Hospital, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of dose-limiting toxicities (DLT) and adverse reactions (time frame: From CAR - T cell infusion to 28 days later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.