Early Clinical Study on the Use of Donor-derived EBV-spec... | NCT07476014

Studies
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

NCT07476014

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Status

Not yet recruiting

Last Update Posted

Mar 17, 2026Actual

Enrollment

18Estimated

Phase

Early Phase 1

Conditions

Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

JYEST Cell Injection Infusion

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2026Estimated

Primary Completion Date

Jan 1, 2029Estimated

Completion Date

Feb 27, 2029Estimated

First Submitted Date

Mar 12, 2026

First Submission Date that Met QC Criteria

Mar 12, 2026

First Posted Date

Mar 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2026

Last Update Posted Date

Mar 17, 2026Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JYEST Cell Injection Infusion	Experimental	JYEST cell injection infusion	Biological: JYEST Cell Injection Infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JYEST Cell Injection Infusion	Biological	A "3+3" dose-escalation design with 3 dose cohorts: 5×10⁷, 1×10⁸, and 2×10⁸ cells. dosage form: intravenous infusion.	JYEST Cell Injection Infusion

Measure	Description	Time Frame
The incidence and severity of dose-limiting toxicities (DLT) and adverse reactions		From CAR - T cell infusion to 28 days later

Measure	Description	Time Frame
Incidence of Epstein-Barr virus (EBV) infection		From CAR - T cell infusion to 2 years later

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:
1. EBV-DNA is positive in the recipient's or donor's serum, whole blood, PBMC or sorted cells before allogeneic hematopoietic stem cell transplantation;
2. 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;
3. 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.;
4. 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.

Exclusion Criteria:

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:
1. Severe kidney disease (creatinine clearance rate less than 50% of the normal reference value for the same age group);
2. Severe liver disease (TBil > 2.0×ULN; ALT and AST > 3.0×ULN);
3. Severe acute infection (opportunistic infection);
4. Expected survival period less than 6 weeks;
5. Malnutrition (weight ≤ 10th percentile for the same age group, or serum albumin ≤ 3.0 g/dL);
6. ECOG score > 2.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided