A Study on Efficacy and Safety of iNK Cells for CAEBV /EBV-HLH After Allo-HSCT

NCT ID: NCT06491719

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2026-07-15

Brief Summary

To evaluate the efficacy and safety of iNK cells infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)

Detailed Description

It is a prospective, open-lable study to evaluate the efficacy and safety of iNK cell infusion in CAEBV/EBV-HLH patients after allo-HSCT. The study will enroll fifteen subjects who will receive ongoing least 4 doses of iNK cells intravenously infusion after allogeneic hematopoietic stem cell transplantation. All subjects will assess the incidence of disease relapse and EBV-DNA reactivation up to one year.

Conditions

CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome; EBV; Hemophagocytic Lymphohistiocytoses

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iNK cells infusion patients

Given iNK cell infusion after allo HSCT

Group Type: EXPERIMENTAL

NCR300（Allogenic Ipsc-derived Natural Killer cells ）

Intervention Type: OTHER

Patients will receive iNK cells i.V. infusion at 1.0x10^8/kg on days +14d, +21d, +28d, and +35d post-transplant.

Continuation of the infusion after +35d post-transplant is at the discretion of the physician based on the patient's benefit.

Interventions

NCR300（Allogenic Ipsc-derived Natural Killer cells ）

Patients will receive iNK cells i.V. infusion at 1.0x10^8/kg on days +14d, +21d, +28d, and +35d post-transplant.

Continuation of the infusion after +35d post-transplant is at the discretion of the physician based on the patient's benefit.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with CAEBV or EBV-HLH who are eligible for allogeneic hematopoietic stem cell transplantation meet one of the following criteria:

①EBV-DNA (PBMC or plasma) was still more than 103 before transplantation；②Positive for Cerebrospinal fluid EBV-DNA；

③Abnormal phenotypic lymphocytes could still be detected in bone marrow immunotyping；

④Measurable EBV-related lesions on imaging；

2. ≤65 years，ECOG :0-2；

3. Cardiac EF≥40%, creatinine clearance ≥50%; aminotransferase（ALT/AST）<200U/L。；

4. In patients with HLH, HLH efficacy ≥Partial Response after prior treatment is required；

5. Estimated survival time is longer than three months；

6. Agree to sign the Informed Consent Form。

Exclusion Criteria

1. Patients with evidence of grade II or more serious heart disease according to the New York Heart Association (NYHA) score (including Grade II) ; Clear diagnosis of cirrhosis；

2. Active infections other than EBV that have not yet been controlled；

3. Positive for hepatitis B virus or hepatitis C virus；

4. Active massive hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.)；

5. Also participation in other interventional clinical studies within 4 weeks

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Countries

China

Central Contacts

zhao wang, MD

Role: CONTACT

wangzhao@ccmu.edu.cn

86010631383803

Other Identifiers

2024-P2-053-02

Identifier Type: -

Identifier Source: org_study_id