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

NCT06491719 | Not Yet Recruiting

• 1 other identifier: 2024-P2-053-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Disease-free survival time (DFS)

  Assessment of CAEBV, EBV-HLH systemic disease status and peripheral blood EBV-DNA levels

  1 year

• complete remission rate (CR)

  EBV-DNA negative rate in relapsed/non-remitting patients

  1 year

• Recurrence rate (RT)

  EBV-DNA reactivation rate for high-risk patients

  1 year

Secondary Outcomes (2)

• cytomegalovirus DNA

  1 year

• Adverse Event（AE）

  1 year

Study Arms (1)

iNK cells infusion patients

EXPERIMENTAL

Given iNK cell infusion after allo HSCT

Other: NCR300（Allogenic Ipsc-derived Natural Killer cells ）

Interventions

NCR300（Allogenic Ipsc-derived Natural Killer cells ） 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.

iNK cells infusion patients

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• ≤65 years，ECOG :0-2；
• Cardiac EF≥40%, creatinine clearance ≥50%; aminotransferase（ALT/AST）\<200U/L。；
• In patients with HLH, HLH efficacy ≥Partial Response after prior treatment is required；
• Estimated survival time is longer than three months；
• Agree to sign the Informed Consent Form。

You may not qualify if:

• 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；
• Active infections other than EBV that have not yet been controlled；
• Positive for hepatitis B virus or hepatitis C virus；
• Active massive hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.)；
• Also participation in other interventional clinical studies within 4 weeks

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Syndrome; Lymphohistiocytosis, Hemophagocytic

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

zhao wang, MD

CONTACT

86010631383803; wangzhao@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: July 15, 2024
• Primary Completion: July 15, 2025
• Study Completion (Estimated): July 15, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)