Not Yet RecruitingNot Applicable

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

China15 participantsStarted 2024-07-15

Plain-language 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)

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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

What they're measuring

Disease-free survival time (DFS)

Timeframe: 1 year

complete remission rate (CR)

Timeframe: 1 year

Recurrence rate (RT)

Timeframe: 1 year

Trial details

NCT IDNCT06491719

SponsorBeijing Friendship Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-15

Contact for this trial

zhao wang, MD

86010631383803 wangzhao@ccmu.edu.cn

View on ClinicalTrials.gov More CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome trials

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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