- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02007356
A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System® (CCS)
A Phase I/II Single-center Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Nina Khanna, MD
- Phone Number: +41-61-2652525 (Zentrale)
- Email: nina.khanna@usb.ch
Study Locations
-
-
-
Basel, Switzerland, 4031
- Recruiting
- Universitätsspital Basel
-
Contact:
- Nina Khanna, Dr.
- Phone Number: 7325 0041-61-
- Email: nina.khanna@usb.ch
-
Principal Investigator:
- Nina Khanna, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults > 18 years of age
- Undergone allogeneic HSCT
- Written informed consent
- Patients with treatment refractory infections with adenovirus, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) will be included in case of fulfilling following criteria:
Patient with Adenovirus Infection:
Antiviral treatment with cidofovir for at least 7 days
- no virus load decrease ( ≤ 1 log) or virus load increase on treatment for at least 7 days or
- cluster of differentiation 3 (CD3) + cells < 300/µL on treatment for at least 7 days
- Or if antiviral treatment is contraindicated
Patient with EBV:
1. After receipt of at least one anti-cluster of differentiation 20 antigen (CD20)-antibody treat-ment (375 mg/m2)
- No Virus load decrease (≤ 1 log) or virus load increase 7 days after receipt of treatment or
- CD3+ cells < 300/µL 7 days after receipt of treatment or
- Clinical progression
Patient with CMV:
Antiviral treatment with ganciclovir or foscavir for 14 days
- No Virus load decrease (≤ 1 log) or virus load increase on day 14
- Or if > 2 recurrences despite antiviral treatment with ganciclovir or foscavir for 14 days and CD3+ cells < 300/µL
- Or if antiviral treatment is contraindicated -
Patient Exclusion Criteria:
- graft-versus-host disease (GVHD) > grade 2 at the time point of planned infusion
- Known allergy to iron-dextran or murine antibodies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: allogeneic HSCT
The present study will evaluate and validate in a single-center, open-label, single arm fashion the safety and feasibility of direct infusions of donor-derived pathogen-specific IFN-γ positive T-cells in recipients of HSCT with post-transplant viral infection according to the previously clinically certified CCS® [3-6]. The Investigator will first generate and apply IFN-γ positive selected T-cells to recipients of HSCT with CMV, EBV or adenovirus as previously published. The Investigator aim is to include 6 patients from the University Hospital of Basel. With confirmed safety the investigator will in the future perform an efficacy study and extend this treat-ment for other clinically relevant pathogens including human herpesvirus (HHV)-6, HHV-8, polyomaviruses JC and BK and fungi including Aspergillus fumigatus and Candida albicans, to other immunosuppressed patients such as solid organ transplant (SOT) recipients. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Level of enriched IFN-γ+ T-cells
Time Frame: 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment efficacy
Time Frame: 7 days
|
Treatment efficacy defined as reduction of virus load, in vivo expansion of antigen-specific T cells in peripheral blood as well as reduction of clinical signs of specific viral infection
|
7 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nina Khanna, Dr., Universitätsspital Basel, Klinik für Infektiologie
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKBB 205/13; me12Khanna
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cytomegalovirus Infections
-
University of Alabama at BirminghamEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingMaternal Cytomegalovirus Infections | Cytomegalovirus CongenitalUnited States
-
University of Sao Paulo General HospitalCompletedCytomegalovirus DiseaseBrazil
-
Mayo ClinicCompletedCytomegalovirus InfectionUnited States
-
Merck Sharp & Dohme LLCCompletedCytomegalovirus InfectionUnited States, France, Germany, Italy, Japan, United Kingdom
-
Assistance Publique - Hôpitaux de ParisCompletedCongenital Cytomegalovirus InfectionFrance
-
Merck Sharp & Dohme LLCCompletedCytomegalovirus (CMV) InfectionsUnited States, Australia, Canada, Finland, Israel, Russian Federation, Spain
-
National Institute of Allergy and Infectious Diseases...Terminated
-
Institut PasteurCompletedCongenital Cytomegalovirus InfectionFrance
-
Assistance Publique - Hôpitaux de ParisCompletedCongenital Cytomegalovirus InfectionFrance
-
The George Washington University Biostatistics...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedCongenital Cytomegalovirus Infection | Maternal Cytomegalovirus InfectionUnited States
Clinical Trials on IFN-γ positive selected T-cells
-
Yae-Jean KimMiltenyi Biotec B.V. & Co. KGWithdrawnCytomegalovirus InfectionsKorea, Republic of
-
Affiliated Hospital of Jiangnan UniversityWest China Hospital; Hunan Cancer Hospital; Shenzhen Second People's Hospital; Zhejiang... and other collaboratorsRecruitingPleural Effusion, MalignantChina
-
Mari DallasRecruitingAllogeneic Hematopoietic Stem Cell TransplantationUnited States
-
Shanghai Unicar-Therapy Bio-medicine Technology...The First Affiliated Hospital of Soochow UniversityRecruitingAcute Lymphoblastic Leukemia in RemissionChina
-
Nantes University HospitalCompletedAllergic Rhinitis | Atopic Dermatitis | Allergic AsthmaFrance
-
King's College LondonGuy's and St Thomas' NHS Foundation TrustRecruiting
-
Cell Medica LtdUniversity of Birmingham; Leukaemia Lymphoma Research; National Health Service...CompletedCytomegalovirus InfectionUnited Kingdom
-
Third Affiliated Hospital, Sun Yat-Sen UniversityShanghai Jiao Tong University School of MedicineUnknown
-
Baylor College of MedicineCancer Prevention Research Institute of Texas; The Methodist Hospital Research... and other collaboratorsActive, not recruiting
-
Thomas Martin, MDUniversity of California, Davis; Actavis Inc.; Eugia Pharma Specialities LimitedRecruitingRefractory Multiple Myeloma | Relapsed Multiple MyelomaUnited States