- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04344548
Adoptive Cell Transfer for the Immunotherapy of COVID-19 in Colombia
Phase I / II Clinical Study of Immunotherapy Based on Adoptive Cell Transfer as a Therapeutic Alternative for Patients With COVID-19 in Colombia
Immunotherapy based on Adoptive Cellular Transfer (ACT) uses several types of immune cells, including dendritic cells, cytotoxic T lymphocytes, lymphokine-activated killer cells, and NK cells. NK cell-based immunotherapies are an attractive approach for treating diseases because of their characteristic recognition and killing mechanisms; they are involved in the early defense against infectious pathogens and against MHC class-I-negative or -low-expressing targets without the requirement for prior immune sensitization of the host and are able to lyse target through the release of perforin and granzymes and using antibody-dependent cellular cytotoxicity pathways mediated by Fc receptor for IgG (CD16).
The aim of this project is to evaluate the safety and immunogenicity of allogeneic NK cells from peripheral blood mononuclear cells (PBMCs) of healthy donors in patients infected with COVID-19 collected by apheresis. This allows us to collect cGMP PBMCs and immunomagnetic remove several types of undesirable cells including B, T and CD33+ cells with enrichment of NK cells that will be expanded in bioreactors with GMP culture media (AIM-V) supplemented with human AB serum and GMP grade IL-2, and IL-15. After quality control verification the final NK cell product will be resuspended in 300 mL saline solution for intravenous infusion. Initially, we will enroll in this study ten COVID-19 infected adult patients with moderate symptoms (NEWS 2 scale score>4). Consent forms will be signed by the patient before the therapy. Patients will be treated with three different infusions of NK cells 48 h apart with 1, 10, and 20 million cells/kg body weight. We will follow the patients for any adverse effect, clinical response and immune effects by flow cytometry including markers for NK cells expressing different markers (CD158b, NKG2A, and IFN-y). We anticipated that the release of IFN-y by exogenous NK cells could attract other immune cell populations to boost the immune response against COVID-19.
Study Overview
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Bogotá Distrito Capital
-
Bogotá, Bogotá Distrito Capital, Colombia, 111321
- Fundacion Salud De Los Andes
-
-
Cundinamarca
-
Bogota, Cundinamarca, Colombia, 111321
- Universidad Nacional de Colombia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years at the time of the evaluation
- Able and willing to understand the study, follow all study procedures, and provide written informed consent.
- Initial diagnosis of COVID-19 disease as defined by a molecular diagnostic test approved by the National Institute of Health positive for SARS-CoV-2
- Clinical presentation of moderate or severe (identified at the time of admission to the room by the National Early Warning Score NEWS-2; moderate >4)
Exclusion Criteria:
- Patients who are hospitalized for inpatient treatment or are currently being evaluated for possible hospitalization at the time of informed consent initiation.
- Oxygen saturation in ambient air of <92%
- History of Chronic Obstructive Pulmonary Disease (COPD)
- Participation in a clinical trial with or use of any investigational agent within 30 days prior to detection, or treatment with interferons (IFN) or immunomodulators within 12 months prior to detection
- Pregnant or lactating female patients.
- Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma
- Co-infected with the human immunodeficiency virus (HIV) or the hepatitis C virus (HCV)
- Significant abnormal laboratory test results on screening.
- Significant concurrent diseases and other comorbidities that may require intervention during the study.
- Concurrent use of any of the following medications: Therapy with an immunomodulatory agent. Current use of heparin o Coumadin. Received blood products within 30 days prior to study randomization. Use of hematological growth factors within 30 days prior to the randomization of the study. Any recipe or herbal product that is not approved by the researcher. Long-term treatment (> 2 weeks) with agents that have a high risk of nephrotoxicity or hepatotoxicity unless approved by the medical monitor. Receiving systemic immunosuppressive therapy within 3 months prior to detection.
- Considered by researchers to be unfit to participate in this clinical trial
- Chronic heart failure with ejection fraction less than 30%.
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: Treatment group
Adult patients with COVID-19 infection with NEWS 2 score >4
|
Three doses of allogeneic NK cell transfer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse effects and Safety
Time Frame: 3 months
|
Adverse effects monitoring during and after vaccination
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NK transfer Immunogenicity
Time Frame: 6 months
|
Measure of NK response against SARS-Cov2 virus
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UNAL FSA COVID
- Estudio Clinico (Other Identifier: Fundación Salud de los Andes-Universidad Nacional)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 COVID
-
European Institute of OncologyFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta; Azienda Ospedaliera... and other collaboratorsCompleted
-
Owlstone LtdCambridge University Hospitals NHS Foundation TrustCompleted
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Sultan Qaboos UniversityCompletedCOVID-19 | Non-CovidOman
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Assiut UniversityRecruiting
-
Jilin UniversityUnknown
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Miami VA Healthcare SystemNot yet recruiting
Clinical Trials on Allogeneic NK transfer
-
Seoul National University HospitalGC Biopharma CorpCompletedSolid Tumors | Malignant LymphomasKorea, Republic of
-
National Institute of Allergy and Infectious Diseases...Completed
-
Beijing Kejing Biotechnology Co., Ltd.Beijing Kejing Biotechnology Corp.WithdrawnSolid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer)China
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingRecurrent Gliosarcoma | Recurrent Supratentorial Glioblastoma | Supratentorial GliosarcomaUnited States
-
Beijing 302 HospitalShenzhen Third People's Hospital; The first People's Hospital of ZhengzhouRecruitingHepatocellular CarcinomaChina
-
Fate TherapeuticsTerminatedMelanoma | Lymphoma | Renal Cell Carcinoma | Cervical Cancer | Head and Neck Cancer | Hepatocellular Carcinoma | Gastric Cancer | Colorectal Cancer | NSCLC | Advanced Solid Tumor | Small-cell Lung Cancer | HER2-positive Breast Cancer | Pancreas Cancer | Urothelial Carcinoma | Merkel Cell Carcinoma | Microsatellite Instability and other conditionsUnited States
-
Shanghai iCELL Biotechnology Co., Ltd, Shanghai...Hebei Yanda Ludaopei HospitalUnknownAcute Myeloid LeukemiaChina
-
The Second Hospital of Shandong UniversityNot yet recruiting
-
The Second Hospital of Shandong UniversityNot yet recruiting
-
GI Cell, Inc.RecruitingAdvanced Solid Tumors | Relapsed/Refractory Multiple Myeloma | Relapsed/Refractory Non-Hodgkin LymphomaKorea, Republic of