Clinical trial · Observational
SARS-CoV-2 Donor-Recipient Immunity Transfer
Observational Study of SARS-CoV-2 Donor-Recipient Immunity Transfer
NCT04666025CI-TRIAL-00075811completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study investigates whether donors with previous exposure to COVID-19 can pass their immunity by hematopoietic (blood) stem cell transplant (HCT) donation to patients that have not been exposed. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes the COVID19 infection. This study may provide critical information for medical decision-making and possible immunotherapy interventions in immunocompromised transplant recipients, who are at high risk for COVID19 severe illness.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase CML, BCR-ABL1 Positive | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Phase CML, BCR-ABL1 Positive | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
| COVID-19 Infection | — | UNRESOLVED | — |
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Diagnostic Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (biospecimen collection, medical chart review)
- description
- DONORS: Prior to HCT, sibling donors (MRD and haplo) undergo a nasopharyngeal swab per standard of care for SARS-Cov-2 testing. For MUD donors, initial testing may consist of a questionnaire. All donors undergo collection of blood and saliva at the time of granulocyte-colony stimulating factor (G-CSF). Donors' medical charts are also reviewed. RECIPIENTS: Patients undergo a nasopharyngeal swab for SARS-Cov-2 testing at 30, 60, 90, 120 days post-HCT, and afterwards as deemed necessary by the treating physician. Patients also undergo the collection of blood and saliva specimens at days 30, 60, 90, 120, 150, and 180 post-HCT. Recipients' medical charts are also reviewed.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Diagnostic Laboratory Biomarker Analysis
- Other: Electronic Health Record Review
- Other: Questionnaire Administration
Primary outcomes (3)
- measure
- Severe acute respiratory syndrome (SARS)-Coronavirus 2 (CoV-2) Spike protein (S)-specific IgG concentration and T cell levels
- timeFrame
- Up to 180 days post-hematopoietic stem cell transplant (HCT)
- description
- Testing for SARS-CoV-2 antibodies will be performed on serum samples using in house developed enzyme-linked immunosorbent assay (ELISA). The qualitative assays will be developed to investigate Spike subunit 1 (S1)-specific antibodies of the IgG, IgM and IgA subclasses in serum and saliva samples. All SARS-Cov-2 seropositive donor-HCT recipient pairs patients will undergo cellular immunogenicity evaluations using flow cytometry. The data analysis for estimating the effect of donor immunity transfer on functional cellular immunity through time will be exploratory in nature and will focus on graphical display and summary statistics. Longitudinal levels of T cells specific for SARS-CoV-2 S will be measured as a correlate of immunity transfer efficiency.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ALL COHORTS: Documented written informed consent of the participant * ALL COHORTS: Recipients must have a planned allogeneic HCT procedure. MRD, MUD, and haplo HCT allowed. Usage of post-transplant cyclophosphamide (PTCy) permitted only in haplo setting * ALL COHORTS: GCSF-mobilized peripheral blood stem cell (PBSC) only as graft source * ALL COHORTS: Planned HCT with minimal to no-T cell depletion of graft for the treatment of the following hematologic malignancies: * Lymphoma (Hodgkin and non-Hodgkin) * Myelodysplastic syndrome * Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography \[CT\] or CT/positron emission tomography \[PET\] scan without progression is allowed) * Acute myeloid leukemia in first or second remission * Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase * Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis * ALL COHORTS: Willingness to * Provide blood samples and saliva specimens * Permit medical record review * ADDITIONAL CRITERIA FOR RECIPIENTS IN THE MAIN COHORT: * Absence of documented COVID-19 history and active COVID-19 infection * ADDITIONAL CRITERIA FOR RECIPIENTS IN THE REFERENCE COHORT: Active COVID-19 infection during HCT
References
Publications (2)
- DERIVEDLa Rosa C, Chiuppesi F, Park Y, Zhou Q, Yang D, Gendzekhadze K, Ly M, Li J, Kaltcheva T, Ortega Francisco S, Gutierrez MA, Ali H, Otoukesh S, Amanam I, Salhotra A, Pullarkat VA, Aldoss I, Rosenzweig M, Aribi AM, Stein AS, Marcucci G, Dadwal SS, Nakamura R, Forman SJ, Al Malki MM, Diamond DJ. Functional SARS-CoV-2-specific T cells of donor origin in allogeneic stem cell transplant recipients of a T-cell-replete infusion: A prospective observational study. Front Immunol. 2023 Mar 3;14:1114131. doi: 10.3389/fimmu.2023.1114131. eCollection 2023. PMID 36936918
- DERIVEDLa Rosa C, Chiuppesi F, Park Y, Gendzekhadze K, Zhou Q, Faircloth K, Kaltcheva T, Johnson D, Ortega Francisco S, Amanam I, Otoukesh S, Pullarkat VA, Nakamura R, Diamond DJ, Forman SJ, Al Malki MM. Adoptive transfer of functional SARS-COV-2-specific immunity from donor graft to hematopoietic stem cell transplant recipients. Am J Hematol. 2022 Nov;97(11):E404-E407. doi: 10.1002/ajh.26691. Epub 2022 Sep 2. No abstract available. PMID 36053823