Clinical trial · Interventional
Viral Specific T Cell Therapy for COVID-19 Related Pneumonia
Administration of Expanded, Most Closely HLA Matched SARS-CoV-2-Specific T Cells for the Treatment of COVID-19 in Patients With Cancer
- 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 early phase I trial identifies the feasibility, possible benefits and/or side effects of administering SARS-CoV-2 specific cytotoxic T lymphocytes (CTLs) in treating cancer patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the virus responsible for coronavirus disease 2019 (COVID-19). SARS-CoV-2 Specific CTLs are a type of immune cells that are made from donated blood cells grown in the laboratory and are designed to kill cells infected with SARS-CoV-2 virus. Giving CTLs may help control the COVID-19 in cancer patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Symptomatic COVID-19 Infection Laboratory-Confirmed | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SARS-COV-2 specific cytotoxic T cells)
- description
- Patients receive SARS-COV-2 specific cytotoxic T lymphocytes IV over 30 minutes on day 1. Treatment may repeat every 14 days at investigators' discretion if patient fails to respond, the infection reoccurs, until the viral load becomes negative or until complete resolution of clinical and radiological signs.
- interventionNames
- Biological: SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes
Primary outcomes (2)
- measure
- Assessment of feasibility
- timeFrame
- Up to 3 months post-infusion
- description
- Proportion of patients who receive at least one severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific cytotoxic T lymphocytes (CTLs) infusion. Study approach will be considered feasible if at least 50% of the enrolled eligible patients receive one CTLs infusion.
- measure
- Incidence of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria:
Immunocompromised patients with hematological malignances and diagnosis of COVID-19 \> 3 weeks prior to study entry, treated with at least one SOC therapy (i.e., remdesivir, monoclonal antibody \[bebtelovimab or newer one\], paxlovid, molnupiravir, corticosteroids, other EUA or FDA-approved therapies) with progression of symptoms in the following 14 days after treatment started, of at least 1 category on the 8 ordinal category on the 8 ordinal category WHO scale, or CT chest/CXR shows progression of pneumonia or increase oxygen requirements of at least 2 liters from baseline. Patients should not show signs of improvement before enrollment.
* World health organization (WHO) scale:
1. Not hospitalized and no COVID-19 related symptoms;
2. Not hospitalized, with COVID-19 related symptoms;
3. Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedical reasons);
4. Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to COVID-19);
5. Hospitalized, requiring any supplemental oxygen by nasal cannula;
6. Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices;
7. Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and
8. Death.
Immunocompromised patient with hematological malignances is defined as:
* Recipients of an allogeneic stem cell transplantation or other form of cell therapy, for example CAR T-cell therapy
* Patients with hematological malignancies who have been in MRD-negative CR for less than 3 years from the completion of their last treatment.
* Patients with hematological malignancies who have been in MRD-negative CR for more than 3 years from the completion of their last therapy and have a peripheral blood CD4 count \<200x109cells/liter
* Patients with hematological malignances who are not in MRD-negative CR and are not expected to require anticancer treatment for at least 28 days after the CTLs infusion.
English and non-English speaking patients. Written informed consent and/or signed assent from patient, parent or guardian. Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
Willingness to comply with the study protocol requirements.
Exclusion criteria:
* Patients receiving systemic steroids at time of enrollment (physiological substitutive therapy s allowed), or who have received ATG --within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
* Patients with other infections other than COVID-19
* Active acute or chronic GVHD.
* Patients receiving immunosuppressive therapy
* Patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.References
Publications (0)
Data not yet available