Status:
COMPLETED
Viral Specific T Cell Therapy for COVID-19 Related Pneumonia
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 a...
Detailed Description
PRIMARY OBJECTIVE: I. To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific T ...
Eligibility Criteria
Inclusion
- 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:
- Not hospitalized and no COVID-19 related symptoms;
- Not hospitalized, with COVID-19 related symptoms;
- Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedical reasons);
- Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to COVID-19);
- Hospitalized, requiring any supplemental oxygen by nasal cannula;
- Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices;
- Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and
- 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.
Exclusion
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04742595
Start Date
December 18 2020
End Date
September 20 2024
Last Update
October 29 2024
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030