Status:
TERMINATED
Anti-SARS Cov-2 T Cell Infusions for COVID 19
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
AlloVir
Conditions:
SARS-CoV 2
Viral Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients wit...
Detailed Description
The first part of this study is to identify the maximum tolerated dose (MTD) of allogeneic SARS-CoV2-specific T cells (SARS-CoVSTs) for patients with COVID19 with high risk of progression to mechanica...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- SARS-CoV-2 infection confirmed by polymerase chain reaction assay (PCR) from a nasopharyngeal swab or other accepted specimen type. (If testing was performed ≥ 5 days before enrollment, this must be repeated and accept only if positive again). Date of COVID test must be ≤ 5 days prior to infusion.
- Currently hospitalized adult patient (≥ 18 years of age) requiring medical care for COVID19
- Peripheral oxygen saturation (SpO2) ≥ 92% on room air
- Hgb ≥ 7.0 gm/dl
- Negative pregnancy test (if applicable)
- Patient or parent/guardian capable of providing informed consent (may be obtained electronically)
- Evidence of pulmonary infiltrates on chest imaging. Any chest imaging findings which would be consistent with COVID19 would qualify (Eg: ground glass opacities, multifocal infiltrates etc.)
- High risk of requiring mechanical ventilation as defined by at least two of the following:
- Age ≥ 60 years of age
- Age ≥ 75 years of age (counts as meeting two criteria)
- Hypertension (HTN)
- Chronic cardiovascular disease other than HTN (eg: Coronary artery disease, congestive heart failure or cardiomyopathies).
- Diabetes Mellitus
- Obesity (BMI ≥ 30)
- Obesity (BMI ≥ 40, counts as meeting two criteria)
- Active cancer diagnosis or ongoing (within 3 months) cytotoxic chemo/ radio-therapy for a cancer
- Post-hematopoeitic stem cell or solid organ transplantation status
- Immunodeficiency states including HIV infection on antiretroviral therapy (except those listed as exclusion criteria #1, #7 and #10) as determined by the treating physician (eg: receiving immunosuppressive therapy like rituximab or congenital immunodeficiency syndromes, prior treatment with chemotherapy greater than 3 months ago but per investigators discretion could have lingering effects on the immune system, eg: chemotherapy regimens for lymphomas, ALL or AML etc.)
- Chronic obstructive pulmonary disease (COPD)
- Current everyday smoker
- Chronic kidney disease (eGFR \< 30 mL/min/1.73 m2 )
- Bronchial asthma (on active treatment prior to admission, eg. Use of rescue inhalers or inhaled corticosteroids or other treatments to prevent/treat attacks).
- Exclusion Criteria
- Received Anti-thymocyte globulin (ATG), Campath or other T cell immunosuppressive monoclonal antibodies in the 28 days prior to screening for enrollment
- Requiring mechanical ventilation at time of T cell infusion
- Alanine aminotransferase or aspartate aminotransferase greater than 5 x upper limit of normal
- If previously undergone an allogeneic hematopoietic stem cell transplant and have evidence of active acute GVHD greater than or equal to grade 2
- Uncontrolled relapse of malignancy
- Requiring vasopressors
- Known history of autoimmune disease except prior thyroiditis
- Is not suitable at the discretion of the treating physician
- Patients on greater than 6mg/day of dexamethasone (IV) or equivalent
- Greater than grade 1 CRS per American Society for Transplantation and Cellular Therapy (ASTCT) criteria
- Patients should not be enrolled on any other interventional clinical trials for COVID19. Patients may receive routine care for COVID19 per institutional standards (including antivirals such as remdesivir or other FDA-EUA approved products and thromboprophylaxis).
Exclusion
Key Trial Info
Start Date :
November 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04401410
Start Date
November 4 2020
End Date
October 12 2021
Last Update
December 19 2022
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030