SARS-CoV2-specific T cell lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. The cells are then frozen.These cells will be used to treat patients with confirmed SARS-CoV-2 infection who are at high risk of requiring mechanical ventilation.
Full Title of Study: “BAT IT: Banked Anti-SARS Cov-2 T Cell Infusions for Treatment of COVID 19″
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: August 15, 2021
Earlier, a healthy donor provided blood cells to generate donor SARS-CoV2-specific T cell product. These cells were grown and frozen for later use. Before being treated, the patient will receive a series of standard medical tests:
- Physical exam and history including height and weight
- SARS-CoV-2 test
- Blood tests
- Chest X-ray or chest CT Scan if not already done in the past 48 hours.
- A urine pregnancy test, when applicable
These tests are done to assess the patient's eligibility to receive the cells. On the day that the patient is scheduled to receive the cells they will be pre-medicated with Benadryl and Tylenol. If a match is identified from the bank, the SARS-CoV-2 T cells will be thawed and given to the patient through an intravenous line. All participants on this study will be infused with the same number (dose) of cells and monitored for infusion side effects for up to 14 days or until infusion side effects have completely resolved, whichever is longer. To learn more about the way the cells are working in the patient's body, up to an extra 30-40 ml (6-8 teaspoons) of blood may be taken before the infusion and then up to daily for 14 days or until the patient is discharged from the hospital. We also may collect samples from the patient at later timepoints (2 and 3 months after infusion) but these are optional.
- Biological: Partially HLA-matched Virus Specific T cells (VSTs)
- Patients will receive 4 x 10^7 partially HLA-matched Virus Specific T cells (VSTs) as a single infusion.
Arms, Groups and Cohorts
- Experimental: Treatment arm
- Partially HLA-matched Virus Specific T cells (VSTs) will be thawed and given by intravenous injection.
Clinical Trial Outcome Measures
- Safety of administering partially HLA-matched SARS-CoVSTs to hospitalized COVID19 patients with high risk of progression to mechanical ventilation.
- Time Frame: 14 days post infusion
- Primary end point: Treatment-related adverse events (tAE), including GVHD, worsening CRS, and any other treatment-related toxicities by day 14 post-infusion.
- Efficacy of anti-COVID19 of administering banked partially HLA-matched SARS-CoVSTs to hospitalized COVID19 patients.
- Time Frame: 14 days post infusion
- Secondary endpoint: Improvement on the WHO Ordinal Scale by day 14 post-infusion.
Participating in This Clinical Trial
1. SARS-CoV-2 infection confirmed by PCR from a nasopharyngeal swab or other accepted specimen type < 5 days before planned T cell infusion
2. Currently hospitalized adult patient (≥ 18 years of age) requiring medical care for COVID19, who provides informed consent (informed consent maybe obtained electronically)
3. Peripheral oxygen saturation (SpO2) ≥ 92% on room air
4. Hgb ≥ 7.0 gm/dl
5. Available SARS-CoV2- specific T lymphocyte line
6. Negative pregnancy test (if applicable)
7. Patient or parent/guardian capable of providing informed consent
8. Evidence of radiographic pulmonary infiltrates. Any chest radiographic findings which would be consistent with COVID19 would qualify (Eg: ground glass opacities, multifocal infiltrates etc.)
9. High risk of requiring mechanical ventilation as defined by at least two of the following:
1. Age ≥ 65 years of age
3. Chronic cardiovascular disease other than HTN that in the investigators opinion would worsen potential adverse effects of T cell therapy
4. Diabetes Mellitus
5. Obesity (BMI>35)
6. Active cancer diagnosis or ongoing (within 3 months) cytotoxic chemo/ radio-therapy for a cancer
7. Post-hematopoeitic stem cell or solid organ transplantation status
8. Immunodeficiency states as determined by the treating physician (eg: receiving immunosuppressive therapy like rituximab or congenital immunodeficiency syndromes, prior treatment with chemotherapy > 3 months ago but per investigators discretion could have lingering effects on the immune system, eg: chemotherapy regimens for lymphomas, ALL or AML etc.
1. Received ATG, Campath or other T cell immunosuppressive monoclonal antibodies in the 28 days prior to screening for enrollment
2. Requiring mechanical ventilation at time of T cell infusion
3. Alanine aminotransferase or aspartate aminotransferase > 5 x upper limit of normal
4. If previously undergone an allogeneic HSCT and have evidence of active acute GVHD > grade 2
5. Uncontrolled relapse of malignancy
6. Requiring vasopressors
7. Evidence of prior HIV infection
8. Known history of autoimmune disease except prior thyroiditis
9. Is not suitable at the discretion of the treating physician
10. Patients on ≥0.5mg/kg prednisone or equivalent
11. > grade 1 CRS per ASTCT criteria
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Baylor College of Medicine
- Center for Cell and Gene Therapy, Baylor College of Medicine
- Provider of Information About this Clinical Study
- Principal Investigator: Premal Lulla, Assistant Professor – Baylor College of Medicine
- Overall Official(s)
- Premal Lulla, Principal Investigator, Baylor College of Medicine
- Overall Contact(s)
- Premal Lulla, MD, 832-824-4847, firstname.lastname@example.org
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