Anti-SARS Cov-2 T Cell Infusions for COVID 19

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 with COVID19 who are at high risk of requiring mechanical ventilation.

The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria.

Conditions

• SARS-CoV 2
• Viral Infection
• COVID 19

Interventions

BIOLOGICAL

Dose Finding Phase (MTD)

Enrollment to the dose escalation phase will be staggered. The first patient enrolled on each of the 3 dose levels (DL1, DL2 and DL3) will have to complete the 14-day toxicity monitoring window prior to enrollment of the next patients. Prior to dose escalation, all patients at a particular dose level should have completed the minimum 14-day toxicity monitoring window before enrolling to a higher dose level.

BIOLOGICAL

Partially HLA-matched SARS-CoVSTs

Infusion of SARS-CoVSTs at the MTD level as determined in the Dose Finding Phase

OTHER

Routine care (no SARS-CoVSTs)

Patients receive routine care for COVID19 per institutional standards (including antivirals such as remdesivir or other FDA-EUA approved products and thromboprophylaxis).

Sponsors & Collaborators

• Center for Cell and Gene Therapy, Baylor College of Medicine

  collaborator OTHER

• AlloVir

  collaborator INDUSTRY

• The Methodist Hospital Research Institute

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Premal Lulla · Baylor College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-04

Primary Completion

2021-10-12

Completion

2021-10-12

FDA Drug

Yes

Countries

• United States

Study Locations