Viral Specific T Cell Therapy for COVID-19

Recruiting in Palo Alto (17 mi)

Overseen byDavid Marin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Marin, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for cancer patients with weakened immune systems due to treatments or low CD4 counts, who have COVID-19. They must be in remission or not planning further cancer treatment soon and able to follow the study rules. Pregnant women can't join, and participants need a negative pregnancy test and agree to use contraception.

Inclusion Criteria

Written informed consent and/or signed assent from patient, parent or guardian

I've been cancer-free for over 3 years but have a low CD4 count.

I have received a stem cell transplant.

See 8 more

Exclusion Criteria

I have a severe reaction from a recent transplant.

I have an infection under control with no worsening signs for the required time before joining.

I am not currently taking high doses of prednisone, nor have I recently received specific immune treatments.

See 2 more

Treatment Details

Interventions

SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes (Virus Therapy)

Trial OverviewThe trial tests if special immune cells (CTLs) grown from donated blood can fight COVID-19 in these patients. It's an early-stage study looking at whether this approach is doable, beneficial, and what side effects it might have.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (SARS-COV-2 specific cytotoxic T cells)Experimental Treatment1 Intervention

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.