SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes for Symptomatic COVID-19 Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Symptomatic COVID-19 Infection+2 MoreSARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if SARS-CoV-2 specific cytotoxic T lymphocytes (CTLs), a type of immune cell, can help control the COVID-19 in cancer patients.

Eligible Conditions
  • Symptomatic COVID-19 Infection
  • Cancer
  • Blood Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 3 months post-infusion

At 28 days post-infusion
All-cause mortality
Proportion of subjects alive and free of respiratory failure
Month 3
Overall survival
Month 3
Relapse free survival (original malignancy)
Week 2
Response to cytotoxic T lymphocytes
Month 3
Assessment of feasibility
Cumulative incidence of coronavirus disease 2019 pneumonia resolution after therapy
Cumulative incidence of grade 2-4 or 3-4 graft versus host disease (GVHD), and chronic GVHD
Incidence of adverse events
Reconstitution of anti-virus immunity

Trial Safety

Trial Design

1 Treatment Group

Treatment (SARS-COV-2 specific cytotoxic T cells)
1 of 1

Experimental Treatment

16 Total Participants · 1 Treatment Group

Primary Treatment: SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes · No Placebo Group · Phase < 1

Treatment (SARS-COV-2 specific cytotoxic T cells)
Biological
Experimental Group · 1 Intervention: SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 months post-infusion

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,518 Total Patients Enrolled
David Marin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
94 Total Patients Enrolled
Katy RezvaniPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
100 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are of childbearing potential and are willing to use an effective contraceptive measure while on study.
You have a solid malignancy and you have received chemotherapy, targeted therapy or immunotherapy within 6 months prior enrollment and you are not planned to receive additional chemotherapy, targeted therapy or immunotherapy for at least 6 weeks after the infusion.
Patients with hematological malignancies who have been in MRD-negative CR for more than 3 years and have a peripheral blood CD4 count < 200 x 10^9cells/liter.
You have a peripheral blood CD4 count of < 200 x 10^9 cells/liter.