Viral Specific T Cell Therapy for COVID-19 Related Pneumonia

Early Phase 1

Completed

• Conditions: Malignant Solid Neoplasm; Symptomatic COVID-19 Infection Laboratory-Confirmed; Hematopoietic and Lymphoid Cell Neoplasm
• Interventions: Biological: SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes

• Registration Number: NCT04742595
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific T cell lines generated by ex vivo expansion as therapy of COVID19 pneumonia in cancer patients.

SECONDARY OBJECTIVES:

I. To obtain preliminary data about the efficacy of administering most closely HLA-matched SARS-COV-2 specific T cell lines generated by ex vivo expansion.

II. To assess the persistence of the administered cells in the patients.

OUTLINE:

Patients receive SARS-COV-2 specific cytotoxic T lymphocytes intravenously (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.

After completion of study treatment, patients are followed up at 7, 14, 21, 28, and 45 days, and 3 months after each cytotoxic T lymphocyte infusion.

Study Timeline

• Study Start: 2020-12-18
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-08
• Primary Completion: 2024-09-20
• Study Completion: 2024-09-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (SARS-COV-2 specific cytotoxic T cells)	SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes	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.

Primary Outcome Measures

Name	Time	Method
Assessment of feasibility	Up to 3 months post-infusion	Proportion of patients who receive at least one severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific cytotoxic T lymphocytes (CTLs) infusion. Study approach will be considered feasible if at least 50% of the enrolled eligible patients receive one CTLs infusion.
Incidence of adverse events	Up to 3 months post-infusion	Will collect adverse events and grade them according to Common Terminology Criteria for Adverse Events version 4.0. Attribution will be assigned based on the relationship to the cell infusion.

Secondary Outcome Measures

Name	Time	Method
Relapse free survival (original malignancy)	From treatment start date to the date of documented disease recurrence or death, assessed up to 3 months post-infusion	Will be estimated using the Kaplan-Meier method.
Cumulative incidence of coronavirus disease 2019 pneumonia resolution after therapy	Up to 3 months post-infusion
Reconstitution of anti-virus immunity	Up to 3 months post-infusion	Number of SARS-COV-2 specific T-cells in blood will be determined for each patient.
Proportion of subjects alive and free of respiratory failure	At 28 days post-infusion
Overall survival	From treatment start date to date of death, assessed up to 3 months post-infusion	Will be estimated using the Kaplan-Meier method.
All-cause mortality	At 28 days post-infusion
Cumulative incidence of grade 2-4 or 3-4 graft versus host disease (GVHD), and chronic GVHD	Up to 3 months post-infusion	Will be assessed using the competing risks method. The competing risks will include relapse and death and patients who are still alive without disease progression at end of study will be censored.
Response to cytotoxic T lymphocytes	Up to 2 weeks post-infusion	Defined as extubation for patients who required intubation and mechanical ventilation, reduction in the need of oxygen of 50% or a reduction in the fraction of inspired oxygen (FiO2) below 30% or oxygen discontinuation for patients who are not intubated but require oxygen, or resolution of clinical and radiological signs and symptoms for patients who do not require oxygen. Proportion of patients experiencing response will be computed with associated 95% confidence interval.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States