Viral Specific T Cell Therapy for COVID-19 Related Pneumonia

NCT04742595 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 2020-0759NCI-2020-13875
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Symptomatic COVID-19 Infection Laboratory-Confirmed

Outcome Measures

Primary Outcomes (2)

• Assessment of feasibility

  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.

  Up to 3 months post-infusion

• Incidence of adverse events

  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.

  Up to 3 months post-infusion

Secondary Outcomes (8)

• Response to cytotoxic T lymphocytes

  Up to 2 weeks post-infusion

• Overall survival

  From treatment start date to date of death, assessed up to 3 months post-infusion

• 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

• Cumulative incidence of coronavirus disease 2019 pneumonia resolution after therapy

  Up to 3 months 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

Study Arms (1)

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

EXPERIMENTAL

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.

Biological: SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes

Interventions

SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes BIOLOGICAL

Given IV

Also known as: SARS-CoV-2 Antigen-specific CTLs, SARS-CoV-2 Antigen-specific Cytotoxic T Lymphocytes, SARS-CoV-2-specific Cytotoxic T-lymphocytes

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Immunocompromised patients with hematological malignances and diagnosis of COVID-19 \> 3 weeks prior to study entry, treated with at least one SOC therapy (i.e., remdesivir, monoclonal antibody \[bebtelovimab or newer one\], paxlovid, molnupiravir, corticosteroids, other EUA or FDA-approved therapies) with progression of symptoms in the following 14 days after treatment started, of at least 1 category on the 8 ordinal category on the 8 ordinal category WHO scale, or CT chest/CXR shows progression of pneumonia or increase oxygen requirements of at least 2 liters from baseline. Patients should not show signs of improvement before enrollment.
• World health organization (WHO) scale:
• Not hospitalized and no COVID-19 related symptoms;
• Not hospitalized, with COVID-19 related symptoms;
• Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedical reasons);
• Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to COVID-19);
• Hospitalized, requiring any supplemental oxygen by nasal cannula;
• Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices;
• Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and
• Death.
• Immunocompromised patient with hematological malignances is defined as:
• Recipients of an allogeneic stem cell transplantation or other form of cell therapy, for example CAR T-cell therapy
• Patients with hematological malignancies who have been in MRD-negative CR for less than 3 years from the completion of their last treatment.
• Patients with hematological malignancies who have been in MRD-negative CR for more than 3 years from the completion of their last therapy and have a peripheral blood CD4 count \<200x109cells/liter
• Patients with hematological malignances who are not in MRD-negative CR and are not expected to require anticancer treatment for at least 28 days after the CTLs infusion.

You may not qualify if:

• Patients receiving systemic steroids at time of enrollment (physiological substitutive therapy s allowed), or who have received ATG --within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
• Patients with other infections other than COVID-19
• Active acute or chronic GVHD.
• Patients receiving immunosuppressive therapy
• Patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• David Marin, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: December 18, 2020
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

US (1)