Viral Specific T Cell Therapy for COVID-19 Related Pneumonia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04742595|
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : August 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Symptomatic COVID-19 Infection Laboratory-Confirmed||Biological: SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes||Early Phase 1|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Administration of Expanded, Most Closely HLA Matched SARS-CoV-2-Specific T Cells for the Treatment of COVID-19 in Patients With Cancer|
|Actual Study Start Date :||December 18, 2020|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: Treatment (SARS-COV-2 specific cytotoxic T cells)
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
- Assessment of feasibility [ Time Frame: 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 [ Time Frame: 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.
- Response to cytotoxic T lymphocytes [ Time Frame: 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.
- Overall survival [ Time Frame: From treatment start date to date of death, assessed up to 3 months post-infusion ]Will be estimated using the Kaplan-Meier method.
- Relapse free survival (original malignancy) [ Time Frame: 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 [ Time Frame: Up to 3 months post-infusion ]
- Cumulative incidence of grade 2-4 or 3-4 graft versus host disease (GVHD), and chronic GVHD [ Time Frame: 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.
- All-cause mortality [ Time Frame: At 28 days post-infusion ]
- Proportion of subjects alive and free of respiratory failure [ Time Frame: At 28 days post-infusion ]
- Reconstitution of anti-virus immunity [ Time Frame: Up to 3 months post-infusion ]Number of SARS-COV-2 specific T-cells in blood will be determined for each patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742595
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Katy Rezvani, MD,PHD 713-794-4260 email@example.com|
|Principal Investigator: Katy Rezvani, MD,PHD|
|Principal Investigator:||Katy Rezvani||M.D. Anderson Cancer Center|