Viral Specific T Cell Therapy for COVID-19 Related Pneumonia
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|ClinicalTrials.gov Identifier: NCT04742595|
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : May 3, 2023
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|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, 2024|
|Estimated Study Completion Date :||March 31, 2024|
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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients age 18 years or older with COVID-19 related infection, defined as patients with a positive SARS-CoV-2 positive reverse transcriptase polymerase chain reaction (RT-PCR) test (bronchoalveolar lavage [BAL], nasal or pharyngeal) within 2 weeks of enrollment and respiratory symptoms (e.g., cough, shortness of breath, chest pain, hemoptysis, nasal congestion, rhinorrhea, anosmia).
Immunocompromised patient with cancer defined as:
- Recipients of an stem cell transplantation
- Patients with hematological malignancies who have been in minimal residual disease (MRD)-negative complete remission (CR) for less than 3 years
- Patients with hematological malignances who have received chemotherapy, targeted therapy or immunotherapy within 6 months prior enrollment and who are not planned to receive additional therapy for at least 6 weeks after the infusion. All non-hematological toxicity from prior therapy must have been recovered to grade II or less prior enrollment
- Patients organ solid malignances who have received chemotherapy, targeted therapy or immunotherapy within 6 months prior enrollment and who are not planned to receive additional chemotherapy, targeted therapy or immunotherapy for at least 6 weeks after the infusion. All toxicity from prior therapy must have been recovered to grade II or less prior enrollment
- 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
- Patients with organ solid malignancies who received chemotherapy, targeted therapy or immunotherapy more than six months prior enrollment and have a peripheral blood CD4 count < 200 x 10^9cells/liter
- Written informed consent and/or signed assent from patient, parent or guardian
- Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study
- Willingness to comply with the study protocol requirements
- Patients receiving prednisone > 0.1 mg/kg/day or equivalent at time of enrollment, or who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment
- Patients with other uncontrolled infections other than COVID-19: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection
- Karnosky < 70 prior to SARS-COV-2 infection
- Active acute graft versus host disease (GVHD) grade >= 2
- Patients with primary lung cancer not in remission and patients with existing lung metastasis of solid organ tumors
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
|Contact: David Marin, MDemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: David Marin, MD 713-792-4179 firstname.lastname@example.org|
|Principal Investigator: Katy Rezvani, MD|
|Principal Investigator:||David Marin, MD||M.D. Anderson Cancer Center|
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
NCI-2020-13875 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0759 ( Other Identifier: M D Anderson Cancer Center )
|First Posted:||February 8, 2021 Key Record Dates|
|Last Update Posted:||May 3, 2023|
|Last Verified:||May 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases