Hematopoietic and Lymphoid Cell NeoplasmEarly Phase 1NCT04742595
Viral Specific T Cell Therapy for COVID-19 Related Pneumonia
A Early Phase 1 study testing SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed
- What is being tested?
- SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 20 Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
- English and non-English speaking patients. 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed
- Being tested
- SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytesBiological
Also called SARS-CoV-2 Antigen-specific CTLs, SARS-CoV-2 Antigen-specific Cytotoxic T Lymphocytes, SARS-CoV-2-specific Cytotoxic T-lymphocytes
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 months post-infusion
Secondary outcomes (8)
Response to cytotoxic T lymphocytes
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.
Measured: Up to 2 weeks post-infusion
Overall survival
Will be estimated using the Kaplan-Meier method.
Measured: From treatment start date to date of death, assessed up to 3 months post-infusion
Relapse free survival (original malignancy)
Will be estimated using the Kaplan-Meier method.
Measured: 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
Measured: Up to 3 months post-infusion
Cumulative incidence of grade 2-4 or 3-4 graft versus host disease (GVHD), and chronic GVHD
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.
Measured: Up to 3 months post-infusion
All-cause mortality
Measured: At 28 days post-infusion
Proportion of subjects alive and free of respiratory failure
Measured: At 28 days post-infusion
Reconstitution of anti-virus immunity
Number of SARS-COV-2 specific T-cells in blood will be determined for each patient.
Measured: Up to 3 months post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start18 Dec 2020
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Marin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742595
- Sponsor's protocol ID
- 2020-0759
- Other IDs
- NCI-2020-13875, 2020-0759
- Status last verified
- Oct 2024
- First submitted
- 3 Feb 2021
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04742595
- Acronym / sponsor ID
- 2020-0759
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SARS-COV-2 specific cytotoxic T cells) | Experimental | Biological: SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytesAlso: SARS-CoV-2 Antigen-specific CTLs, SARS-CoV-2 Antigen-specific Cytotoxic T Lymphocytes, SARS-CoV-2-specific Cytotoxic T-lymphocytesGiven IV | Biological | Treatment (SARS-COV-2 specific cytotoxic T cells) |
Primary outcome
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.
8 secondary outcomes
Response to cytotoxic T lymphocytes
Time frame: Up to 2 weeks post-infusion
Overall survival
Time frame: From treatment start date to date of death, assessed up to 3 months post-infusion
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Marin, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of feasibility (time frame: Up to 3 months post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.