AzTrials
AzTrials

COVID-19 Respiratory InfectionPhase 1/2NCT04990557

CRISPR/Cas9-modified Human T Cell ( PD-1and ACE2 Knockout Engineered T Cells ) for Inducing Long-term Immunity in COVID-19 Patients

A Phase 1/2 study testing PD-1 and ACE2 Knockout T Cells in people with COVID-19 Respiratory Infection, run by Mahmoud Ramadan mohamed Elkazzaz.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

T-cell exhaustion may limit long-term immunity in COVID-19 patients. T cells can lose their ability to fight viruses and tumors when they have prolonged exposure to these enemies. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
COVID-19 Respiratory Infection
What is being tested?
PD-1 and ACE2 Knockout T Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
No sites listed yet
Study dates
Aug 2021to Nov 2022
Phase
Phase 1/2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who recently recovered from mild COVID-19 disease (First, second and third infection).
  • Major organs function normally.
  • Women at pregnant ages should be under contraception..
  • Willing and able to provide informed consent

Who cannot join

  • Blood-borne infectious disease, e.g. hepatitis B.:
  • History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician.
  • With other immune diseases, or chronic use of immunosuppressants or steroids.
  • Compliance cannot be expected.
  • Other conditions requiring exclusion deemed by physician

Trial locations and contacts

No sites are listed yet.

Mahmoud R Elkazzaz, M.Sc of Biochemistry contact

+201090302015

mahmoudramadan2051@yahoo.com

About this study

T-cell exhaustion may limit long-term immunity in COVID-19 patients. T cells can lose their ability to fight viruses and tumors when they have prolonged exposure to these enemies. New data suggests people who experience mild COVID-19 symptoms show the molecular signs of exhausted memory T cells and therefore could have a reduced ability to fight reinfection. On contrary people who develop severe COVID-19 symptoms may be better protected from reinfection. A recent study reported that the 82.1% of COVID-19 cases displayed low circulating lymphocyte counts . It has been reported that, in the case of chronic viruses, continuous PD-1 expression causes T-cell exhaustion, and impairs the ability of killing the infectious cells . The adumbration of patients with COVID-19 is characterized by a diminished lymphocyte percentage, with a similar proportion of CD4+ and CD8+ T-cells. The quantity of T-cells, mostly CD8+ T-cells, presenting high expression rates of late activity marker CD25 and exhaustion marker PD-1 increases. Therefore, SARS-CoV-2 is able to make changes by modifying the acquired immune system, including B and T cells. According to experiments, PD-1's expression, as an important factor in the induction and maintenance of circumferential tolerance keeping the stability of T-cells, has been found to have a higher percentage in different cells of COVID-19 patients. In an experiment conducted by Diao et al., on the patients with SARS-CoV-2, it was observed that the expression of PD-1 on the surface of T-cells was increased significantly; it was also shown that during the SARS-CoV-2 -induced disease, additional expressions of PD-1 and Tim-3 on the T-cells were directly related to the disease's severity; the factors that were also increased in other viral infections. T cell exhaustion" phenomenon could be reversed relatively easily, for example when the T cells are no longer exposed to the virus or tumor. But unfortunately, although exhausted T cells recovered from chronic infection (REC-TEX) regain some function and features of memory T cells (TMEM), they retain epigenetic scars indicating the control of gene expression is "locked in" to their exhaustion history. Once T cells become exhausted, they remain fundamentally 'wired' to be exhausted-thus it may be hard to get them to become effective virus- and cancer-fighters again," said John Wherry, PhD, chair of the department of Systems Pharmacology and Translational Therapeutics and director of the Penn Institute of Immunology in the Perelman School of Medicine at the University of Pennsylvania. Furthermore, COVID-19 may infect T lymphocyte cells and induce apoptosis and apoptotic markers. Lymphocytopenia was also found in the Middle East respiratory syndrome (MERS) cases. MERS-CoV can directly infect human primary T lymphocytes and induce T-cell apoptosis through extrinsic and intrinsic apoptosis pathways, but it cannot replicate in T lymphocytes. However, it is unclear whether SARS-CoV-2 can also infect T cells, resulting in lymphocytopenia. A study showed that T cells express a very low expression level of hACE2 on its cell surface and T-cell lines were significantly more sensitive to SARS-CoV-2 infection when compared with SARS-CoV . In other words, these results tell us that T lymphocytes may be more permissive to SARS-CoV-2 infection. Therefore, it is plausible that the S protein of SARS-CoV-2 might mediate potent infectivity, even on cells expressing low hACE2, which would, in turn, explain why the transmission rate of SARS-CoV-2 is so high. Through recent advances in genomic editing, T cells can now be successfully modified via CRISPR/Cas9 technology. For instance, engaging (post-)transcriptional mechanisms to enhance T cell cytokine production, the retargeting of T cell antigen specificity or rendering T cells refractive to inhibitory receptor signaling can augment T cell effector function. Therefore, CRISPR/Cas9-mediated genome editing might provide novel strategies for inducing long term immunity against COVID-19.Immunotherapies with autologous T cells have become a powerful treatment option for many diseases like viral infection or cancer. These include the adoptive isolation and transfer of naturally-occurring virus/tumor-specific T cells and the transfer of T lymphocytes that have been genetically modified . According to the investigator, exhausted virus-reactive CD8+ memory T cells will be isolated from patients with mild infection using a modified antigen-reactive T cell enrichment (ARTE) assay. exhausted virus-reactive CD8+ memory T cells will be collected and both Programmed cell death protein 1(PDCD1) gene and ACE2 gene will be knocked out by CRISPR Cas9 in the laboratory. The lymphocytes will be selected and expanded ex vivo and infused back into patients.

Read the detailed description

This study will assess the safety of PD-1 and ACE2 knockout engineered T cells as genetically modified memory T cells capable of providing long-term immunity against COVID-19 by remembering and killing the virus if it is reintroduced. Blood samples will also be collected for research purposes. This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1 and ACE2 knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Biomarkers and immunological markers are collected and analyzed as well. According to the investigator, exhausted virus-reactive CD8+ memory T cells will be isolated from patients with mild infection using a modified antigen-reactive T cell enrichment (ARTE) assay. exhausted virus-reactive CD8+ memory T cells will be collected and Programmed cell death protein 1(PDCD1) gene and ACE2 gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 and ACE2 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. A total of 2 x 10^7/kg PD-1 and ACE2 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.

Being tested
PD-1 and ACE2 Knockout T Cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PD-1 and ACE2 Knockout T CellsDrug

    Autologous lymphocytes are collected and both PDCD1 and ACE2 gene knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment

  • PD-1 and ACE2 Knockout T CellsDrug

    Autologous lymphocytes are collected and both PDCD1 and ACE2 gene knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment

  • PD-1 and ACE2 Knockout T CellsDrug

    Autologous lymphocytes are collected and both PDCD1 and ACE2 gene knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment

Study groups in NCT04990557
Study groupRoleWhat they receive
A - Two cyclesExperimentalPeripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) and ACE2 gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1/ACE2 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. A total of 1 x 10^7/kg PD-1and ACE2 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.
Receives: Drug: PD-1 and ACE2 Knockout T Cells
B- Two cyclesExperimentalPeripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) and ACE2 gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1/ACE2 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. A total of 1 x 10^7/kg PD-1 and ACE2 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment. A total of 2 x 10^7/kg PD-1and ACE2 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.
Receives: Drug: PD-1 and ACE2 Knockout T Cells
C- Two cyclesExperimentalPeripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) and ACE2 gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1/ACE2 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. A total of 4 x 10^7/kg PD-1 and ACE2 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.
Receives: Drug: PD-1 and ACE2 Knockout T Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients

    Measured: Dose Escalation - Approximately 5 months

Secondary outcomes (6)
  1. Number of Patients With Overall Response to the reinfection

    Measured: 10 months

  2. All cause mortality rate

    The time from the date of first edited T cell infusion to the date of reinfection with COVID-19 or death due to any reason.

    Measured: Measured from Day 0 through Day 180

  3. Proportion of patients with upregulated inflammatory factors

    Upregulated inflammatory factors will be measured at different timepoint

    Measured: 1 month and 3 month

  4. Serum levels of IL-6,TNF,TLR3,CRP, ESR and Type I interferon

    Serum levels of IL-6,TNF,TLR3,CRP, ESR and Type I interferon will be measured at different timepoint

    Measured: 1 month and 3 month

  5. Absolute lymphocyte counts (CD4,CD8 and CD25+FOXP3+ Regulatory T)

    Absolute lymphocyte counts (CD4,CD8 and CD25+FOXP3+ Regulatory T) will be measured at different timepoint

    Measured: 1 month and 3 month

  6. Safety-Hematology

    white blood cells (WBC) Differential cell counts should be performed at baseline, at each visit during PD-1 Knockout Engineered T Cells infusion phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing.

    Measured: Measured from Day 0 through Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2021
  2. Study startAug 2021 (estimated)
  3. Primary completionNov 2022 (estimated)
  4. Study completionNov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04990557
Sponsor's protocol ID
Novel Treatment for Covid-19
Status last verified
Aug 2021
First submitted
1 Aug 2021
Last updated
16 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PD-1 and ACE2 Knockout T Cells in people with COVID-19 Respiratory Infection, run by Mahmoud Ramadan mohamed Elkazzaz.

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 4 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: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mahmoud R Elkazzaz, M.Sc of Biochemistry (+201090302015, mahmoudramadan2051@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients (time frame: Dose Escalation - Approximately 5 months). 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 16 Aug 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in