Current situation
In 2018, the CRIS Cancer Foundation funded the construction of the CRIS Unit on the 8th floor of the Maternity Wing at the Hospital Universitario de la Paz. Coordinated by Antonio Pérez Martinez, this unit is forging ahead in the treatment of childhood cancers through clinical trials and advanced therapies. The interdisciplinary working structure funded by CRIS includes medical professionals, researchers, nurses, geneticists, immunologists, bioinformaticians, quality managers and data managers, etc.
Thanks to these state-of-the-art research facilities and the combined experience of the team led by Dr. Antonio Pérez, today the Unit is launching two cellular therapy clinical trials as a result of the health emergency to find effective therapies against COVID19.
One of the therapeutic options involves not so much attacking the virus itself but providing the body with tools to fight it. these possibilities include cellular therapies, which consist of infusing cell reinforcements from the immune system into patients with severe symptoms.
The situation is as follows: When a patient is infected, their body will activate certain immune system cells called T lymphocytes that effectively fight the infected cells. The majority of infected people are able to reject the infection at this stage; however, some patients do not succeed and develop severe symptoms. In most of these patients, lymphocyte numbers are alarmingly low in number.
These lymphocytes specialise in eliminating the virus, so the receiving patient will have reinforcements of specialist cells to destroy the virus. An infusion of these lymphocytes in patients who are seriously ill with COVID19 can substantially improve their prognosis and condition, by providing the patient with specialised cellular reinforcements.
The aim of the project
This trial proposes to extract T lymphocytes (T cells of the immune system specialised in destroying infected cells) from patients who have recovered from the infection and infuse them into seriously ill patients. Patients who receive this therapy will recover much faster from the infection with minimal side effects.
This is a Phase I clinical trial to evaluate the safety, tolerability and efficacy of treating patients with specialised T cells against SARS-CoV-2. One important aspect is that these infusions of cells must be taken from compatible donors, otherwise the patient’s body will reject the therapy. Therefore, the widest possible variety of donors will be required to make sure there are suitable donors for 90% of the population.
In the first phase of the trial, this infusion shall be performed on a group of up to 9 patients, to evaluate the proper dosage and rule out possible toxicities.
In the second phase, the optimal dose will be used in 10 patients, although it could be extended.
It is important to note that a single donor can provide cells for several patients; this means that any unused cells will be stored in a repository, called a LINFOTECA, where they will be kept frozen for future patients suffering from a severe form of COVID-19.
The results will also be extremely relevant for the future, because if this trial works, it could demonstrate that therapy with T lymphocytes might be useful in any future pandemic when no specific treatments have been developed yet.
Budget
The total budget for carrying out the clinical trial at the Hospital Universitario La Paz in Spain is €489,100
This budget can be broken down as follows:
- Donor selection experiments with Cytostim, Rapid Cytokine inspector Peptivatorr kit (M, N, S): €5,500
- Apheresis Kits: €4,000
- HLA analysis: €600
- Monitoring of patients using flow cytometry: €2,000
- CliniMACS SARS-CoV-2 kits (18 patients): €203,000
- CliniMACS Prodigy: € 242,000
- Clinical Trials insurance and AEMPS expenses: € 10,000
- Publications: € 2,000
- Management and Monitoring: €20,000
- Total: € 489,100