Frequently Asked Questions
What is CAR-T cell therapy?
CAR-T cell therapy is a new type of immunotherapy that uses reprogrammed T cells — a part of the immune system – to fight cancer. T cells are collected from the patient’s (autologous) or donor’s (allogeneic) blood, and then altered to generate CAR-T cells which has special structures on their surface called chimeric antigen receptors (CARs) that now enable the T cells to recognize proteins on tumor cells. These CAR-T cells are then multiplied artificially and infused back into the patient. These cells can now specifically target the tumor cells and kill them.
Why is CAR-T cell therapy so exciting?
With this therapy, the patient’s own immune cells have been modified to recognize and attack their cancer. CAR-T cell therapy provides a chance for durable remission in certain cancers where patients have very limited options of treatment. CAR-T cells are also referred to as ‘living drugs’ as they are cells that stay on in the patient’s body and maintain surveillance and kill any new tumor cells. This property enables long term response.
What types of cancer can be treated by CAR-T cell therapy?
Autologous CAR-T cell therapy is approved in some countries for haematological malignancies (Lymphoma and Leukemia) for patients who have not responded or refractory to standard lines of treatment. There are many cell and gene therapies in development for use in hematological and solid (organ) tumors. At this time, CAR-T cell therapy has been successful in demonstrating effectiveness for blood derived cancers. Research and clinical trials are underway to test CAR-T cell therapy formats for other tumors.
At this time, no cell and gene therapies for cancer are commercially available in India. Clinical trials evaluating cell and gene therapies in cancer patients are ongoing.
Why is CAR-T cell therapy called precision and personalised medicine?
Cancer cells proliferate in an uncontrolled manner. The treatment modalities such as chemotherapy or radiation targets proliferating cells non-specifically. Immunotherapy approaches including CAR-T cell therapy target very specific receptor(s) on the cancer cells which usually are not expressed by normal tissue types. This targeting is very precise. Also, since a person’s own immune cells are used to treat their cancer, this therapy is very personalised to each patient.
What are the possible side effects of CAR-T cell therapy?
CAR-T cell therapy may be associated with toxicities such as cytokine release syndrome (CRS) and neurotoxicity. These side effects are sometimes due to an exaggerated effect or response. Over the past few years, due to better understanding of how these treatments work, the management of these toxicities has also improved. Since these side effects are sometimes fatal, CAR-T cell therapies must always be delivered by a trained medical professional, and at a hospital where these side effects, if they occur, can be managed early and under medical guidance.
Why is CAR-T cell therapy so expensive?
Autologous CAR-T cell therapy is a personalised precision medicine customised for each patient. As an innovative therapy, the cost covers the research and clinical development that goes into bringing these state-of-the art medicines to market. With the current autologous approach, the ‘drug’ has to be made individually for every patient unlike other medicines that can be manufactured in bulk. The manufacturing process, technology and critical reagents in selecting and growing cells, apart from highly skilled scientists, extensive quality control and extended hospital stay to ensure care during and immediately following infusion – all contribute to the high costs associated with CAR-T cell therapy.
Ongoing studies are now focusing on how this autologous therapy can be made allogeneic in nature where-in several patients potentially could be treated using cells from a single donor.
Immuneel aspires to be the first to commercialise CAR-T cell therapy in India. It is also striving hard to make these therapies more ‘accessible’ and ‘affordable’ than current global costs. It is working to indigenous several processes with in-house development with an emphasis on ‘Make-in-India’ which will eventually lead to better access.
What is the future for CAR-T cell therapy?
CAR-T cell therapy has been approved in some countries for relapsed or refractory leukemia and lymphoma since 2017 and have resulted in significant improvements in cancer remission. However, this is currently very expensive. There are multiple clinical trials currently ongoing in different parts of the world recruiting patients for haematological (liquid) and solid (organ) tumors, although no trials are active in India. Although these treatments are being used in a relapsed or refractory patient at present, many experts believe their use earlier in therapy may be more beneficial, but this needs to be confirmed in clinical trials. Additionally, global research effort is underway to make these therapies safer and more effective for patients, as well as evaluating ways in converting the personalized autologous therapy into a more efficient allogeneic kind of therapy.
Where is CAR T-cell therapy available in India?
Currently, India does not have any approved CAR-T cell therapy. Clinical trials evaluating CAR-T cell therapy for cancer are ongoing. Once deemed successful and only after approval by the Regulatory Agency in India, can such therapies be made available at treatment centres/hospitals with specialized expertise in cell therapy.
