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CAR-T therapy can be safely manufactured at hospital, finds ICMR-funded trial led by CMC Vellore
CAR-T therapy can be safely manufactured at hospital, finds ICMR-funded trial led by CMC Vellore

The Hindu

time22-05-2025

  • Health
  • The Hindu

CAR-T therapy can be safely manufactured at hospital, finds ICMR-funded trial led by CMC Vellore

An ICMR-funded trial led by CMC Vellore demonstrated that CAR-T therapy, which uses a patient's own T cells to fight cancer, can be safely manufactured at the hospital and infused to treat patients in India at a low cost. For the first time, these CAR-T cells were produced and infused in a hospital in India. CMC Vellore director and principal author of the study Vikram Mathews explained that Chimeric antigen receptor T cells (CAR-T cells) are normal T-cells that are part of the patient's own immune system. In CART-T cell therapy, these cells are engineered to recognise and target the specific cancer cell, thus using the immune system to fight the disease. CAR-T cell therapy has been proven to be very effective even in patients who have failed all other therapies, he said. This process usually involves inserting into the normal T cells, the required genetic information to produce an antibody receptor that will recognise the antigen/substance on the surface of the cancer cell. "This process is usually done in large centralised commercial corporations, which contributes to logistic challenges, increased costs, and decreased efficacy," Dr. Mathews said. One of many strategies to reduce the cost of this therapy, is to produce the CAR-T cells at the hospital site itself, this strategy is called decentralized or point-of-care manufacturing (PoC). In this study, the authors provided evidence that this is feasible in India. What did the study find? Early data from this study establishes its safety and also shows promising results, said Dr Mathews said. A total of 10 patients, aged 6-59 years, six of them with acute leukemia and four with lymphoma, who had failed all earlier treatments, were treated with CAR-T cells manufactured at CMC Vellore under this PoC strategy. The study found that the therapy brought about 100 per cent remission in acute lymphoblastic leukaemia patients, 50 per cent remission in large B-cell lymphoma patients. Overall, eight of the ten patients remained cancer-free at a median follow-up of 15 months since starting the therapy. The doctors further reported that this was safe, well-tolerated, and had minimal side effects. The study, 'Safety, efficacy and total cost of point-of-care manufactured anti-CD19 CAR-T cell therapy in India: VELCART trial' has been published in the journal Molecular Therapy. The study also stated that when CART-T cells are manufactured in this PoC model, the cost of the therapy is nearly 90 per cent less than the global average. The production time for the CART-T cells was nine days in in-hospital settings. Dr Mathews said that the use of a fresh, unfrozen product also contributed to better outcomes. "This trial redefines how cancer therapy can be delivered - efficiently, affordably, and close to patients. India is leading the way in developing next-generation, in-house biotherapies with global relevance," he said. "This model could be easily replicated in most tertiary healthcare facilities in the country," Dr Mathews said.

Cancer therapy gets cheaper and effective: CAR T-cells developed in hospital, patients in remission
Cancer therapy gets cheaper and effective: CAR T-cells developed in hospital, patients in remission

Indian Express

time22-05-2025

  • Health
  • Indian Express

Cancer therapy gets cheaper and effective: CAR T-cells developed in hospital, patients in remission

In a significant breakthrough, CAR T-cell therapy, which uses patients' T-cells to fight cancer by re-engineering them, was developed by and infused at the hospital where they were admitted. Normally, this is done in specialised centres, which pushes up cost and logistics. But with this method, the therapy becomes affordable, costing almost 90 per cent less than the global average. The phase 1 VELCART trial was conducted successfully at Christian Medical College(CMC), Vellore and was funded by the Indian Council of Medical Research (ICMR). 'It is the first trial in the country to do point-of-care development of T-cells in a hospital setting. Once produced, these can be infused to treat patients at a low cost,' says CMC Vellore director and principal study author Dr Vikram Mathews. What were the study findings? Altogether 10 patients, aged between 6 and 59, were selected after other treatments failed to improve their condition. Six of them had acute leukemia and four had lymphoma. They were treated with CAR T-cells developed at CMC Vellore over nine days as part of a point-of-care (PoC) strategy. The study found that the therapy brought about 100 per cent remission in acute lymphoblastic leukaemia patients and 50 per cent remission in large B-cell lymphoma patients. 'Overall, eight of the ten patients remained cancer-free at a median follow-up of 15 months. The therapy was safe, well-tolerated and had minimal side effects,' says Dr Mathews. If successful in Phase II trials across multiple centres, this model can be replicated in tertiary hospitals across the country. How was the therapy developed? Dr Mathews explains that chimeric antigen receptor T-cells (CAR T-cells) are normal T-cells that are part of the patient's own immune system. 'This process usually involves inserting the required genetic information into normal T-cells to produce an antibody receptor that will recognise the antigen/substance on the surface of the cancer cell. This is usually done in large centralised commercial corporations, which contributes to logistic challenges, increased costs, and decreased efficacy,' he says. But produced at the hospital site itself, this could be effective at a lower cost. 'Just imagine if 100 centres could manufacture CAR T-cells at the hospital. Wouldn't it significantly bring down cost in the long run?' he asked. Why is the trial significant? Access to CAR T-cell therapy is limited by cost and turnaround time, even in developed countries. The current centralized model with industry-driven CAR T- cell manufacturing is not viable to the requirements and realities of developing countries like India. Researchers, however, have provided evidence that this is feasible in India. 'The early data from this study establishes its safety and also shows promising results,' says Dr Mathews. Redefining cancer therapies Dr Mathews says researchers used fresh, unfrozen CAR T-cells, which resulted in better outcomes. Unfrozen CAR T-cells are infused directly into the patient after the modification and expansion process, bypassing the freezing step. This approach aims to preserve the cells' fresh, robust state, potentially leading to better anti-tumour activity. This also means that infusion can occur sooner after the cell modification process, potentially shortening the treatment timeline. 'Our trial redefines how cancer therapy can be delivered — efficiently, affordably and close to patients. India is leading the way in developing next-generation, in-house biotherapies with global relevance,' Dr Mathews says. The study, titled 'Safety, efficacy and total cost of point-of-care manufactured anti-CD19 CAR-T cell therapy in India: VELCART trial', has been published in the journal Molecular Therapy. Anuradha Mascarenhas is a journalist with The Indian Express and is based in Pune. A senior editor, Anuradha writes on health, research developments in the field of science and environment and takes keen interest in covering women's issues. With a career spanning over 25 years, Anuradha has also led teams and often coordinated the edition. ... Read More

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