Mumbai: Nearly 14 months after the clinical trials of the indigenously developed CAR-T technology for blood cancer treatment was kicked off at the Tata Memorial Centre (TMC), researchers have concluded the first phase of trials and called the results encouraging.
This is the first time that gene therapy indigenously developed by researchers at the Indian Institute of Technology (IIT), Bombay, was tested on patients in India.
Phase I clinical trial data demonstrates that Indias first indigenously developed novel CAR-T Cell therapy is safe and shows promising early sign of efficacy in treating Lymphoma, a type of blood cancer, said a statement released by IIT B, late on Sunday evening.
In June 2020, the central governments National Biopharma Mission (NBM) -Biotechnology Industry Research Assistance Council (BIRAC) had approved 18.96 crore to the team for conducting a first-in-human phase-I/II clinical trial of the CAR-T cells. The drug has the potential to benefit cancer patients, who currently are forced to opt for only palliative care.
While existing treatments work towards increasing the life of patients by a few years or months, CAR-T technology holds the promise of curing certain types of cancers. Unlike chemotherapy, this drug is administered only once to a patient.
Dr Gaurav Narula, principal investigator of the paediatric-Acute Lymphocytic Leukemia (ALL), TMC and Dr Hasmukh Jain, principal investigator of the adult B-cell lymphoma study, started recruiting patients in early 2021. So far, six patients in pediatric-ALL and 10 patients in adult lymphoma studies were treated with indigenous HCAR19.
The trials were conducted at the Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), the research and development wing of TMC.
The participants received autologous HCAR19 therapy. None of the participants had immune effector cell-associated neurotoxicity syndrome. Three out of ten participants had a complete response post CAR-T cell therapy and none of the participants required ICU admission. There was no CAR-T treatment related death. Overall, the novel humanized HCAR19 tested in Phase I clinical trials for adult lymphoma was found to be safe and has shown promising early signs of activity, said Dr Hasmukh Jain, who presented the data in the Annual Symposium of Cell and Gene Therapy, CMC Vellore.
Chimeric Antigen Receptor T (CAR-T) cells are genetically engineered to produce an artificial T-cell receptor, which is widely used in developed nations for immunotherapy during treatment for cancer. As part of gene therapy, these cells are used with an intent to cure certain types of blood cancers. However, the technology is still unavailable in India.
IIT Bombay and Tata Memorial Hospital (TMH) started their R&D collaboration in 2015 to develop the novel CAR-T cell therapy platform for cancers and immune-disorders. Dr Rahul Purwar, Associate Professor, IIT Bombay (on-lien) and currently appointed as CEO of ImmunoACT, designed and developed the indigenous CAR-T platform and patented anti-CD19 CAR-T product (HCAR19). In early 2021, HCAR19 product entered into two Phase 1 clinical trials at TMH, Mumbai.
Dr Gaurav Narula will present the results of Phase I trial of paediatric B-ALL in the Asia Pacific Blood and Marrow Transplantation (APBMT) 2022 meeting soon. The clinical trials will now enter Phase-II, post approvals from the Central Drug Standard Control Organisation (CDSCO) and is expected to be available for commercial clinical usage in 2024.
Points for graphic:
IIT Bombay and Tata Memorial Hospital (TMH) started their R&D collaboration in 2015 to develop the novel CAR-T cell therapy platform for cancers and immune-disorders
This is the first time that gene therapy indigenously developed by researchers at the Indian Institute of Technology (IIT), Bombay, was tested on patients in India
CAR-T cells are genetically engineered to produce an artificial T-cell receptor, which is widely used in developed nations for immunotherapy during treatment for cancer
While existing treatments work towards increasing the life of patients by a few years or months, CAR-T technology holds the promise of curing certain types of cancers. Unlike chemotherapy, this drug is administered only once to a patient.
Shreya Bhandary is a Special Correspondent covering higher education for Hindustan Times, Mumbai. Her work revolves around finding loopholes in the current education system and highlighting the good and the bad in higher education institutes in and around Mumbai....view detail
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