Talicabtagene autoleucel
Talicabtagene autoleucel, sold under the brand name NexCAR19™, is a chimeric antigen receptor (CAR) T cell therapy used for the treatment of B-cell lymphomas and B-cell acute lymphoblastic leukaemia (B-ALL) in adult and adolescent patients who have failed frontline or subsequent therapies. It is the first commercially approved CAR-T cell therapy developed in India. It involves the genetic modification of a patient's own T cells with an engineered vehicle called a lentiviral vector, that enables the T cells to express the CAR gene specifically target CD19, which is commonly present on the surfaces of B-cells. These modified CAR-T cells are expanded and reinfused into the patients, where they selectively recognize and eliminate CD19-expressing B cells in an antigen-dependent manner.
Unlike earlier murine-based CAR constructs, talicabtagene autoleucel is a humanized CAR-T cell therapy designed for improved patient tolerance. Its humanized nature aims to minimize cytokine release, thereby reducing the occurrence and severity of side effects like cytokine release syndrome (CRS).1[1] Talicabtagene autoleucel is priced at about one-tenth of the cost of comparable CD19 CAR-T cell therapies available internationally.2[2] Economic evaluations have shown reduced overall healthcare-utilization costs, attributed in part to its lower incidence of severe toxicities and minimal requirement for intensive care support.3[3],4[4]
Medical uses Talicabtagene autoleucel is indicated for the treatment of:
- Relapsed or refractory B-cell acute lymphoblastic leukaemia (B-ALL)
- Relapsed or refractory B-cell lymphomas
in patients aged ≥15 years who have failed frontline or subsequent therapies.
Adverse effects Common adverse reactions include fever, nausea, vomiting, shortness of breath, pain, low blood pressure, and the depletion of certain components of the blood such as platelets (thrombocytopenia), neutrophils (neutropenia), cytokine release syndrome (CRS),[5] and anaemia. Rarer side effects may include neurotoxicity or immune-effector cell associated HLH-like syndrome (IEC-HS).[6]
History Research on an indigenous CAR-T cell platform in India began in 2015 at the Immunoengineering Lab, Bioscience and Bioengineering department, IIT Bombay,[7] led by Prof. Rahul Purwar and his team, including doctoral students Alka Dwivedi, PhD & Atharva Karulkar, PhD. At that time, early successes of international products (tisagenlecleucel and axicabtagene ciloleucel) highlighted the therapeutic potential of CAR-T cells but also underscored challenges related to high manufacturing costs and limited accessibility in low- and middle-income countries (LMICs).
The IIT Bombay team developed a humanized anti-CD19 CAR construct showing potent activity and favourable tolerability in preclinical models. To enable clinical translation, the group partnered with oncologists Gaurav Narula and Hasmukh Jain at the Tata Memorial Centre in Mumbai. Additional scientific guidance was provided by international CAR-T experts, including Nirali N. Shah (NCI), Carl H. June[8] (University of Pennsylvania),[9] and Sattva Neelapu (MD Anderson Cancer Center). 8,9 To support late-stage development and manufacturing, the research group founded ImmunoACT,[10] a cell and gene therapy company based in Navi Mumbai. ImmunoACT conducted the pivotal Phase I/II studies and now manufactures the therapy commercially.
Talicabtagene autoleucel received market authorization from the Central Drugs Standard Control Organisation (CDSCO)[11] in October 2023, becoming India's first approved CAR-T or gene-modified cell therapy. It was formally dedicated by the President of India in 2024.[12]
Clinical research Phase I/II clinical studies published in The Lancet Haematology reported that talicabtagene autoleucel achieved an overall response rate of 73% in efficacy-evaluable adults and adolescents with relapsed or refractory B-cell malignancies. The therapy showed a manageable safety profile and a low incidence of high-grade cytokine release syndrome. The studies also noted comparatively low healthcare-resource utilization, a factor of relevance in LMIC settings. In paediatric patients with relapsed or refractory B-ALL, talicabtagene autoleucel demonstrated an overall response rate of 91.7%, with complete responses observed in 66.7% of treated children, particularly at higher dose levels.
Real-world outcomes in India Real-world data from post-approval use in India showed an overall response rate of 88% in patients with B-ALL, with a complete response rate of 86%. At 12 months, progression-free and overall survival rates were 68% and 72%, respectively. Severe cytokine release syndrome occurred in 5% of patients and immune-effector cell–associated neurotoxicity (ICANS) in 4-9%, with only about 7% requiring intensive-care support. These findings suggest that talicabtagene autoleucel can serve as a definitive therapy for many patients without the need for consolidation allogeneic stem-cell transplantation.[13] Society and cost Talicabtagene autoleucel is priced at roughly one-tenth the cost of internationally marketed CD19 CAR-T therapies, a difference attributed to integrated domestic manufacturing, lower labour and infrastructure expenses, and bioprocesses designed for LMIC settings.[14][15][16]
References
- ↑ Mallapaty, Smriti (March 21, 2024). "Cutting-edge CAR-T cancer therapy is now made in India — at one-tenth the cost". Nature. 627 (8005): 709–710. doi:10.1038/d41586-024-00809-y – via www.nature.com.
- ↑ "Excellent Safety Profile of a Low-Cost Novel Humanized CD19 CAR T-Cell Therapy, Actalycabtagene Autoleucel : Potential Impact on Access and Feasibility | Blood | American Society of Hematology".
- ↑ "Novel humanized anti-cd19 chimeric antigen receptor, its nucelic acid sequence and its preparation".
- ↑ Karulkar, Atharva; Jaiswal, Ankesh Kumar; Khan, Aalia; Kalra, Devanshi; Ravikumar, Smrithi; Ghandade, Netra; Patil, Ruchira; Shah, Shreshtha; Firfiray, Afrin; Pendhari, Juber; Patil, Rushikesh; S, Manivasagam; Thorat, Jayshree; Sharma, Neha; Shetty, Alok; Eipe, Thomas; Nayak, Lingaraj; Bagal, Bhausaheb; Sengar, Manju; Narula, Gaurav; Shah, Nirali N.; Neelapu, Sattva S.; Jain, Hasmukh; Purwar, Rahul (November 2, 2023). "Excellent Safety Profile of a Low-Cost Novel Humanized CD19 CAR T-Cell Therapy, Actalycabtagene Autoleucel : Potential Impact on Access and Feasibility". Blood. 142: 257. doi:10.1182/blood-2023-177594 – via ScienceDirect.
- ↑ "Cytokine release syndrome". October 9, 2025 – via Wikipedia.
- ↑ Hines, Melissa R.; Knight, Tristan E.; McNerney, Kevin O.; Leick, Mark B.; Jain, Tania; Ahmed, Sairah; Frigault, Matthew J.; Hill, Joshua A.; Jain, Michael D.; Johnson, William T.; Lin, Yi; Mahadeo, Kris M.; Maron, Gabriela M.; Marsh, Rebecca A.; Neelapu, Sattva S.; Nikiforow, Sarah; Ombrello, Amanda K.; Shah, Nirav N.; Talleur, Aimee C.; Turicek, David; Vatsayan, Anant; Wong, Sandy W.; Maus, Marcela V.; Komanduri, Krishna V.; Berliner, Nancy; Henter, Jan-Inge; Perales, Miguel-Angel; Frey, Noelle V.; Teachey, David T.; Frank, Matthew J.; Shah, Nirali N. (July 1, 2023). "Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome". Transplantation and Cellular Therapy, Official Publication of the American Society for Transplantation and Cellular Therapy. 29 (7): 438.e1–438.e16. doi:10.1016/j.jtct.2023.03.006. PMID 36906275 Check
|pmid=value (help) – via www.astctjournal.org. - ↑ "IIT Bombay". December 9, 2025 – via Wikipedia.
- ↑ "Carl H. June". November 18, 2025 – via Wikipedia.
- ↑ "University of Pennsylvania". December 12, 2025 – via Wikipedia.
- ↑ "ImmunoACT | CAR-T Cell Therapy & Cancer Treatment in India". ImmunoACT.
- ↑ Bureau, The Hindu (October 13, 2023). "CDSCO approves ImmunoACT's CAR-T cell therapy" – via www.thehindu.com.
- ↑ https://pib.gov.in/PressReleasePage.aspx?PRID=2017169
- ↑ "Talicabtagene autoleucel for relapsed or refractory B-cell malignancies: results from an open-label, multicentre, phase 1/2 study". The Lancet. Haematology. 12 (4): e282–e293. April 15, 2025. doi:10.1016/S2352-3026(24)00377-6. PMID 40090352 Check
|pmid=value (help) – via PubMed. - ↑ Jayaraman, Killugudi (December 15, 2019). "Cut-price CAR-T cell therapies top India's biotech agenda". Nature Biotechnology. 37 (12): 1388–1389. doi:10.1038/s41587-019-0346-1. PMID 31796924 – via PubMed.
- ↑ Jain, Hasmukh; Karulkar, Atharva; Kalra, Devanshi; Ravikumar, Smrithi; Shah, Shreshtha; Firfiray, Afrin; Pendhari, Juber; S, Manivasagam; Vaibhaw, Anand; Saroha, Ashish; Jaiswal, Ankesh K.; Shetty, Alok; Nayak, Lingaraj; Bagal, Bhausaheb; Siddharthan, Neeraj; Kaul, Esha; Mehta, Prashant; Gupta, Anshul; Khattry, Navin; Jindal, Nishant; Shah, Sanket P; Boya, Rakesh Kumar; Boyella, Pavan Kumar; Desai, Preeti; Navkudkar, Anisha; Purwar, Shalini; Sengar, Manju; Shah, Nirali N.; Neelapu, Sattva S.; Purwar, Rahul (November 5, 2024). "Real World Data of Novel Talicabtagene Autoleucel (humanized CD19 CAR-T) from India; Ensuring Equitable Access with Excellent Safety and Efficacy Profile". Blood. 144: 3755. doi:10.1182/blood-2024-202335 – via ScienceDirect.
- ↑ "Talicabtagene autoleucel (humanized CD19 CAR-T) as a second line therapy in r/r B-cell lymphoma: sub-analysis from a phase I/II trial". scholar.google.com.
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