Talicabtagene autoleucel

Talicabtagene autoleucel (NexCAR19) is an autologous CD19-directed CAR-T therapy with a humanised binder developed at IIT Bombay (Rahul Purwar) with Tata Memorial Centre and manufactured by ImmunoACT in Mumbai. The open-label phase 1/2 study enrolled 64 patients (14 in phase 1, 50 in phase 2) with relapsed or refractory B-cell lymphoma or B-cell acute lymphoblastic leukaemia at six Indian centres; among 51 evaluable patients the overall response rate was 73% (37 of 51; 95% CI 59-83), grade 3 or worse neutropenia occurred in 96%, and there were two treatment-related deaths. The DCGI granted market authorisation in 2023, the first CAR-T approval in India and one of the first in any lower-middle-income country.

The product's significance is economic as much as clinical: ImmunoACT reports more than 600 patients treated at over 130 centres, a 98% manufacturing success rate and about 20 days from apheresis to infusion, at a price reported to be around a tenth of that of US products. The company's real-world series and a 2026 distribution deal with Cipla for Africa make it the test case for whether autologous cell therapy can reach middle-income countries at scale.

Schematic of the modality · CAR-T (CD19, humanised) · not a molecule; see the CAR-T cell therapy page

How it works, step by step · animated schematic, not to scale

CAR-T cell therapy →

Mechanism, step by step

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1.Leukapheresis collects the patient's T cells at an authorised centre

Modality

CAR-T (CD19, humanised)

Mechanism

Autologous T cells transduced with a lentiviral humanised anti-CD19 scFv CAR with 4-1BB costimulation and CD3-zeta signalling; expand in vivo and kill CD19-positive B cells after lymphodepletion.

Brand / code

NexCAR19 · NexCAR19

Dosing & schedule

Route: Single IV infusion after lymphodepletion
Schedule: Phase 2 dose at least 5 x 10^6 CAR-T cells per kg (up to 2 x 10^9 cells)
Monitoring: Cytokine release syndrome, neurotoxicity, prolonged cytopenias, infection, haemophagocytic lymphohistiocytosis-like syndrome

Source: doi.org/10.1016/S2352-3026(24)00377-6. Doses are for orientation; the current label governs.

Where it is approved

USEUUKJPCNAUIN2023 compare regions →

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Regulatory

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2023ApprovalIN
CDSCO/DCGI market authorisation; the developer's page gives the year only source

Approvals

Region	Year	Indication
IN	2023	Relapsed or refractory B-cell lymphoma and B-cell acute lymphoblastic leukaemia · DCGI market authorisation; first CAR-T approved in India

Safety

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Toxicity profile

Adverse event	Any grade	Grade 3+
Neutropenia (grade 3 or worse)	—	96%
Thrombocytopenia (grade 3 or worse)	—	65%
Anaemia (grade 3 or worse)	—	61%

Phase 1/2, 64 patients. Rates read from the source. Blank cells mean the figure was not sourced, not that it is zero.

Cost & access

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Cost & access

Country	Reimbursement	List price	Assistance
IN	Public insurance cover not established; ask the treating centre about state and charitable funding	Priced by the developer at a small fraction of US CAR-T prices; no figure is published on the linked page	—

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov

Talicabtagene autoleucel

intervention: Talicabtagene autoleucel

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Landmark trials in OnCo

Talicabtagene autoleucel (NexCAR19) phase 1/2

Key papers

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rctLancet Haematology 2025changed practice

Talicabtagene autoleucel for relapsed or refractory B-cell malignancies: an open-label, multicentre, phase 1/2 study

A lower-middle-income country can design, manufacture, trial and approve an autologous CAR-T therapy. Response rates are in the range of first-generation Western products in similar mixed populations, at a price an order of magnitude lower, which reopens the question of what CAR-T should cost everywhere.