ONCOLOGY · CELL & GENE THERAPY

CAR-T cell therapy in India

CAR-T therapy takes a patient's own immune cells, re-engineers them in a laboratory to recognise their cancer, and gives them back as a single infusion. In 2023 India approved its own CD19 CAR-T, NexCAR19, developed at IIT Bombay and Tata Memorial Centre — bringing a treatment that costs several hundred thousand dollars elsewhere within reach at roughly a tenth of the price. 1,4

CDSCO approved · Oct 2023NexCAR19 · talicabtagene autoleucelSingle infusion
CAR-T cell therapy in India
SUITABILITY

Who it is for

NexCAR19 is approved for people aged 15 and above whose B-cell acute lymphoblastic leukaemia (B-ALL) or B-cell lymphoma has come back or stopped responding after standard treatment. 1,4 It is not a first-line treatment; it is considered when chemotherapy and other options have not held the disease. A haemato-oncologist confirms suitability after reviewing your history, marrow and scans.

LIKELY ELIGIBLE

  • Relapsed or refractory B-ALL or B-cell lymphoma
  • Aged 15 or older
  • CD19-positive disease
  • Adequate organ function and performance status
  • Able to stay for collection, infusion and monitoring

LIKELY NOT ELIGIBLE

  • Disease that is not CD19-positive
  • Active, uncontrolled infection
  • Significant heart, lung, kidney or liver impairment
  • Active central-nervous-system complications (case by case)
  • Too unwell to tolerate the monitoring period
CLINICAL EVIDENCE

The evidence

These are the published results for the product actually available in India. We give the numbers and their limits together.

Read the results alongside their limits. These are relapsed, hard-to-treat cancers, and not everyone responds; among those who do, some later relapse. Follow-up is still maturing, and the paediatric figures come from a small early cohort. What CAR-T offers is a meaningful chance of deep, sometimes lasting remission where standard options have run out.

NexCAR19 pivotal trial Phase 1/2

  • 64 patients across six Indian centres with relapsed/refractory B-cell malignancies; the trial that supported approval.
  • NexCAR19 pivotal trial
  • Phase 1/2
  • Overall response rate
  • ~73%
  • Severe neurotoxicity (ICANS)
  • Low / absent
  • Main grade ≥3 effects
  • Low blood counts
  • Jain H et al. Lancet Haematol. 2025;12(4):e282–e293

Real-world results 250 patients, 56 centres

  • Patients treated in routine practice after approval — the closest picture of what to expect.
  • Real-world results
  • 250 patients, 56 centres
  • B-ALL — 12-month survival
  • 64%
  • B-ALL — 12-month progression-free
  • 55%
  • B-lymphoma — 12-month survival
  • 63%
  • Karulkar A et al. Blood Cancer J. 2026

Children & young people Paediatric B-ALL study

  • An early study of the same cell product in relapsed/refractory paediatric B-ALL.
  • Children & young people
  • Paediatric B-ALL study
  • Overall response rate
  • 91.7%
  • Complete response
  • 66.7%
  • Blood Cancer J. 2025 (small early cohort, n=12)
OUTCOMES

Benefits and limits

WHAT IT CAN DO

  • Offer a real chance of remission after other treatments have failed.
  • Work as a single infusion rather than an endless course.
  • Deliver treatment India's product carries with notably low neurotoxicity. 1
  • Cost a fraction of the same class of therapy abroad.

WHAT IT CANNOT DO

  • Guarantee a cure — some patients do not respond, and some relapse.
  • Treat cancers that do not carry the CD19 target.
  • Avoid a demanding few weeks of close inpatient monitoring.
  • Replace the judgement of a treating haemato-oncologist.
CLINICAL DETAIL

What this therapy is

CAR-T stands for chimeric antigen receptor T-cell therapy. A patient's own T-cells — part of the immune system — are collected from the blood, sent to a laboratory, and given a new receptor that lets them recognise a protein called CD19 that sits on B-cells, including the cancerous ones in certain leukaemias and lymphomas. The re-engineered cells are grown in number and infused back, where they seek out and kill the cancer.

Because the cells are made from you and multiply inside you, this is a one-time infusion rather than an ongoing course. India's approved product, NexCAR19 (talicabtagene autoleucel) , was developed over a decade by IIT Bombay and Tata Memorial Centre and manufactured by ImmunoACT; it received marketing authorisation from the drug regulator, CDSCO, on 13 October 2023 — the first CAR-T therapy designed and made in India. 1,4,5

HOW IT WORKS

  • Clinical overview

Diagram — the CAR-T journey: collect T-cells by apheresis, engineer a CD19-targeting receptor, expand the cells, then infuse them back to attack B-cell cancer.

    How a patient's own cells are turned into a living cancer treatment.

    • Your treating team can explain this process using your own scans and reports.
    CLINICAL DETAIL

    Side effects

    CAR-T has a distinctive set of side effects because the cells become active inside the body. The two best known are cytokine release syndrome and neurotoxicity; India's product has reported a favourable profile on the second. 1

    Cytokine release syndrome Common

    • Fever, low blood pressure and flu-like illness as the cells activate; usually manageable, and the reason for close monitoring in the first weeks.

    Neurotoxicity (ICANS) Reported low with NexCAR19

    • Confusion, tremor or difficulty speaking; reported as low or absent for India's product compared with some others in its class.

    Low blood counts Very common

    • Drops in neutrophils, platelets and haemoglobin were the most frequent serious effects in the trial; may need transfusion or growth-factor support.

    Infection risk Common

    • Because the therapy lowers normal B-cells and antibodies for a time; may need preventive antibiotics or antibody replacement.
    BEFORE TREATMENT

    What to prepare for

    CAR-T is a sequence, not a single day. The manufacturing wait and the inpatient monitoring are the parts families underestimate.

    01

    • A haemato-oncologist confirms the diagnosis is CD19-positive and that CAR-T is the right step, before anything is scheduled.

    02

    • Your T-cells are collected from the blood over a few hours through a machine, then sent for engineering.

    03

    • Making the cells takes roughly two to three weeks. Some patients need bridging treatment to hold the cancer steady meanwhile.

    04

    • A short course of chemotherapy prepares the body, then the engineered cells go back in a single infusion.

    05

    • Expect two to four weeks in or near the hospital afterwards, with an adult caregiver present. Driving and travel are restricted for several weeks.
    INDICATIVE COST

    Cost in India

    Therapy, from $36,000

      INCLUDED The CAR-T product and its manufacture Cell collection and the infusion Lymphodepletion chemotherapy Inpatient monitoring for the standard period

      • The CAR-T product and its manufacture
      • Cell collection and the infusion
      • Lymphodepletion chemotherapy
      • Inpatient monitoring for the standard period
      • Bridging treatment before infusion, if needed
      • Prolonged ICU or complications (per-day)
      • Flights, visa and accommodation
      • Treatment of unrelated conditions

      4

        NETWORK

        Where it is done

        CAR-T requires an authorised centre with the laboratory, haematology and intensive-care support needed during treatment and monitoring. Centre authorisation and current product availability are confirmed for each enquiry before a hospital is recommended.

        FAQ

        Questions patients ask

        Is CAR-T available in India, or only abroad?

        It is available in India. India's own CD19 CAR-T, NexCAR19, was approved in October 2023 and is offered at a growing number of authorised centres. 1,4

        Which cancers can it treat?

        It is approved for relapsed or refractory B-cell acute lymphoblastic leukaemia and B-cell lymphoma in people aged 15 and above. It is not used for solid tumours.

        Why is it so much cheaper here?

        NexCAR19 was developed and is manufactured in India, which brings the price to roughly a tenth of approved products abroad — from about US$36,000 rather than several hundred thousand. 4

        How long will I need to stay?

        Plan for several weeks: cell collection, roughly two to three weeks of manufacturing, then infusion and two to four weeks of close monitoring, with a caregiver present throughout.

        Is it dangerous?

        It carries real risks — cytokine release syndrome, low blood counts and infection — which is why monitoring is intensive. Notably, India's product has reported low neurotoxicity compared with some others in its class. 1

        SOURCES

        References

        Every clinical claim on this page traces to one of these. Where we could not source a figure from peer-reviewed literature or the approved label, we have left it out rather than estimate it.

        This page is written for patients and their families and is not medical advice. Health Route is a facilitator, not a healthcare provider. Eligibility, dosing and risk are decisions for a treating haemato-oncologist who has examined you and reviewed your reports.

        1

        Jain H, Karulkar A, Kalra D, et al. Talicabtagene autoleucel for relapsed or refractory B-cell malignancies: an open-label, multicentre, phase 1/2 study.

        Lancet Haematology, 2025;12(4):e282–e293. doi:10.1016/S2352-3026(24)00377-6. 64 patients, six centres; ~73% overall response; grade ≥3 effects mainly haematological; low neurotoxicity.

        2

        Karulkar A, Jain H, Sidharthan N, et al. Real-world evidence on talicabtagene autoleucel: delivery, efficacy and safety.

        Blood Cancer Journal, 2026. doi:10.1038/s41408-026-01569-w. 250 patients across 56 centres; B-ALL 12-month OS 64% / PFS 55%; B-NHL 12-month OS 63% / PFS 47%.

        3

        Humanised CD19 CAR-T (talicabtagene autoleucel) in relapsed/refractory paediatric B-ALL: phase 1/1b study.

        Blood Cancer Journal, 2025. doi:10.1038/s41408-025-01279-9. Small early cohort (n=12): overall response 91.7%, complete response 66.7%.

        4

        CDSCO marketing authorisation of NexCAR19 (talicabtagene autoleucel), 13 October 2023 — ImmunoACT, with IIT Bombay and Tata Memorial Centre.

        India's first indigenous CD19 CAR-T; approved age 15+; priced at roughly one-tenth of global CAR-T products; available across 30+ hospitals in ~12 cities.

        5

        Talicabtagene Autoleucel: First Approval.

        Molecular Diagnosis & Therapy, 2024. doi:10.1007/s40291-024-00719-9. Development history and indication summary.

        Contact us about your records

        A haemato-oncologist reads them and writes back after the treating team completes its review with whether CAR-T is a realistic option for you, what the path would look like, and an itemised price. No charge, and no obligation to travel.