Qartemi: India’s Second Approved CAR-T Therapy

Qartemi is the brand name of varnimcabtagene autoleucel, an autologous CD19-directed CAR-T cell therapy made by Immuneel Therapeutics in Bengaluru. It is licensed from Hospital Clínic de Barcelona, where the construct was developed as ARI-0001. India’s drug regulator approved it in January 2025, making it the country’s second approved CAR-T therapy.

Two Indian CAR-T products now exist, and both are priced far below the global figures families read about first. Very little plain-language material has followed. This page is an orientation to the second of them.

CAR-T is not a medicine in a vial. It is a living product built from the patient. T cells are collected from the blood, taken to a laboratory, given a new gene so they display a chimeric antigen receptor on their surface, grown until there are enough of them, then returned to the same patient. The receptor is aimed at CD19, a protein carried on B cells — including the cancerous ones in B-cell lymphoma.

The origin story matters here, because it is unusual. The construct behind Qartemi came out of an academic programme at Hospital Clínic de Barcelona and the IDIBAPS research institute, where it is known as ARI-0001. Immuneel signed a development and licensing agreement with them in 2020, then ran the Indian clinical programme and built manufacturing in Bengaluru. So the product carries data from a European academic setting and from Indian hospitals, rather than from one country alone.

One design detail is worth knowing, because it is the difference the company itself points to. Qartemi is a second-generation product with a 4-1BB co-stimulatory domain and a non-FMC63 binder called A3B1, and the dose is given in three fractions rather than one, which is described as an added safety measure in the product information.

In India, Qartemi is approved for one group of cancers: relapsed or refractory B-cell non-Hodgkin lymphoma, in patients aged over 18 years. It is not approved here for solid tumours, not for myeloma, and not as a first-line treatment. Acute lymphoblastic leukaemia is a separate question, set out in the table below.

The Indian product information states the indication as B-cell non-Hodgkin lymphoma rather than listing every subtype. Whether a particular diagnosis sits inside that wording is a judgement the treating haematologist makes from the biopsy, the immunohistochemistry and the treatment history — not something a web page can settle.

The Indian approval rested on the phase 2 IMAGINE trial, run at hospitals across India. Reported outcomes included an overall response rate of 83.3 per cent at 90 days among patients who received the therapy. That is a group figure, from a selected population, at one early time point. It describes what happened in a trial. It does not predict any one person’s result.

How to read that number honestly

• An overall response rate counts patients whose lymphoma shrank or became undetectable on assessment. It is not the same as staying in remission.
• Ninety days is early. A response at three months says nothing on its own about year two or year five.
• Trial populations are selected. Organ function, performance status and disease that can wait for manufacturing all shape who is enrolled.
• The figure counts patients who actually received the infusion. Some people who start the pathway never reach it.
• No survival figure appears on this page, and no survival figure should decide a treatment. That conversation belongs with your haematologist, working from your own reports.

Response rate as reported in coverage of the CDSCO approval published by AABB in January 2025, and in the manufacturer’s published material. Response rates on this page are described, not promised. Long-term outcome data for this product in Indian patients is still accumulating, and honest uncertainty is the correct answer where it does not yet exist.

Most patients with cancer, including most patients with lymphoma, are not candidates for this therapy. That is the honest starting point, and it is worth saying before anything else on this page is read as an option.

• Anyone whose cancer is not a CD19-positive B-cell lymphoma. The receptor is aimed at CD19. If the cancer does not carry that target, the therapy has nothing to attach to.
• Children and adolescents under 18. The Indian indication is adults only.
• People with solid tumours — breast, lung, colon, head and neck and the rest. CAR-T is not a solid-tumour treatment in routine Indian practice.
• People with multiple myeloma. Myeloma CAR-T is a different target, BCMA, and a different set of products.
• Patients who have not yet had the standard earlier lines of treatment. Qartemi sits in the relapsed or refractory setting, not at diagnosis.
• Patients whose organ function, performance status or active infection makes intensive therapy unsafe. Cell-therapy centres assess heart, lung, kidney, liver and marrow function before accepting anyone, and a proportion of referrals are declined on those grounds.
• Patients whose disease is moving too fast to wait. Manufacturing takes weeks. Where lymphoma is progressing rapidly and bridging treatment cannot hold it, the pathway may not be realistic.
• Anyone for whom the practical scaffolding is not in place — weeks near an accredited centre, a caregiver, funds arranged in advance. This is not a small consideration; it decides many cases.

Eligibility for Qartemi is decided only by a haematologist or cell-therapy team working from your own reports, marrow studies, scans and treatment history — never from a web page, and never from a price list.

Qartemi is one treatment course, not a series of cycles. Every step happens at an accredited cell-therapy centre, and the whole pathway runs over weeks rather than days.

1. Referral and assessment. A haematologist confirms the diagnosis and CD19 status, reviews earlier lines of treatment, and checks organ function and fitness.
2. Leukapheresis. T cells are collected from the blood over a session lasting a few hours. The cells go to the manufacturing facility.
3. Manufacturing. The cells are genetically modified to display the CD19-directed receptor and grown to a treatment dose in Bengaluru. This takes weeks, not days.
4. Bridging treatment, if needed. Some patients are given interim treatment to hold the disease steady while the product is being made.
5. Lymphodepleting chemotherapy. A short course over a few days before infusion, to make room for the modified cells.
6. Infusion, in three fractions. The dose is weight-based — between 0.1 million and 5 million CAR-positive viable T cells per kilogram — and it is dispensed as 10 per cent, 30 per cent and 60 per cent across three bags of roughly 30 ml.
7. Inpatient monitoring, then follow-up. The admission covers the period when reactions are most likely, and follow-up continues for months afterwards.

Because the dose is calculated per kilogram and the product is a living cell preparation, CAR-T cannot be given at a day-care unit or an ordinary hospital ward. It needs an apheresis service, a trained cell-therapy team and intensive care on the same site.

The two reactions that define CAR-T safety are cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, usually shortened to CRS and ICANS. Both carry a formal warning in the product information. Both can be severe. Both are managed inside the treating centre, which is one reason the admission exists.

The manufacturer’s patient information asks anyone who has received this therapy to contact their treating team immediately if they develop fever of 38 °C (100.4 °F) or higher, chills or shaking chills, confusion, severe nausea, vomiting or diarrhoea, severe muscle or joint pain, very low blood pressure, dizziness or light-headedness, or headache. These are reported, not self-managed.

The same information is explicit on a point that matters in Indian households: do not treat these symptoms with over-the-counter medicines or with herbal or dietary supplements without the treating team’s approval. If a family is already using an Ayurvedic, homeopathic or other traditional preparation, the useful step is to tell the haematologist what it is, so interactions and timing can be judged properly. Disclosure, not concealment, is what protects the patient.

Because CD19 sits on healthy B cells as well as cancerous ones, antibody levels can stay low for a long period afterwards, and some patients need immunoglobulin replacement. Prolonged low blood counts and infection risk are also recognised. Long-term effects after CD19 CAR-T, including fertility and any second-cancer risk, are areas where the evidence remains immature; a centre that says so plainly is being accurate, not evasive.

Reporting published by AABB in January 2025, at the time of the Indian approval, said Immuneel expected the therapy to cost around 60,000 US dollars per dose, against reported US prices upwards of 400,000 US dollars per dose. Indian coverage around the launch quoted figures in the region of 35 lakh to 60 lakh rupees, varying by source. These are indicative, as of August 2026.

Every figure above comes from published reporting and manufacturer material. None of it is a rate card, and none of it is a CION price — CION does not sell this product and has no price for it. The number that matters to a family is the one the treating centre puts in writing.

The product price is also not the whole bill. Apheresis, bridging treatment, lymphodepleting chemotherapy, the hospital admission, intensive care if it becomes necessary, supportive medicines such as tocilizumab, and weeks of travel and accommodation near the centre are billed separately. Ask the treating centre for a written, itemised estimate before anything is scheduled, and ask what happens to the money already spent if manufacturing fails or the patient becomes unfit before infusion. Qartemi Cost and Access goes through the bill and the funding routes in detail.

Both are Indian-made, autologous, CD19-directed CAR-T therapies. NexCAR19 from ImmunoACT was approved in October 2023 and was India’s first. Qartemi from Immuneel followed in January 2025. They differ in the approved age range, in the indications covered, in the receptor design and in where the construct came from.

The practical differences that reach a family are usually three: which indication each approval actually covers, which centres are set up to deliver each product, and what each one costs once the full bill is counted. Those are centre-level facts, and they change; the treating haematologist will know the current position for your diagnosis better than any page can.

A side-by-side reading of the two products, including design and approval scope, is set out in NexCAR19 vs Qartemi: How the Two Indian CAR-T Products Compare. For the first product on its own, see NexCAR19: India’s First CAR-T Therapy Explained.

If the real question behind your search is money, read Qartemi Cost and Access, which breaks the bill into its parts and covers what insurance and schemes have and have not paid.

If you are weighing the two Indian products against each other, NexCAR19 vs Qartemi compares them directly. If the diagnosis in your family is myeloma rather than lymphoma, Qartemi is the wrong target altogether and CAR-T for Myeloma in India: Where BCMA Therapy Stands is the page to read instead.

For the wider view across checkpoint inhibitors, biosimilars and the other classes of immune treatment, start from Immunotherapy Medicines Explained, or from the main immunotherapy section.