# Varnimcabtagene autoleucel

Source: https://onco.cc/drugs/varnimcabtagene-autoleucel/  
OnCo record `varnimcabtagene-autoleucel` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

India's second approved CAR-T therapy, a Bengaluru-made version of a Spanish hospital's academic CD19 cell therapy, for lymphoma that has come back after other treatments.

## Summary

Varnimcabtagene autoleucel (var-cel) is the international nonproprietary name of ARI-0001, the CD19 CAR-T developed at Hospital Clinic de Barcelona and approved in Spain under the hospital exemption; Immuneel Therapeutics licensed it for India as IMN-003A and manufactures it at Narayana Health City in Bengaluru. Immuneel's phase 2 IMAGINE study, described as the first industry-sponsored CAR-T trial in India, treated adults with relapsed or refractory B-cell malignancies and was reported at ASH 2023 and in Hematological Oncology. On the strength of it Qartemi received CDSCO market authorisation in 2024 for relapsed or refractory B-cell lymphoma.

In Spain the same cell product has reported an 84.4% complete response with undetectable measurable residual disease by day 28 in 32 adults with relapsed B-ALL (CART19-BE-02, Lancet Haematology 2026), 100% response in follicular lymphoma and 89% in mantle cell lymphoma (HemaSphere 2025-26). Qartemi and NexCAR19 together give India two locally made CD19 CAR-Ts competing on price, something no other lower-middle-income country has.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Also known as: var-cel; IMN-003A; ARI-0001
- Brand: Qartemi
- Code: IMN-003A
- Modality: CAR-T (CD19, academic origin)
- Mechanism: Autologous T cells transduced with a lentiviral anti-CD19 (A3B1 scFv) CAR with 4-1BB and CD3-zeta domains; academic point-of-care design from Hospital Clinic de Barcelona.
- Approvals: IN 2024: Relapsed or refractory B-cell lymphoma

## Sources

- Immuneel Therapeutics: https://www.immuneel.com
- IMAGINE study cytokine analysis (ASH 2023): https://doi.org/10.1182/blood-2023-181585
- IMAGINE B-NHL subanalysis (Hematol Oncol 2023): https://doi.org/10.1002/hon.3165_632
- ARI-0001 academic CAR-T review (Br J Haematol 2023): https://doi.org/10.1111/bjh.19170

## Connected records

- drugs: [Talicabtagene autoleucel](https://onco.cc/drugs/talicabtagene-autoleucel/), [Tisagenlecleucel](https://onco.cc/drugs/tisagenlecleucel/)
- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/), [Point-of-care and decentralised cell manufacturing](https://onco.cc/technologies/point-of-care-cell-manufacturing/)
- targets: [CD19](https://onco.cc/targets/cd19/)
- companies: [Immuneel Therapeutics](https://onco.cc/companies/immuneel/)
- institutions: [Narayana Health (Mazumdar Shaw Medical Centre)](https://onco.cc/institutions/narayana-health/)
- terms: [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [ICANS (neurotoxicity)](https://onco.cc/terms/icans/)
- trials: [IMAGINE (varnimcabtagene autoleucel, Immuneel)](https://onco.cc/trials/imagine-varnimcabtagene/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/), [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/)
- key papers: [The academic point-of-care anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel (ARI-0001 cells) shows efficacy and safety in the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma](https://onco.cc/key-papers/paper-martinez-cibrian-br-j-haematol/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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