{"entity":{"id":"varnimcabtagene-autoleucel","kind":"drug","name":"Varnimcabtagene autoleucel","aka":["var-cel","IMN-003A","ARI-0001"],"tldr":"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.\n\nIn 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.","status":"approved","asOf":"2026-09-10","links":[{"label":"Immuneel Therapeutics","url":"https://www.immuneel.com"},{"label":"IMAGINE study cytokine analysis (ASH 2023)","url":"https://doi.org/10.1182/blood-2023-181585"},{"label":"IMAGINE B-NHL subanalysis (Hematol Oncol 2023)","url":"https://doi.org/10.1002/hon.3165_632"},{"label":"ARI-0001 academic CAR-T review (Br J Haematol 2023)","url":"https://doi.org/10.1111/bjh.19170"}],"tags":[],"related":["talicabtagene-autoleucel","tisagenlecleucel"],"cancers":["dlbcl","all-leukemia"],"sections":[],"technologies":["car-t","point-of-care-cell-manufacturing"],"targets":["cd19"],"drugs":[],"companies":["immuneel"],"institutions":["narayana-health"],"pathways":[],"terms":["crs","icans"],"trials":["imagine-varnimcabtagene"],"people":[],"bottlenecks":["b-manufacturing-cell-therapy","b-global-access"],"keyPapers":["paper-martinez-cibrian-br-j-haematol"],"journals":[],"dependsOn":[],"notes":[],"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":[{"region":"IN","year":2024,"indication":"Relapsed or refractory B-cell lymphoma","note":"CDSCO market authorisation as announced by Immuneel; ARI-0001 is separately approved in Spain under the hospital exemption"}],"mechanismSteps":["Leukapheresis at the treating centre","Lentiviral transduction and expansion in Bengaluru","Lymphodepletion, then infusion (fractionated dosing was used in the Spanish programme)","CAR-T cells kill CD19-positive lymphoma cells","Monitoring for cytokine release syndrome and neurotoxicity"],"toxicity":[],"access":[{"country":"IN","reimbursement":"Public insurance cover not established; ask the treating centre","generic":false,"source":"https://www.immuneel.com","asOf":"2026-09-10"}],"regulatoryEvents":[]},"route":"/drugs/varnimcabtagene-autoleucel/","neighbours":{"drug":[{"id":"talicabtagene-autoleucel","kind":"drug","name":"Talicabtagene autoleucel","route":"/drugs/talicabtagene-autoleucel/"},{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"}],"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"},{"id":"point-of-care-cell-manufacturing","kind":"technology","name":"Point-of-care and decentralised cell manufacturing","route":"/technologies/point-of-care-cell-manufacturing/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"}],"company":[{"id":"immuneel","kind":"company","name":"Immuneel Therapeutics","route":"/companies/immuneel/"}],"institution":[{"id":"narayana-health","kind":"institution","name":"Narayana Health (Mazumdar Shaw Medical Centre)","route":"/institutions/narayana-health/"}],"term":[{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"},{"id":"icans","kind":"term","name":"ICANS (neurotoxicity)","route":"/terms/icans/"}],"trial":[{"id":"imagine-varnimcabtagene","kind":"trial","name":"IMAGINE (varnimcabtagene autoleucel, Immuneel)","route":"/trials/imagine-varnimcabtagene/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"},{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"}],"paper":[{"id":"paper-martinez-cibrian-br-j-haematol","kind":"paper","name":"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","route":"/key-papers/paper-martinez-cibrian-br-j-haematol/"}],"roadmap":[{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"}]}}