{"entity":{"id":"imagine-varnimcabtagene","kind":"trial","name":"IMAGINE (varnimcabtagene autoleucel, Immuneel)","aka":[],"tldr":"The first industry-run CAR-T trial in India, testing a Bengaluru-made version of a Barcelona hospital's cell therapy in relapsed lymphoma and leukaemia; it led to the approval of Qartemi.","summary":"IMAGINE is Immuneel's phase 2 study of varnimcabtagene autoleucel (IMN-003A), the Indian version of the academic CD19 CAR-T ARI-0001 from Hospital Clinic de Barcelona, in relapsed or refractory B-cell malignancies. Results including a B-cell non-Hodgkin lymphoma subanalysis, a cytokine profile and a prognostic score (the Bengaluru Score) were presented at the International Conference on Malignant Lymphoma and ASH in 2023. The trial supported CDSCO market authorisation of Qartemi for relapsed or refractory B-cell lymphoma in 2024. Full peer-reviewed efficacy figures for the Indian cohort were not available on the linked pages at the time of writing; the Spanish programme's published results are on the product page.","status":"positive","asOf":"2026-09-10","links":[{"label":"IMAGINE B-NHL subanalysis (Hematol Oncol 2023)","url":"https://doi.org/10.1002/hon.3165_632"},{"label":"Cytokine profile (Blood 2023, ASH abstract)","url":"https://doi.org/10.1182/blood-2023-181585"},{"label":"Bengaluru Score (Blood 2023, ASH abstract)","url":"https://doi.org/10.1182/blood-2023-181120"}],"tags":[],"related":[],"cancers":["dlbcl","all-leukemia"],"sections":[],"technologies":["car-t","point-of-care-cell-manufacturing"],"targets":["cd19"],"drugs":["varnimcabtagene-autoleucel"],"companies":["immuneel"],"institutions":["narayana-health"],"pathways":[],"terms":["crs"],"trials":[],"people":[],"bottlenecks":["b-manufacturing-cell-therapy","b-global-access"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"2","setting":"Relapsed or refractory B-cell malignancies (B-cell non-Hodgkin lymphoma and B-ALL), adults, India","sponsor":"Immuneel Therapeutics","yearReported":2023,"enrolled":24,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate at the primary endpoint","primary":true,"unit":"%","arms":[{"name":"Varnimcabtagene autoleucel (IMN-003A)","n":21,"value":80.9,"note":"17 of 21 evaluable patients (B-cell NHL and B-ALL combined); 24 infused; median PFS not reached at the ASH 2023 cut, relapse in 9 of 24"}],"source":"https://doi.org/10.1182/blood-2023-181120"},{"endpoint":"Cytokine release syndrome, any grade","unit":"%","arms":[{"name":"Varnimcabtagene autoleucel (IMN-003A)","n":24,"value":66.7,"note":"Grade 1 in 62.5%, grade 3 or higher in 4.2%; ICANS 4.2% (grade 1 only)"}],"source":"https://doi.org/10.1182/blood-2023-181585"}],"replication":"Figures come from ASH 2023 abstracts, not a full paper. The Indian product is the ARI-0001 construct from Hospital Clinic de Barcelona, whose CART19-BE-01 trial and compassionate-use series (including a 2026 mantle cell lymphoma report, ORR 89%) show similar activity and low rates of severe CRS, so the Bengaluru result replicates the Spanish programme in a new manufacturing site rather than an independent design."},"route":"/trials/imagine-varnimcabtagene/","neighbours":{"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/"}],"drug":[{"id":"varnimcabtagene-autoleucel","kind":"drug","name":"Varnimcabtagene autoleucel","route":"/drugs/varnimcabtagene-autoleucel/"}],"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/"}],"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/"}],"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/"}]}}