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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
24 enrolled.
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
SourceGrade 1 in 62.5%, grade 3 or higher in 4.2%; ICANS 4.2% (grade 1 only)
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall response rate at the primary endpointprimary | Varnimcabtagene autoleucel (IMN-003A) | 21 | 80.9% | - | - | link |
| Cytokine release syndrome, any grade | Varnimcabtagene autoleucel (IMN-003A) | 24 | 66.7% | - | - | link |
Shares Varnimcabtagene autoleucel, Point-of-care and decentralised cell manufacturing, Cytokine release syndrome (CRS), Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Manufacturing cost and time for living and radioactive medicines, Most of the world has almost no cancer care, CAR-T cell therapy.
Shares Manufacturing cost and time for living and radioactive medicines, CD19, CAR-T cell therapy, Acute lymphoblastic leukaemia.
Shares Point-of-care and decentralised cell manufacturing, Cytokine release syndrome (CRS), Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Manufacturing cost and time for living and radioactive medicines.
Shares Point-of-care and decentralised cell manufacturing, Manufacturing cost and time for living and radioactive medicines, CD19, Most of the world has almost no cancer care.
Shares Point-of-care and decentralised cell manufacturing, Cytokine release syndrome (CRS), Manufacturing cost and time for living and radioactive medicines, CD19.
Shares Point-of-care and decentralised cell manufacturing, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Manufacturing cost and time for living and radioactive medicines, CD19.
Shares CD19, CAR-T cell therapy, Acute lymphoblastic leukaemia, Diffuse large B-cell lymphoma.