Varnimcabtagene autoleucel
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.
Overview
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.
1.Leukapheresis at the treating centre
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Approvals
| Region | Year | Indication |
|---|---|---|
| IN | 2024 | Relapsed or refractory B-cell lymphoma · CDSCO market authorisation as announced by Immuneel; ARI-0001 is separately approved in Spain under the hospital exemption |
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| IN | Public insurance cover not established; ask the treating centre | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Varnimcabtagene autoleucel" OR ABSTRACT:"Varnimcabtagene autoleucel" OR TITLE:"Qartemi" OR ABSTRACT:"Qartemi" OR TITLE:"IMN-003A" OR ABSTRACT:"IMN-003A" OR TITLE:"var-cel" OR ABSTRACT:"var-cel" OR TITLE:"ARI-0001" OR ABSTRACT:"ARI-0001") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Varnimcabtagene autoleucel, not a curated reading list.
Pages like this
not linked directly; found by shared links- IdeaPublic-sector CAR-T manufacturing in India, Brazil and South Africa under $50,000
Shares Talicabtagene autoleucel, Manufacturing cost and time for living and radioactive medicines, Most of the world has almost no cancer care, Acute lymphoblastic leukaemia.
- PersonRahul Purwar
Shares Point-of-care and decentralised cell manufacturing, Talicabtagene autoleucel, CD19, Manufacturing cost and time for living and radioactive medicines.
- TrialELIANA
Shares Tisagenlecleucel, Cytokine release syndrome (CRS), CD19, Manufacturing cost and time for living and radioactive medicines.
- Key paperJULIET: tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma
Shares Tisagenlecleucel, ICANS (neurotoxicity), Cytokine release syndrome (CRS), CD19.
- TrialTalicabtagene autoleucel (NexCAR19) phase 1/2
Shares Talicabtagene autoleucel, Cytokine release syndrome (CRS), CD19, Manufacturing cost and time for living and radioactive medicines.
- CompanyCellogen Therapeutics
Shares CD19, Manufacturing cost and time for living and radioactive medicines, Acute lymphoblastic leukaemia, Diffuse large B-cell lymphoma.
- InstitutionIndian Institute of Technology Bombay
Shares Point-of-care and decentralised cell manufacturing, Talicabtagene autoleucel, CD19, Manufacturing cost and time for living and radioactive medicines.
- ProductBrexucabtagene autoleucel
Shares ICANS (neurotoxicity), Cytokine release syndrome (CRS), CD19, Acute lymphoblastic leukaemia.