Qartemi (varnimcabtagene autoleucel) / August Pi i Sunyer Biomedical Research Institute, Immuneel Therap - LARVOL DELTA

VARNIMCABTAGENE AUTOLEUCEL (VAR-CEL) IN RELAPSED / REFRACTORY CD19+ NON-HODGKIN LYMPHOMA (EHA 2023) - P1 | "Background: Varnimcabtagene autoleucel (var-cel, ARI-0001 cells), an academic second generation anti-CD19 CAR T-cell, has been granted hospital exemption use by the AEMPS and PRIME designation by the EMA for patients >25 years old with relapsed or refractory (R/R) B cell acute lymphoblastic leukaemia (B-ALL) based on the results of the CART19- BE-01 clinical trial (NCT03144583)...Patients underwent lymphodepletion with fludarabine (30mg/m 2 ) and cyclophosphamide (300mg/m 2 )... High percentage of included patients received var-cel treatment. Var-cel had an acceptable safety profile in adult patients with R/R CD19+ NHL. Efficacy results may be comparable to other commercial CD19 CAR T cell products."

Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock • Steven-Johnson Syndrome • Thrombocytopenia • Transplantation • CD34

Varnimcabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia in Spain (CART19-BE-02): a multicentre, single-arm, phase 2 trial. (PubMed, Lancet Haematol) - P2 | "Var-cel induced deep remissions with low incidence of severe cytokine release syndrome and any-grade immune effector cell-associated neurotoxicity syndrome, supporting fractionated dose escalation as a strategy that preserves activity, limits acute toxic effects, and supports a hospital-based approach that could expand access to CAR T-cell therapy."

Journal • P2 data • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Inflammation • Leukemia • Neutropenia • Novel Coronavirus Disease • Oncology • Rare Diseases • Septic Shock • Thrombocytopenia • Transplantation

Efficacy and safety of the academic anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel for the treatment of relapsed/refractory follicular lymphoma. (PubMed, Hemasphere) - P1 | "In conclusion, patients with R/R FL treated with var-cel obtained excellent disease control, with prolonged CAR T-cell survival and manageable toxicity. This trial was registered as NCT03144583."

Journal • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Bridging the East-West Divide in Access to CAR-T Therapy in Europe: Romania as a Case Study for Structural Inequities and Scalable Solutions (SOHO 2026) - "Conversely, Spain's academic CAR-T therapy (ARI-0001, Hospital Clínic Barcelona) delivers effective therapy at one-third the cost of commercial products, with nearly 300 patients treated... Reducing CAR-T therapy access disparities requires coordinated interventions: (1) implementation of the European Union's HTA Regulation to accelerate reimbursement harmonization; (2) regional GMP-compliant ATMP manufacturing investment, including academic point-of-care models inspired by the Spanish experience—such as the emerging ATMP-HUB in Romania developed with IRCCS San Raffaele; (3) harmonized JACIE-based center qualification; and (4) expanded cross-border referral and clinical trial networks. Without targeted intervention, access to CART therapy risks remaining determined by geography rather than clinical need. ATMP: advanced therapy medicinal products; CAR-T: chimeric antigen receptor T-cell; EBMT: European Registry for Blood and Marrow Transplantation; GMP: Good..."

CAR T-Cell Therapy • Case study • Clinical • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

CD70 Overexpression at Diagnosis Predicts Relapse and supports dual CD19-CD70 CAR-T Therapy in Follicular Lymphoma. (PubMed, Blood) - "To target these cells and enhance current CAR-T approaches, we engineered dual CD19-CD70 chimeric antigen receptor (CAR) T cells by co-transducing the CD19-CAR-T ARI-0001 with a CD27-based anti-CD70 CAR...In FL xenograft models, dual CAR-T treatment achieved superior disease control compared to monotargeted CAR-T cells, inducing complete tumor clearance in spleen and bone marrow. Collectively, these findings provide strong preclinical rationale for the clinical development of CD19-CD70 dual CAR-T therapy to improve outcomes in high-risk FL and potentially other B-cell non-Hodgkin lymphomas."

IO biomarker • Journal • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD27 • CD4 • CD70 • CD8

Immuneel Therapeutics…has announced a strategic partnership with Arogya Finance to introduce India's first Zero Cost EMI programme of up to Rs 25 lakh for eligible patients undergoing treatment with Qartemi (Varnimcabtagene autoleucel), Immuneel's CD19-directed autologous CAR-T cell therapy (BioSpectrum India) - "The partnership has been formalised through a collaboration agreement under which Arogya Finance will independently provide financing to eligible patients, while Immuneel continues to focus on delivering world-class CAR-T therapy. Under the programme, every patient first undergoes a comprehensive medical evaluation by Immuneel's Medical Affairs team to determine eligibility for CAR-T cell therapy. Eligible patients are then supported through the Saksham Desk, which provides dedicated financial counselling and facilitates the financing process....Qartemi (Varnimcabtagene autoleucel) is Immuneel's CD19-directed autologous CAR-T cell therapy developed for eligible patients with relapsed or refractory B-cell malignancies."

Commercial • B Cell Non-Hodgkin Lymphoma

Varnimcabtagene autoleucel (ARI-0001) in relapsed or refractory mantle cell lymphoma. (PubMed, Hemasphere) - "With a median follow-up of 21.7 months, median overall survival was 35.2 months. In this multicenter academic experience, var-cel demonstrated high antitumor activity with low rates of severe CRS and ICANS, supporting its use within a coordinated national network."

Journal • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

CART19-BE-03Ped: Phase 2 study of the infusion of differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z (ARI-0001 cells) in children and adolescents aged 0-18 years with CD19+ acute lymphoblastic leukaemia resistant or... (clinicaltrialsregister.eu) - P1/2 | N=33 | Active, not recruiting | Sponsor: Fundacio Sant Joan De Deu | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • KMT2A • TCF3 • TP53

India’s first CAR T-Cell therapy shows durable results (ExpressPharma) - "The CAR T-cell therapy, known as Varnimcabtagene autoleucel (IMN-003A), under Immuneel’s IMAGINE Phase 2 clinical trial, aimed at treating adult patients with relapsed or refractory CD19- positive B-cell Non-Hodgkin Lymphoma (B-NHL)....The encouraging results of the therapy recorded an 83% overall response rate (ORR) at Day 90 and a 50% ORR at Day 365, with a complete response rate of 83%, placing it among the highest reported outcomes in Indian clinical benchmarks for CAR T-cell therapies. The therapy has now been administered to more than 100 patients in India, marking Immuneel’s successful scale-up in delivering this complex therapy with consistent outcomes and a favorable safety profile."

P2 data • Trial status • B Cell Non-Hodgkin Lymphoma

CART19-BE-02: Study of the Infusion of ARI-0001 Cells in Patients With CD19 + Acute Lymphoid Leukemia Resistant or Refractory to Therapy (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: Sara V. Latorre | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

IMMUNE EFFECTOR CELL ASSOCIATED NEUROTOXICITY (ICANS) IN PAEDIATRIC PATIENTS FOLLOWING CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPY: EXPERIENCE FROM A TERTIARY CARE CENTER (EBMT 2026) - "ICANS treatment included intravenous anakinra 10mg/kg/8hours (16/24; 67%), siltuximab (9/24; 38%), and corticosteroids (10/24; 42%), mainly methylprednisolone (2mg/kg/day), except for two cases with dexamethasone. The incidence of severe ICANS (grade ≥3) was 11.7%, comparable to real-world paediatric cohorts and lower than rates reported in adults treated with CD28-based constructs. Except for one case, severe ICANS did not occur with ARI-0001, suggesting a lower neurotoxicity profile compared with tisa-cel. Neurotoxicity resolved without sequelae in all but one patient."

Clinical • CNS Disorders • Epilepsy • Hematological Disorders • Movement Disorders • Pediatrics

LATE TOXICITIES AND QUALITY OF LIFE AFTER VARNIMCABTAGENE AUTOLEUCEL (VAR-CEL): THE ROLE OF ADVANCED PRACTICE NURSING (EBMT 2026) - "Adult long-term survivors treated with var-cel generally maintain functional status and psychosocial resilience. However, fatigue, sleep disturbances, sexual/fertility issues, and immune vulnerability remain prevalent, alongside moderate financial stress. These findings underscore the importance of APNCART in designing and implementing structured survivorship programs."

HEOR • Metastases • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • CNS Disorders • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Inflammation • Leukemia • Sleep Disorder

LATE TOXICITIES AND QUALITY OF LIFE AFTER VARNIMCABTAGENE AUTOLEUCEL (VAR-CEL): THE ROLE OF ADVANCED PRACTICE NURSING (EBMT 2026) - "Adult long-term survivors treated with var-cel generally maintain functional status and psychosocial resilience. However, fatigue, sleep disturbances, sexual/fertility issues, and immune vulnerability remain prevalent, alongside moderate financial stress. These findings underscore the importance of APNCART in designing and implementing structured survivorship programs."

HEOR • Metastases • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • CNS Disorders • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Inflammation • Leukemia • Sleep Disorder

FRAILTY ASSESSMENT AND THEIR PROGNOSTIC SIGNIFICANCE IN CAR T-CELL THERAPY. RESULTS FROM A PROSPECTIVE AND LONGITUDINAL SINGLE-CENTER STUDY (EBMT 2026) - " All patients with lymphoproliferative disorders (LPD) or acute lymphoblastic leukemia (ALL) eligible for commercial (axicabtagene autoleucel) or academic (ARI0001) CD19 CAR T-cell therapy were prospectively included after providing informed consent. Frailty was prevalent and dynamic among CAR T-cell candidates. Frailty was associated with poorer QoL and inferior survival. These findings suggest that routine frailty assessment and consideration of interventions to address frailty prior to CAR T-cell therapy may be beneficial in this group of patients."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • Geriatric Disorders • Hematological Malignancies • Leukemia • Mood Disorders

IMMUNE EFFECTOR CELL ASSOCIATED NEUROTOXICITY (ICANS) IN PAEDIATRIC PATIENTS FOLLOWING CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPY: EXPERIENCE FROM A TERTIARY CARE CENTER (EBMT 2026) - "ICANS treatment included intravenous anakinra 10mg/kg/8hours (16/24; 67%), siltuximab (9/24; 38%), and corticosteroids (10/24; 42%), mainly methylprednisolone (2mg/kg/day), except for two cases with dexamethasone. The incidence of severe ICANS (grade ≥3) was 11.7%, comparable to real-world paediatric cohorts and lower than rates reported in adults treated with CD28-based constructs. Except for one case, severe ICANS did not occur with ARI-0001, suggesting a lower neurotoxicity profile compared with tisa-cel. Neurotoxicity resolved without sequelae in all but one patient."

Clinical • CNS Disorders • Epilepsy • Hematological Disorders • Movement Disorders • Pediatrics

LATE TOXICITIES AND QUALITY OF LIFE AFTER VARNIMCABTAGENE AUTOLEUCEL (VAR-CEL): THE ROLE OF ADVANCED PRACTICE NURSING (EBMT 2026) - "Adult long-term survivors treated with var-cel generally maintain functional status and psychosocial resilience. However, fatigue, sleep disturbances, sexual/fertility issues, and immune vulnerability remain prevalent, alongside moderate financial stress. These findings underscore the importance of APNCART in designing and implementing structured survivorship programs."

HEOR • Metastases • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • CNS Disorders • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Inflammation • Leukemia • Sleep Disorder

CART19-BE-02: Study of the Infusion of ARI-0001 Cells in Patients With CD19 + Acute Lymphoid Leukemia Resistant or Refractory to Therapy (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Sara V. Latorre | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Multicenter Trial of Varnimcabtagene Autoleucel (VAR-CEL) For Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (CART19-BE-02 Trial) (EHA-EBMT-CART 2026) - No abstract available

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia

Varnimcabtagene Autoleucel (ARI-0001) in Patients with Relapsed or Refractory Mantle Cell Lymphoma: A Multicenter, Retrospective Study (EHA-EBMT-CART 2026) - "Tocilizumab was employed in 44% of patients, and 15% received corticosteroids as well. Patient characteristics Figure 1. Conclusions : Var-cel administration in a multicenter network of academic centers demonstrated efficacy in patients with R/R MCL, with a remarkably favorable safety profile."

Retrospective data • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Thrombocytopenia

A Multicenter Trial of Varnimcabtagene Autoleucel (VAR-CEL) For Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (CART19-BE-02 Trial) (EHA-EBMT-CART 2026) - No abstract available

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia

ACITAC-001: This Clinical Trial is a Single-arm, Non-randomized Pilot Trial to Determine the Safety of Administering Autologous Anti-C19 Cells (ARI-0001) and the Feasibility of Local CAR-T Cell Production in Patients Over 18 Years of Age With Relapsed/Refractory (R/R) CD19+ Hematologic Malignancies, Including R (clinicaltrials.gov) - P=N/A | N=12 | Not yet recruiting | Sponsor: GUSTAVO SALGUERO

New trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2

CAR-T ARI-0001 shows high response rates in adult patients with acute lymphoblastic leukemia (Clínic Barcelona) - "Results show this approach achieved deep responses in patients with few treatment options. 84% achieved complete remission with undetectable measurable residual disease (MRD) at day 28, rising to 87% complete remission within three months. 12-month overall survival was 80%, significant for this disease...Regarding safety, cytokine release syndrome—a common CAR-T side effect—occurred in 73% of patients, but only 12% had severe cases."

P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia

Real-world experience with varnimcabtagene autoleucel (murine CD19 CAR-T) from India: A step towards enhanced patient access with excellent safety and efficacy (ASH 2025) - "Tocilizumab, steroids and anakinra usage was in 39%, 9% and 4% respectively. The real-world experience provides strong evidence of efficacy and safety of varnim-cel in B-NHL comparable with pivotal study. It also proves the robustness of trans-national ultracold chainlogistics, safe and effective clinical delivery and management systems for commercial rollout acrossmultiple centres in India to provide equitable access in South Asia."

Preclinical • Real-world • Real-world evidence • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • CNS Disorders • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Primary Mediastinal Large B-Cell Lymphoma • Thrombocytopenia

Expanding the boundaries of CAR T-cell therapy: Implementation of an outpatient-at-home (OATH) model (ASH 2025) - "Eligible patients (pts) were adults with R/R B-cell precursor acute lymphoblastic leukemia (BCP-ALL) or multiple myeloma (MM) who met predefinedclinical criteria (ECOG 0–1, no active infections, availability of a trained caregiver, and low tumor burden).Pts and caregivers received pre-enrolment education, providing symptom detection tools, including thecaregiver-performed immune effector cell encephalopathy (ICE) score and an adverse event action plan.The protocol included AH lymphodepletion with fludarabine (30 mg/m²/d) and cyclophosphamide (300mg/m²/d) for three days, followed by fractionated infusions (10%, 30%, and 60%) of one of the academicCAR-T CD19-directed (varnimcabtagene autoleucel, ARI0001, 1x10⁶ CAR T cells/kg) or BCMA-directed(cesnicabtagene autoleucel, ARI0002h, 3x10⁶ CAR T cells/kg), depending on the underlying malignancy.Infusions were administered in a day care unit, with AH follow-up post-infusion.Pts were monitored via twice-daily telephone..."

CAR T-Cell Therapy • Clinical • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • CNS Disorders • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Multiple Myeloma

Varnimcabtagene autoleucel in relapsed / refractory B-cell malignancies: Manufacturing experience from India (ASH 2025) - "Scheduling, delivery logistics, maintenance of ultracold chain logistics and closecollaboration with clinical sites are important for effective delivery of CAR-T cell therapy products andoptimizing outcomes. Varnim-cel has shown robust performance in clinical trials and sustained success incommercial manufacturing. This report reveals consistent success with manufacturing varnim-cel forpatients in areas of high unmet need enabling efficient clinical implementation."

Hematological Malignancies • Oncology • CD4 • CD8