Varnimcabtagene autoleucel in relapsed or refractory B-cell malignancies

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Varnimcabtagene autoleucel (varnim-cel), an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy, has demonstrated an antitumor activity and toxicity profile consistent with known CAR T-cell–associated adverse effects in patients with relapsed or refractory B-cell malignancies, including B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL). In this phase 2 clinical trial, we evaluated the efficacy and safety of varnim-cel in individuals with relapsed or refractory B-cell malignancies with at least 1 prior line of therapy. Varnim-cel was administered at a dosage range of 0.1 × 10 6 to 5 × 10 6 CAR + T cells per kg. Primary end points were safety and overall response rate (ORR), defined as complete remission (CR) or CR with incomplete hematologic recovery for B-ALL and CR or partial response for B-NHL. Of the 24 patients treated with varnim-cel, day +28 ORR was 92% (22 of 24 patients). Twenty of 24 patients (ORR, 83%) demonstrated a clinical response at day +90 (primary end point). At a median follow-up of 10.6 months, 10 of the 24 patients (42%) maintained a response. Median progression-free survival was 8.9 months. Common treatment-emergent adverse events were cytopenias (neutropenia, 100%; anemia, 96%; and thrombocytopenia, 92%), cytokine release syndrome in 16 patients (67%), including 1 case (4%) of grade ≥3 severity and 1 patient (4%) with grade 1 immune effector cell–associated neurotoxicity syndrome, with no cases of grade ≥3. Varnim-cel induced durable responses in relapsed or refractory B-cell malignancies, with a favorable safety profile and low incidence of severe immune-mediated adverse events. This trial was registered at www.ctri.nic.in as CTRI/2022/03/041162.

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