Real-world evidence of toxicity profile with cellular immunotherapy from India: Cellular insights study.

Abstract

e14533 Background: Real-world data on adverse events (AEs) following adoptive cellular immunotherapy in India is scarce. This study evaluates the toxicity spectrum among patients at SunAct Cancer Centre, focusing on Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)—the most critical complications. The analysis includes CAR-T (Chimeric Antigen Receptor T-cell), Gamma Delta T-cell, and TCR (T-cell Receptor) therapies. Methods: The Cellular Insights study, IEC-approved, prospectively collected data from June to December 2024 after informed consent. Adult patients (ECOG PS 0–2) were included. AEs were recorded from Day 1 of lymphodepletion or cell infusion (whichever applied) up to Day 30, classified per CTCAE v5.0, covering hematologic, gastrointestinal, and immune-mediated toxicities. Results: A total of 42 infusions were administered. Median patient age: 49 years (IQR 15–68). Female predominance: 57.1% female, 42.9% male. Patients had metastatic cancers, including rhabdomyosarcoma, ovarian, lung, and colorectal carcinoma. Cell doses: 3.2×10⁶ to 200×10⁶ cells/kg. All received pre-medications to mitigate toxicities: Avil (2cc IV slow push) for CRS/allergic reactions, Paracetamol (1g IV STAT) for fever/chills, and Ondansetron (8mg IV STAT) for nausea prevention.CRS occurred in 57.1% of patients, mainly Grade 1–2 (38.1%), with Grade 3 at 19.0%. ICANS was observed in 11.9%, with Grade 3 limited to 2.4%. Other common toxicities: nausea (38.1%), myalgia (33.3%), fatigue (33.3%), respiratory distress (33.3%). Hematologic AEs like anemia, neutropenia, thrombocytopenia were also recorded. The table details toxicity grading. Conclusions: This first real-world study from India confirms that CRS and ICANS rates align with global standards, aiding in refining patient management and optimizing treatment strategies. Incidence and severity of adverse events in patients undergoing cellular immunotherapy. Toxicity Type Grade 1 Grade 2 Grade 3 Grade 4 Total CRS 4 (9.5%) 12 (28.6%) 8 (19.0%) 0 (0.0%) 24 (57.1%) ICANS 2 (4.8%) 2 (4.8%) 1 (2.4%) 0 (0.0%) 5 (11.9%) Myalgia 10 (23.8%) 4 (9.5%) 0 (0.0%) 0 (0.0%) 14 (33.3%) Fatigue 10 (23.8%) 4 (9.5%) 0 (0.0%) 0 (0.0%) 14 (33.3%) Nausea 12 (28.6%) 4 (9.5%) 0 (0.0%) 0 (0.0%) 16 (38.1%) Headaches 8 (19.0%) 2 (4.8%) 0 (0.0%) 0 (0.0%) 10 (23.8%) GI Symptoms* 12 (28.6%) 4 (9.5%) 0 (0.0%) 0 (0.0%) 16 (38.1%) Hypokalemia 8 (19.0%) 2 (4.8%) 0 (0.0%) 0 (0.0%) 10 (23.8%) Arrhythmia 1 (2.4%) 1 (2.4%) 0 (0.0%) 0 (0.0%) 2 (4.8%) Respiratory Distress 10 (23.8%) 4 (9.5%) 0 (0.0%) 0 (0.0%) 14 (33.3%) Infections (Fungal Mucositis) 12 (28.6%) 4 (9.5%) 0 (0.0%) 0 (0.0%) 16 (38.1%) *GI symptoms included vomiting, diarrhea, constipation, abdominal pain etc.