To identify predictive biomarkers, we performed flow cytometry and multiplex assays before and early after CAR-T infusion on 78 patients (ide-cel n = 31; axi-cel n = 24; and cilta-cel n = 23) undergoing CAR-T therapy. Baseline sIL-2R and sVCAM-1 demonstrated robust predictive value for prolonged neutropenia, severe infections, and mortality independently of key clinical variables such as the underlying disease and CAR-T product. Integration of these markers improves existing models and can help to refine risk assessment and guide individualized patient management in CAR-T therapy.

P2, N=210, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting

We analyze 61 RRMM patients receiving idecabtagene vicleucel (Ide-cel; n = 34) or ciltacabtagene autoleucel (Cilta-cel; n = 27) and find that Cilta-cel achieves higher complete response (CR) rates (78% vs. 38%) and longer progression-free survival. Greater reductions in soluble BCMA correlate with enhanced CAR T expansion and systemic inflammation. These findings reveal cellular mechanisms driving differential efficacy and toxicity of BCMA-directed immunotherapy.

Receiver operating characteristic curve analysis determined pretreatment hemoglobin (Hb) and C-reactive protein-to-albumin ratio (CAR) cut-offs of 11.0 g/dL and 3.0, respectively, which were utilized to create a three-tiered HCAR score: HCAR-0 (Hb ≥11.0 g/dL and CAR <3.0), HCAR-1 (Hb ≥11.0 g/dL and CAR ≥3.0 or Hb <11.0 g/dL and CAR <3.0), and HCAR-2 (Hb <11.0 g/dL and CAR ≥3.0)...Corresponding 10-year PFS rates were 50.2%, 34.4%, and 5.0%, while 10-year OS rates were 68.3%, 41.6%, and 11.1%. Multivariate analysis revealed that the HCAR score remained an independent predictor of both PFS and OS, alongside T and N stage. The HCAR score shows promising prognostic utility for predicting OS and PFS in LANPC; however, performance estimates may be overly optimistic due to the lack of internal validation.

P1, N=64, Recruiting, AstraZeneca | N=20 --> 64

P1, N=6, Recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Trial primary completion date: Aug 2025 --> Dec 2026

P1, N=9, Recruiting, Gracell Biotechnologies (Shanghai) Co., Ltd.

P2, N=6, Active, not recruiting, Cartesian Therapeutics | Recruiting --> Active, not recruiting | N=30 --> 6

Here, we present the characterization and interim Phase I data for P-BCMA-ALLO1, a TSCM-predominant allogeneic CAR-T therapy targeting BCMA in heavily pretreated relapsed/refractory multiple myeloma...These data suggest that a TSCM cellular phenotype may offer significant advantages in efficacy, safety, and cellular persistence in the context of allogeneic CAR-T therapy. Clinical trial: NCT04960579.

P1, N=4, Terminated, Cartesian Therapeutics | Trial completion date: Oct 2027 --> Nov 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2026 --> Apr 2025; Phase 1 enrollment completed. Further clinical development terminated

Finally, we characterize NINT associated CD4 + CAR T cell populations which are potential therapeutic targets for future exploration. Ciltacabtagene autoleucel associated non-ICANS neurotoxicities are driven by high CD4 + CAR T cell expansion exhibiting memory marker expression and upregulated inflammatory gene signaling pathways.

P1, N=27, Recruiting, University College, London | Active, not recruiting --> Recruiting | Trial completion date: Dec 2035 --> Mar 2029 | Trial primary completion date: Dec 2025 --> Mar 2029