At the European Society for Medical Oncology (ESMO) Congress, held in Berlin, Germany from 17 October to 21 October 2025, investigators presented data from the prospective, single-arm, single-centre Phase II trial (NCT06081478) evaluating Hebei Taihe Chunyu Biotechnology’s CAR2219, a novel bispecific CD19/CD22-directed CAR-T (chimeric antigen receptor T-cell) therapy for elapsed or refractory (R/R) large B-cell lymphoma (LBCL).
LBCL continues to present major clinical challenges despite improvements with chemoimmunotherapy. Approximately 40% of patients relapse or develop refractory disease (R/R) following first-line therapy, and outcomes remain suboptimal even with autologous stem cell transplant and CD19-directed CAR-T therapies. Antigen loss, particularly the down-regulation or deletion of CD19, has emerged as a critical driver of post-CAR-T resistance, prompting the development of multi-targeted and dual antigen approaches to overcome resistance to improve long-term disease control.
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The trial enrolled patients with CD19 and CD22-positive B-cell lymphoma who were R/R following standard-of-care first-line therapy. By simultaneously targeting CD19 and CD22, CAR2219 aims to mitigate antigen-loss-driven relapse and enhance response durability.
In the R/R LBCL cohort, a single infusion of CAR2219 following lymphodepletion yielded an overall response rate (ORR) of 100%, comprising a complete response rate (CRR) of 67.7% and partial response of 32.3% at a median follow-up of 4.2 months. Median progression-free survival (PFS) and overall survival (OS) were not yet reached with estimated six-month PFS rates of 83% and OS rates of 87.1%.
The safety profile was favourable, with predominantly grade 1 to grade 2 cytokine release syndrome observed in 74% of patients (input data, no grade 3 or greater events) and immune effector cell-associated neurotoxicity syndrome in only 6% (one grade 3 event). The most common haematological toxicities were neutropenia (93%) and thrombocytopenia (77%), consistent with existing CAR-T therapies.
If future multi-centre data confirms sustained remission in long-term follow up with manageable toxicity, CAR2219 will compete with approved products including Gilead and Kite’s Yescarta (axicabtagene ciloleucel), Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) and Novartis’s Kymriah (tisagenlecleucel) in later-line LBCL. Compared to T-cell engagers, such as AbbVie and Genmab’s Epkinly (epcoritamab) and Roche’s Lunsumio (mosunetuzumab) and Columvi (glofitamab), CAR2119’s single-infusion approach offers potential cost and compliance advantages, though these competitors maintain outpatient convenience and strong commercial momentum.
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By GlobalDataAccording to GlobalData’s analyst consensus forecast, global annual sales by 2031 are projected to reach $2.11 billion for Yescarta, $2.98 billion for Breyanzi and $305 million for Kymriah. Sustained long-term efficacy from CAR2219 may draw market share from these therapies but will have more of an impact on defining sequencing strategies for post-CD-19-directed CAR-T cell therapy. Though early and limited by single-centre design, CAR2219’s 100% ORR and favourable safety and tolerability profile signal a potential next-generation standard in dual-antigen CAR-T development, pressuring both existing CAR-Ts and long-term T-cell engager sales. Longer follow-up and scaleability data will determine whether it can transition from promising innovation to a commercially competitive therapy reshaping the R/R LBCL landscape.
