A multi-center study published in Haematologica (December 2025) evaluated the success rate and clinical outcomes of locally manufactured CAR-T therapy compared with established commercial CAR-T products in patients with large B-cell lymphoma (LBCL) who had failed at least two prior lines of treatment.

Study Design and Participating Centers

  • Study type: Retrospective, multi-center propensity score–matched analysis
  • Total patients: 330
  • Participating academic medical centers:
    Chaim Sheba Medical Center (Tel HaShomer, Israel)
    Rambam Health Care Campus (Haifa, Israel)
    Memorial Sloan Kettering Cancer Center (New York, USA)

Patients receiving locally manufactured CAR-T therapy were treated at Sheba Medical Center, while commercial CAR-T products were administered at all three centers.

CAR-T Therapy Success Rate and Effectiveness

Progression-Free Survival (PFS):

  • Locally manufactured CAR-T therapy demonstrated a trend toward improved progression-free survival compared with axicabtagene ciloleucel
  • No significant difference in PFS was observed between locally manufactured CAR-T and tisagenlecleucel

Overall Survival (OS):

  • Overall survival rates were comparable across all treatment groups
  • No statistically significant difference in survival between locally manufactured and commercial CAR-T therapies

Key conclusion:

Locally manufactured CAR-T therapy achieved success rates comparable to leading commercial CAR-T products, even in patients with aggressive or refractory disease.

Speed of Treatment: A Key Advantage

One of the most clinically relevant findings was the significantly shorter time from cell collection to infusion:

  • Locally manufactured CAR-T: 11 days
  • Axicabtagene ciloleucel: 38 days
  • Tisagenlecleucel: 44 days

This rapid availability is particularly important for patients with fast-progressing lymphoma, where treatment delays can negatively impact outcomes.

Safety Profile

  • Lower rates of moderate-to-severe cytokine release syndrome (grade ≥2) were observed with locally manufactured CAR-T therapy
  • Overall safety outcomes were comparable or favorable relative to commercial CAR-T products

Relevance for International Patients

This study highlights why locally manufactured CAR-T therapy in leading academic centers may offer meaningful advantages for international patients:

  • Comparable success rates and survival outcomes
  • Much faster access to treatment
  • Reduced dependency on international manufacturing and shipping
  • Treatment delivered at globally recognized cancer centers

Conclusion

The findings support locally manufactured CAR-T therapy as a clinically effective and reliable alternative to commercial CAR-T products for large B-cell lymphoma. With similar success rates, comparable survival, improved safety signals, and significantly faster availability, local CAR-T manufacturing represents an important advancement in personalized cancer care.


Treating Physicians and Investigators: Ronit Marcus, Abraham Avigdor, Uri Greenbaum, Samantha Brown, Shalev Fried, Noa Golan-Accav, Noga Shem-Tov, Ronit Yerushalmi, Ivetta Danylesko, Elad Jacoby, Arnon Nagler, Avichai Shimoni, Orit Itzhaki, Jonathan Esensten, Ori Ben Valid, Annamaria Ballweg, Xavier Deschênes-Simard, Efrat Luttwak, Gunjan Shah, Michael Scordo, Parastoo Dahi, Miguel-Angel Perales, Tsila Zuckerman, Sean M. Devlin, Dana Yehudai-Ofir, Hazim Khatib, Nivin Shibly, Roni Shouval, Ofrat Beyar-Katz


Publication date: Dec 28, 2025.
Source: haematologica.org