Prospective, international, non-interventional study to assess the short- and long-term safety and effectiveness of adult patients with relapsed or refractory B cell acute lymphoblastic leukemia receiving Aucatzyl® treatment (AUTO1-LT2)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001004
• Study ID:
  1000001004
• Official title and acronym:
  Prospective, international, non-interventional study to assess the short- and long-term safety and effectiveness of adult patients with relapsed or refractory B cell acute lymphoblastic leukemia receiving Aucatzyl® treatment (AUTO1-LT2)
• DARWIN EU® study:
  No
• Study countries:
  European Union

  United States
• Study description:
  This is a prospective international, non-interventional study to evaluate the safety (including secondary malignancies) and effectiveness of adult patients with r/r B ALL receiving Aucatzyl treatment in the post marketing setting.; The purpose of this study is to characterize the short- and long-term safety profile of Aucatzyl® (obecabtagene autoleucel; obe-cel) in the post-marketing setting, including the important identified risks and potential risks associated with this product. Aucatzyl is a cell-based therapy product consisting of autologous enriched T cells that are transduced with a lentiviral vector to express an anti-CD19 (CAT) CAR. This study will make secondary use of data collected from patients included in the EBMT and the CIBMTR cellular therapy registries.;
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Planned:30/07/2025

Actual:18/11/2025

Study start date

Planned:30/07/2025

Date of final study report

Planned:30/06/2045

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Autolus Limited

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  EMEA/H/C/005907/0000