Molecular profiling of tissue samples from patients who received a Kite-manufactured gene-modified cell therapy and have developed a secondary malignancy of T-cell origin

Study identification

• EU PAS number:
  EUPAS1000000769
• Study ID:
  1000000769
• Official title and acronym:
  Molecular profiling of tissue samples from patients who received a Kite-manufactured gene-modified cell therapy and have developed a secondary malignancy of T-cell origin
• DARWIN EU® study:
  No
• Study countries:
  European Union

  United Kingdom
• Study description:
  KT-EU-982-0910: This is an observational study of patients who received a Kite-manufactured chimeric antigen receptor (CAR) T-cell therapy (axicabtagene ciloleucel or brexucabtagene) and have reported a secondary malignancy of T-cell origin. ; ; The primary objective of this study is to assess potential chimeric antigen receptor (CAR) transgene involvement by performing molecular profiling of tissue and blood samples obtained or are about to be obtained during clinical evaluation, from patients who were treated with axicabtagene ciloleucel or brexucabtagene autoleucel and are suspected to have developed a secondary T-cell malignancy.
• Study status:
  Planned

Research institutions and networks

Institutions

Gilead Sciences

Kite, a Gilead Company

Study timelines

Date when funding contract was signed

Planned:08/11/2025

Study start date

Planned:08/10/2025

Date of final study report

Planned:10/01/2040

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)