*Pegathor Lymphoma 205

• Research type

  Research Study

• Full title

  Phase 2 non-randomized, open-label, multi-cohort, multicenter study assessing the clinical benefit of SAR444245 (THOR-707) with or without other anticancer therapies for the treatment of adults and adolescents with relapsed or refractory B cell lymphoma (Pegathor Lymphoma 205)

• IRAS ID

  1004190

• Contact name

  NA NA

• Contact email

  uk-medicalinformation@sanofi.com

• Sponsor organisation

  Sanofi-Aventis Recherche & Développement

• Eudract number

  2021-002150-91

• Clinicaltrials.gov Identifier

  NCT05179603

• Research summary

  This trial is for adults and adolescents with relapsed or refractory B cell lymphoma.

  This study is structured as a master protocol with separate sub studies designed to investigate the use of SAR444245 either with or without other anticancer therapies for the treatment of relapsed or refractory B cell lymphoma.

  The trial aims to determine the antitumor activity of SAR444245 (THOR 707) for the treatment of relapsed or refractory B cell lymphoma when it is given along with or without other anticancer therapies.
  Sub study 01 will look at the safety of the study drug when taken with another drug, pembrolizumab, and assess how it prevents or inhibits the formation or growth of in patients who have classic Hodgkin lymphoma (cHL).
  Sub study 03 will look at the safety of the study drug and assess how it prevents or inhibits the formation or growth of in patients who have diffuse large B-cell lymphoma (DLBCL).

  The duration of the study for an individual patient will start from the signature of the main informed consent and include:
  • a screening period of up to 28 days
  • a treatment period [max 35-52 cycles or until disease progression]
  • an end-of-treatment visit at least approximately 30 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier)
  • and a follow-up visits 3 months after treatment discontinuation and every 3 months thereafter following, until disease progression, or initiation of another antitumor treatment, or death, whichever is earlier

  The study Sponsor is Sanofi and will be recruiting in approximately 10 countries globally and the study completion date is approximately 16 September 2025.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  22/EM/0180

• Date of REC Opinion

  11 Jul 2022

• REC opinion

  Further Information Favourable Opinion