A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Relapsed/ Refractory B-Cell Non-Hodgkin Lymphoma

This is an open-label, multiple ascending dose (MAD), phase 1 study in adult patients with relapsed or refractory (R/R) B cell non-Hodgkin lymphoma (B-NHL). The purpose of the study is to identify possible optimal biological dosage(s) by assessing safety, tolerability, pharmacokinetics (PK), pharmacodynamics, clinical activity and immunogenicity of SAR448501/DR-0201. The study duration per participant will be approximately 3 years, including a screening period of up to 28 days, a treatment period of 52 weeks, a safety follow-up period of approximately 28 days and a long-term follow-up period

Trial Details

NCT ID
NCT06392477
Phase
PHASE1
Sponsor
Sanofi
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • SAR448501
Locations (sample)
  • Camperdown, New South Wales, Australia|-33.88965,151.17642
  • Townsville, Queensland, Australia|-19.26639,146.80569
  • Adelaide, South Australia, Australia|-34.92866,138.59863
  • Melbourne, Victoria, Australia|-37.814,144.96332
  • Perth, Western Australia, Australia|-31.95224,115.8614

Key Eligibility Criteria

  • Participants with R/R B-NHL which has failed at least 2 prior lines available life-prolonging standard therapy and without treatment options that a…
  • Adequate marrow reserve, renal function, and hepatic function.
  • Measurable disease defined as ≥ 1 bi-dimensionally measurable nodal lesion of \> 1.5 cm in the longest dimension for participants with fluorodeoxyg…
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

For full eligibility, visit ClinicalTrials.gov.

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