OncoMatch/Clinical Trials/NCT06392477

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

Is NCT06392477 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies SAR448501 for b-cell non hodgkin lymphoma.

Phase 1RecruitingSanofiNCT06392477Data as of May 2026

Treatment: SAR448501 — 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 of every 3 months until withdrawal of consent, participant death or study closure, whichever is sooner.

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Extracted eligibility criteria

Cancer type

Hodgkin Lymphoma

Non-Hodgkin Lymphoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Cannot have received: allogeneic stem cell transplantation

Exception: Follicular lymphoma (FL) and mantle cell lymphoma (MCL) excluded if transplant <100 days prior to dosing or if grade >1 graft versus host disease

Prior allogeneic stem cell transplantation except for those with follicular lymphoma (FL) and mantle cell lymphoma (MCL), who are excluded if transplant occurred less than 100 days prior to dosing or if they exhibit grade > 1 graft versus host disease.

Cannot have received: autologous stem cell transplantation

Exception: Allowed if >100 days prior to dosing

Autologous stem cell transplantation 100 days prior to dosing.

Cannot have received: solid organ transplantation

Prior solid organ transplantation.

Lab requirements

Blood counts

adequate marrow reserve

Kidney function

adequate renal function

Liver function

adequate hepatic function

Adequate marrow reserve, renal function, and hepatic function.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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