A First-in-human Study of SCTB35 in Patients With Relapse/Refractory B-cell Non-Hodgkin Lymphoma

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinocelltech Ltd.

About this trial

This is a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics, and preliminary efficacy of SCTB35 monotherapy, an bispecific antibody, in patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Histologically or cytologically confirmed CD20+ mature B-cell neoplasm

De novo or transformed diffuse large B-cell lymphoma (DLBCL)

High-grade B-cell lymphoma (HGBCL)

Disqualifiers

Any prior therapy with an bispecific antibody of the same class

Eligible for high dose chemotherapy with hematopoietic stem cell transplantation (HSCT)

Known central nervous system (CNS) involvement by lymphoma

Cervical carcinoma of Stage Ib or less

Trial design

Treatments tested in this trial

  • SCTB35 injection

Treatment groups

76 Participants
are divided into 1 treatment group

Sponsors and collaborators