SCTB35 injection: SCTB35 will be subcutaneously administered at a dose as specified
SCTB41: SCTB41 will be IV administered at a dose as specified
Study summary
The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of SCTB35 and SCTB41 With or Without Chemotherapy in non-Hodgkin's lymphoma patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Aged 18 to 80 years (inclusive) at the time of informed consent
* Histologically or cytologically confirmed B cell neoplasm.
* Phase 1: Relapsed or refractory disease after at least two prior systemic therapy.
* Measurable or evaluable disease at enrollment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Adequate organ and bone marrow function
* Life expectancy of ≥ 3 months
Exclusion Criteria:
* Prior treatment with bispecific antibodies targeting both CD20 and CD3
* Prior treatment with antibodies targeting both PD-1/PD-L1, PD-(L)1/VEGF(R) or PD-(L)1/TGF-β
* Eligible for high dose chemotherapy followed by hematopoietic stem cell transplantation (HSCT)
* Known central nervous system (CNS) involvement by lymphoma
* Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks
* Chemotherapy and other non-investigational antineoplastic agents within 4 weeks or 5 half-lives (whichever is shorter) prior to first SCTB35 administration
Primary outcome measure(s)
Phase 1: dose limited toxicity (DLT) — Within 28 days of the first administration To determine the maximum tolerated dose (MTD) and/or RP2D to be studied in the dose-expansion part
Phase 2: Percentage of Participants Achieving Objective Response Rate (ORR) — Up to approximately 3 years ORR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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