Clinical trial · Interventional
SCTB35 and SCTB41 With or Without Chemotherapy in Non-Hodgkin Lymphoma
A Phase Ib/II Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of SCTB35 in Combination With SCTB41, With or Without Concomitant Chemotherapy, in Patients With Non-Hodgkin's Lymphoma.
NCT07819188CI-TRIAL-00126301not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NHL - Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCTB35 injection | Drug | — | UNRESOLVED |
| SCTB41 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SCTB35 Plus SCTB41
- interventionNames
- Drug: SCTB35 injection
- Drug: SCTB41
Primary outcomes (2)
- measure
- Phase 1: dose limited toxicity (DLT)
- timeFrame
- Within 28 days of the first administration
- description
- To determine the maximum tolerated dose (MTD) and/or RP2D to be studied in the dose-expansion part
- measure
- Phase 2: Percentage of Participants Achieving Objective Response Rate (ORR)
- timeFrame
- Up to approximately 3 years
- description
- ORR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.