NHL - Non-Hodgkin's Lymphoma
Conditions
Brief 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.
Interventions
DRUGSCTB35 injection
SCTB35 will be subcutaneously administered at a dose as specified
DRUGSCTB41
SCTB41 will be IV administered at a dose as specified
Sponsors
Sinocelltech Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 3 years | Overall survival is defined as the time from randomization to death from any cause. |
| Progression free survival (PFS) | Up to approximately 3 years | Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first. |
| Percentage of Participants Achieving CR | Up to approximately 3 years | Percentage of participants who achieve a CR determined per Lugano criteria. |
| Duration of Response (DOR) | Up to approximately 3 years | DOR is defined as the time from the first documented response (CR or PR) to disease progression or death, whichever occurs first. |
| Duration of Complete Response (DOCR) | Up to approximately 3 years | DOCR is defined as the time from the first documented CR to disease progression or death, whichever occurs first. |
| Time to Response (TTR) | Up to approximately 3 years | Time to response (TTR) is defined as the time from the start of therapy to the first documented CR or PR in patients who achieve an objective response |
| Time to Complete Response (TTCR) | Up to approximately 3 years | TTCR is defined as the time from the start of therapy to the first documented CR among patients with a complete response. |
| Adverse Events | Up to approximately 3 years | Treatment-emergent adverse events/serious adverse events/adverse events of special interest |
| Blood Concentrations of SCTB35 and SCTB41 | Up to approximately 6 months | Pharmacokinetics of SCTB35 and SCTB41 will be assessed using drug concentrations measured in plasma (or serum) at specified time points. |
| Anti-drug Antibodies of SCTB35 and SCTB41 | Up to approximately 3 years | Serum (or plasma) samples will be tested for the presence of anti-drug antibodies (ADAs) against SCTB35 and SCTB41 |
Countries
China
Outcome results
None listed