A Phase Ia/Ib Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SCTB35 in Patients With CD20+ Relapse/Refractory B-cell Non-Hodgkin Lymphoma
Overview
- Phase
- Phase 1
- Intervention
- SCTB35 injection
- Conditions
- Non-Hodgkin Lymphoma, B-cell
- Sponsor
- Sinocelltech Ltd.
- Enrollment
- 76
- Locations
- 3
- Primary Endpoint
- Dose-escalation part: dose limited toxicity (DLT)
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
This is the first-in-human study of SCTB35, containing the dose-escalation and dose-expansion parts. The escalation cohorts will be enrolled to explore the maximum tolerated dose and recommended phase II dose (RP2D). A Safety Monitoring Committee (SMC) will review the accumulated safety data and other available data, and make a recommendation to each dose level of SCTB35 in the escalation cohorts. The expansion cohorts will be initiated after the RP2D is confirmed, and to further compare the preliminary efficacy and safety of SCTB35 at two dose levels that appropriately recommended by SMC.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients are eligible to be included in the study only if all the following conditions are met:
- •Age ≥ 18 years
- •Histologically or cytologically confirmed CD20+ mature B-cell neoplasm
- •For dose-escalation phase:
- •De novo or transformed diffuse large B-cell lymphoma (DLBCL)
- •High-grade B-cell lymphoma (HGBCL)
- •Primary mediastinal large B-cell lymphoma (PMBCL)
- •Follicular lymphoma (FL)
- •Mantle cell lymphoma
- •Small lymphocytic lymphoma (SLL)
Exclusion Criteria
- •A patient who conforms to any of the following criteria should be excluded from the study:
- •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
- •Known past or current malignancy other than inclusion diagnosis, with the following exceptions:
- •Cervical carcinoma of Stage Ib or less
- •Non-invasive basal cell or squamous cell skin carcinoma
- •Non-invasive, superficial bladder cancer
- •Prostate cancer with a current prostate-specific antigen (PSA) level \<0.1 ng/mL
- •Any curable cancer with a complete response (CR) of \>2 years duration
Arms & Interventions
SCTB35
SCTB35 injection is subcutaneously given every week for the first 4 cycles, and thereafter every 3 weeks. Cycles will be repeated every 3 weeks until disease progression, study discontinuation, or death, whichever occurs first.
Intervention: SCTB35 injection
Outcomes
Primary Outcomes
Dose-escalation part: dose limited toxicity (DLT)
Time Frame: During the first cycle (21 days)
To determine the maximum tolerated dose (MTD) and/or RP2D to be studied in the dose-expansion part
Dose-escalation part: incidence rate of adverse event (AE)
Time Frame: From first dose until 28 days after last dose of study drug or until study completion or participant withdrawal (up to 3 years)
To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE), adverse event with special interest (AESI)
Dose-expansion part: objective response rate (ORR)
Time Frame: From first dose until up to 2 years
ORR is defined as the percentage of patients achieving complete response (CR) or partial response (PR) as determined by the investigator according to the Lugano Criteria 2014
Secondary Outcomes
- Dose-escalation part: best of overall response (BOR)(From first dose until up to 2 years)
- Dose-escalation part: ORR(From first dose until up to 2 years)
- Dose-escalation part: CR rate (CRR)(From first dose until up to 2 years)
- Dose-expansion part: OS(From first dose until up to 5 years)
- Dose-escalation part: overall survival (OS)(From first dose until up to 5 years)
- Dose-expansion part: BOR(From first dose until up to 2 years)
- Dose-escalation part: duration of response (DOR)(From first dose until up to 2 years)
- Dose-escalation part: time to response (TTR)(From first dose until up to 2 years)
- Dose-escalation part: blood concentrations of SCTB35(From first dose until up to 2 years)
- Dose-escalation part: anti-drug antibodies of SCTB35(From first dose until up to 2 years)
- Dose-expansion part: CRR(From first dose until up to 2 years)
- Dose-expansion part: DOR(From first dose until up to 2 years)
- Dose-expansion part: PFS(From first dose until up to 2 years)
- Dose-expansion part: TTR(From first dose until up to 2 years)
- Dose-escalation part: progression-free survival (PFS)(From first dose until up to 2 years)
- Dose-expansion part: AE(From first dose until up to 2 years)
- Dose-expansion part: blood concentrations of SCTB35(From first dose until up to 2 years)
- Dose-expansion part: anti-drug antibodies of SCTB35(From first dose until up to 2 years)