NCT05618327
Active, not recruiting
Phase 1
Phase I Clinical Study of JS203 in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Shanghai Junshi Bioscience Co., Ltd.1 site in 1 country104 target enrollmentStarted: February 13, 2023Last updated:
InterventionsJS203 for Injection
DrugsJS203 for Injection
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- RP2D
Overview
Brief Summary
This is an open phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity, and preliminary efficacy of JS203 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. The study is divided into three phases: a dose-escalation phase, a dose-expansion phase, and an efficacy expansion phase.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Understand and voluntarily sign the informed consent form.
- •Age 18 - 75 years (both 18 and 75 years), both sexes
- •Expected survival of ≥ 12 weeks.
- •Eastern Collaborative Oncology Group (ECOG) physical status score: 0 to
- •B-cell non-Hodgkin's lymphoma expressing CD20 antigen clearly diagnosed by pathology
- •Patients with non-Hodgkin's lymphoma must have measurable lesions that meet the Lugano 2014 criteria for lymphoma efficacy assessment, requiring lymph node lesions \>1.5 cm in either length or extra-nodal lesions \>1.0 cm in either length.
Exclusion Criteria
- •history of severe allergy or anaphylactic reaction to monoclonal antibody therapy (or recombinant antibody-associated fusion protein).
- •previous treatment with CD20-CD3 bispecific antibodies.
- •failure to resolve toxicity after prior antitumor therapy, i.e., no return to baseline or grade 0-1 as defined by NCI-CTCAE 5.0 (except for alopecia, hyperpigmentation). Irreversible toxicity that is not reasonably expected to be exacerbated by the study drug and may be enrolled upon confirmation with the sponsor.
- •Received antitumor therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or biologic therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose. Non-tumor related conditions that are amenable to hormone therapy (e.g. insulin therapy for diabetes and hormone replacement therapy).
- •receive autologous hematopoietic stem cell transplantation within 100 days prior to the first dose
- •have undergone, or are expected to require during the study period, major surgery (as judged by the investigator) or are recovering from surgery within 4 weeks prior to the first dose
- •active hepatitis B or C. Active hepatitis B defined as positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) with HBV DNA above the upper limit of the study center's normal value; active hepatitis C defined as positive for hepatitis C antibody and HCV RNA above the upper limit of the study center's normal value.
- •history of cardiac disease: New York Heart Association (NYHA) \> Class II congestive heart failure, myocardial infarction occurring within 6 months prior to enrollment, or arrhythmia requiring antiarrhythmic therapy and/or left ventricular ejection fraction \< 50%.
- •two or more malignancies within 5 years prior to the first dose. Except for early malignancies that have been eradicated (carcinoma in situ or stage I tumors), such as adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer.
- •persons with uncontrollable psychiatric disorders
Arms & Interventions
JS203
Experimental
Intervention: JS203 for Injection (Drug)
Outcomes
Primary Outcomes
RP2D
Time Frame: Throughout the dose escalation and dose expansion phases, an average of 1.5 years
It is suitable for dose escalation and dose extension.RP2D will be determined based on a combination of safety, tolerability, PK and/or pharmacodynamic studies .
MTD
Time Frame: Throughout the dose escalation and dose expansion phases,, an average of 1.5 years
It is suitable for dose escalation and dose extension.If the number of DLT patients is 0 and the next higher dose is unacceptable, the current dose is declared MTD.
Secondary Outcomes
- DLT events(Up to 2 years)
- Serious adverse events (SAEs)(Up to 2 years)
- Duration of Complete Response (DOCR)(Up to 2 years)
- Half-life(T1/2) of JS203(At pre-defined intervals up to 2 years)
- Adverse events (AEs)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Antidrug antibodies (ADA) and/or neutralizing antibodies (Nab)(At pre-defined intervals up to 2 years)
- Maximum Plasma Concentration (Cmax) of JS203(At pre-defined intervals up to 2 years)
- Complete Response (CR)(Up to 2 years)
- Time to Response(TTR)(Up to 2 years)
- Clearance(CL) of JS203(At pre-defined intervals up to 2 years)
- Volume of Distribution (Vss) of JS203(At pre-defined intervals up to 2 years)
- abnormal changes in clinically significant laboratory tests and other examinations(Up to 2 years)
- Progression-Free Survival (PFS)(Up to 2 years)
- Total exposure(AUC) of JS203(At pre-defined intervals up to 2 years)
- Pharmacodynamic (PD) characteristics(At pre-defined interval up to 2 years)
- Objective Response Rate (ORR)(Up to 2 years)
- Duration of Objective Response (DOR)(Up to 2 years)
Investigators
Study Sites (1)
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