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Phase I Clinical Study of JS203 in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05618327
Recruitment Status : Not yet recruiting
First Posted : November 16, 2022
Last Update Posted : November 16, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma Drug: JS203 for Injection Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 219 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Study of JS203 in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Estimated Study Start Date : November 22, 2022
Estimated Primary Completion Date : December 24, 2024
Estimated Study Completion Date : February 22, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: JS203 Drug: JS203 for Injection

2-steps:JS203 for Injection is administered on the first and eighth day of the first cycle and every 3 weeks thereafter.

3-steps:JS203 for Injection is administered on the first, eighth and fifteenth day of the first cycle and every 3 weeks thereafter.

4-steps:JS203 for Injection is administered on the first, eighth, fifteenth and twenty-second day of the first cycle and every 3 weeks thereafter.





Primary Outcome Measures :
  1. 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.

  2. 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 .


Secondary Outcome Measures :
  1. DLT events [ Time Frame: Up to 2 years ]
    Incidence and severity of DLT events.

  2. Adverse events (AEs) [ Time Frame: Up to 2 years ]
    Incidence and severity of adverse events (AEs)

  3. Serious adverse events (SAEs) [ Time Frame: Up to 2 years ]
    Incidence and severity of serious adverse events (SAEs).

  4. abnormal changes in clinically significant laboratory tests and other examinations [ Time Frame: Up to 2 years ]
    abnormal changes in clinically significant laboratory tests and other examinations

  5. Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]
    Objective Response Rate (ORR) as Assessed by Investigator according to Lugano 2014

  6. Complete Response (CR) [ Time Frame: Up to 2 years ]
    Complete Response (CR) as Assessed by Investigator according to Lugano 2014

  7. Duration of Objective Response (DOR) [ Time Frame: Up to 2 years ]
    Duration of Objective Response (DOR) as Assessed by Investigator

  8. Duration of Complete Response (DOCR) [ Time Frame: Up to 2 years ]
    Duration of Complete Response (DOCR) as Assessed by Investigator

  9. Time to Response(TTR) [ Time Frame: Up to 2 years ]
    Time to Response(TTR) as Assessed by Investigator

  10. Progression-Free Survival (PFS) [ Time Frame: Up to 2 years ]
    Progression-Free Survival (PFS) as Determined by Investigator

  11. Overall Survival (OS) [ Time Frame: Up to 2 years ]
    Overall Survival (OS)

  12. Antidrug antibodies (ADA) and/or neutralizing antibodies (Nab) [ Time Frame: At pre-defined intervals up to 2 years ]
    incidence of antidrug antibodies (ADA) and/or neutralizing antibodies (Nab)

  13. Total exposure(AUC) of JS203 [ Time Frame: At pre-defined intervals up to 2 years ]
    Total exposure(AUC) of JS203

  14. Maximum Plasma Concentration (Cmax) of JS203 [ Time Frame: At pre-defined intervals up to 2 years ]
    Maximum Plasma Concentration (Cmax) of JS203

  15. Half-life(T1/2) of JS203 [ Time Frame: At pre-defined intervals up to 2 years ]
    Half-life(T1/2) of JS203

  16. Clearance(CL) of JS203 [ Time Frame: At pre-defined intervals up to 2 years ]
    Clearance(CL) of JS203

  17. Volume of Distribution (Vss) of JS203 [ Time Frame: At pre-defined intervals up to 2 years ]
    Volume of Distribution (Vss) of JS203

  18. Pharmacodynamic (PD) characteristics [ Time Frame: At pre-defined interval up to 2 years ]
    CD20 receptor occupancy rate in peripheral blood cells

  19. Pharmacodynamic (PD) characteristics [ Time Frame: At pre-defined interval up to 2 years ]
    Changes in peripheral blood immune cell subtypes (B cells, T cells) before and after drug administration.

  20. Pharmacodynamic (PD) characteristics [ Time Frame: At pre-defined interval up to 2 years ]
    Changes in peripheral blood cytokines (IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ) before and after drug administration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Understand and voluntarily sign the informed consent form.
  2. Age 18 - 75 years (both 18 and 75 years), both sexes
  3. Expected survival of ≥ 12 weeks.
  4. Eastern Collaborative Oncology Group (ECOG) physical status score: 0 to 1.
  5. B-cell non-Hodgkin's lymphoma expressing CD20 antigen clearly diagnosed by pathology
  6. 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:

  1. history of severe allergy or anaphylactic reaction to monoclonal antibody therapy (or recombinant antibody-associated fusion protein).
  2. previous treatment with CD20-CD3 bispecific antibodies.
  3. 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.
  4. 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).
  5. receive autologous hematopoietic stem cell transplantation within 100 days prior to the first dose
  6. 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
  7. 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.
  8. 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%.
  9. 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.
  10. persons with uncontrollable psychiatric disorders
  11. patients with a history of drug abuse or alcohol abuse
  12. other conditions judged by the investigator to be inappropriate for participation in this study, including but not limited to having any disease or medical history that may confound study results and interfere with patient compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05618327


Contacts
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Contact: Zhihao Jiang 86-15350403639 zhihao_jiang@junshipharma.com

Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Contact: Wanli Shen    86-010-88196393    gcp_shenwl@bjcancer.org   
Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.
Investigators
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Principal Investigator: Yuqin Song, MD Peking University Cancer Hospital & Institute
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Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT05618327    
Other Study ID Numbers: JS203-001-I
First Posted: November 16, 2022    Key Record Dates
Last Update Posted: November 16, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases