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Tests treatment safety and results for Non-Hodgkin's Lymphoma
Official title A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL
ClinicalTrials.gov ID: NCT05806099
What this study is testing
What is MBS303?
MBS303 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-hodgkin's lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel T-Cell bispecific (TCB), MBS303, administered by intravenous (IV) infusion in participants with relapsed or refractory B-cell NHL. This entry-to-human study consists of 2 parts: a dose escalation part (Phase I) and an expansion part (Phase Ⅱ)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able and willing to provide written informed consent and to comply with the study protocol.
- Adult patients, ≥18 years of age;
- CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to at least one prior treatment regimen with an anti-CD20 monoclonal...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy ≥3 months;
You likely can't join if
- Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;
- History of central nervous system (CNS) lymphoma or other CNS disease;
- Participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal...
- Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the...
- Active or suspected autoimmune diseases;
- Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
See the full eligibility criteria
- Able and willing to provide written informed consent and to comply with the study protocol.
- Adult patients, ≥18 years of age;
- CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to at least one prior treatment regimen with an anti-CD20 monoclonal antibody and for whom there is no available therapy expected to improve...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy ≥3 months;
- Measurable disease, defined as at lease one bi-dimensionally measurable nodal lesion, defined as \>1.5 cm in its longest dimension, or at least one bi-dimensionally measureable extranodal lesion, defined as \>1.0 cm in...
- Adequate hematologic, hepatic, and renal function.
- Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;
- History of central nervous system (CNS) lymphoma or other CNS disease;
- Participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal infections);
- Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the first MBS303;
- Active or suspected autoimmune diseases;
- Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
- Evidence of significant, uncontrolled concomitant disease;
- Major surgery within 28 days prior to the first MBS303 administration or expected to undergo major surgery during the study treatment;
- History of another invasive malignant tumors in past 3 years;
- Participant with history of confirmed progressive multifocal leukoencephalopathy (PML);
- Severe hemorrhagic diseases such as hemophilia A, hemophilia B, vascular hemophilia, or spontaneous bleeding requiring blood transfusion or other medical intervention;
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal HBV DNA or HCV RNA);
- Pregnant or lactating women; Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.