A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL
Condition(s) studied
Investigational drug(s) / intervention(s)
MBS303: Phase I: The patients confirming to the eligibility criteria will be assigned to one of the 7 dose groups (0.05/0.15/0.45 mg \~ 1.5/6/60 mg, respectively) based on the sequence of inclusion. Each patient will receive MBS303 as per the schedule specified in the respective arms. Based on the safety data of the previous dose groups, if pretreatment with MIL62 is required after disussion by the sponsor and the investigators, the subject should be given an IV infusion of MIL62 1000 mg single dose on the D-7. Phase Ⅱ: One or two recommended doses will be selected based on the results of Phase I. Each patient will receive one of the two recommended doses MBS303 as step-up doses on D1 (low dose) and D8 (intermediate dose) of C1 and at the target dose on D1 of C2-17 (21-day cycles). Based on the previous safety data, if pretreatment with MIL62 is required after disussion by the sponsor and the investigators, the subjects should be given an IV infusion of MIL62 1000 mg single dose on the D-7
Study summary
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)
Eligibility
Primary outcome measure(s)
- Phase I:Percentage of Participants with Adverse Events (AEs) — From Baseline up to approximately 13 months
Percentage of Participants with AEs and SAEs Assessed by NCI CTCAE v5.0 - Phase I:Incidence of Dose Limiting Toxicities (DLTs) — From Baseline up to 3 weeks
- Phase I:Maximum Tolerated Dose (MTD) of MBS303 — From Baseline up to 3 weeks
- Phase I:Recommended Phase Ⅱ Dose (RP2D) of MBS303 — From Baseline up to 4 years
- Phase Ⅱ :Antitumor activity as measured by the objective response rate (ORR) — Up to approximately 2 years
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China | Recruiting |
More Beijing Mabworks Biotech Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05806099 on ClinicalTrials.gov ↗ ← All trials in China