A Clinical Study of 6MW3211 Injection in the Treatment of Relapsed/Refractory Lymphoma

Phase 2

Not yet recruiting

• Conditions: Lymphoma
• Interventions: Drug: 6MW3211

• Registration Number: NCT05446688
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Brief Summary

This study is a single arm, non-randomized, open label phase 2 international, multicenter clinical trial to evaluate preliminary efficacy and safety in subjects with relapsed or refractory lymphoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-27
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-02
• Last Update Submitted: 2022-07-02
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-07
• Study Start: 2022-09-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Voluntarily participate in the study and sign the informed consent.
• Age≥18 years.
• Subjects with relapsed or refractory lymphoma.
• Subjects with at least one measurable tumor lesion.
• ECOG 0-2.
• Life expectancy≥3 months.
• Adequate organ functions.

Exclusion Criteria

• Subjects who had received anticancer therapy or radiotherapy within 21 days or 5 half-lives (whichever is shorter) before enrollment or received adoptive cellular immunotherapy within 12 weeks.
• Subjects who had received allogeneic hematopoietic stem cell transplantation or organ transplantation or received autologous hematopoietic stem cell transplantation within 3 months.
• Subjects with primary or secondary CNS lymphoma.
• History of another malignancy within 3 years before the first dose of investigational drug.
• History of active autoimmune diseases.
• Systemic immunosuppressive therapy within 2 weeks prior to the first dose of investigational drug.
• Subjects who experienced grade 3 or above immune-related adverse events (irAE) .
• Documented history of uncontrolled systemic diseases.
• Subjects who were allergic to any composition of investigational drug.
• Major surgery within 28 days prior to first dose of investigational drug.
• Subjects with active infection.
• Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
• Subjects with poor treatment compliance.
• Use of any investigational drug or device within 28 days prior to the first dose of investigational drug.
• Live vaccine was administered within 28 days prior to first dose of investigational drug.
• Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
6MW3211	6MW3211	6MW3211 injection, 45mg/kg, Q2W

Primary Outcome Measures

Name	Time	Method
Objective response rate	1 Year	Defined as the percentage of subjects who experience a best response of either CR or PR

Secondary Outcome Measures

Name	Time	Method
Complete response rate	1 Year	Defined as the percentage of subjects who experience a best response of CR
Duration of response	1 Year	Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause
Time to response	1 Year	Time from the date of first infusion to the date of confirmed CR or PR
Progression free survival	1 Year	Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause
Incidence of adverse events	Up to 28 days post last dose
PK Parameter	1 Year	Maximum concentration (Cmax)
Overall survival	1 Year	Time from the date of first infusion until the date of death from any cause