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

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.