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

Lymphoma Clinical Trial

Official title:

A Phase 2, Multicenter, Non-Randomized, Open-Label, Single-Arm Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Relapsed or Refractory Lymphoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05446688
• Other study ID #: 6MW3211-2022-CP201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: July 2022
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: Weili Zhao, Doctor
• Phone: 021-64370045
• Email: zwl_trail[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• 6MW3211
6MW3211 injection, 45mg/kg, Q2W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Outcome

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