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

NCT05446688 | Unknown Phase 2

• 1 other identifier: 6MW3211-2022-CP201
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Defined as the percentage of subjects who experience a best response of either CR or PR

  1 Year

Secondary Outcomes (7)

• Complete response rate

  1 Year

• Duration of response

  1 Year

• Time to response

  1 Year

• Progression free survival

  1 Year

• Overall survival

  1 Year

Study Arms (1)

6MW3211

EXPERIMENTAL

6MW3211 injection, 45mg/kg, Q2W

Drug: 6MW3211

Interventions

6MW3211 DRUG

6MW3211 injection, 45mg/kg, Q2W

6MW3211

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Saijuan Chen, Doctor

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Weili Zhao, Doctor

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weili Zhao, Doctor

CONTACT

021-64370045; zwl_trail@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 7, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 7, 2022

Record last verified: 2022-07