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

Mabwell Bioscience

Status and phase

Not yet enrolling

Phase 2

Conditions

Lymphoma

Treatments

Drug: 6MW3211

Study type

Interventional

Funder types

Industry

Identifiers

NCT05446688

6MW3211-2022-CP201

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.