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A prospective, single-center, single-arm clinical study evaluating the efficacy and safety of Glofitamab in combination with Tislelizumab in patients with relapsed and refractory diffuse large B-cell lymphoma

A prospective, single-center, single-arm clinical study evaluating the efficacy and safety of Glofitamab in combination with Tislelizumab in patients with relapsed and refractory diffuse large B-cell lymphoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091464
Enrollment
Unknown
Registered
2024-10-29
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diffuse large B-cell lymphoma

Interventions

study group:Obinutuzumab 1000mg C1D1 Glotifamab 2.5mg C1D8 Glotifamab 10mg C1D15 Glotifamab 30mg D1(since Cycle2) T

Sponsors

The first affiliated hospital Zhejiang University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) According to the fifth edition of WHO Classification of lymphohematopoietic tumors, the patient was pathologically diagnosed as diffuse large B-cell lymphoma; 2) Age =18; 3) The patient has disease progression or recurrence after at least 2 lines of therapy and has received at least one anti-lymphoma regimen containing CD20; 4) PET-CT or CT/MRI shows at least one two-dimensional measurable lesion (maximum diameter > 1.5cm); 5) Women of childbearing age must be confirmed not to be pregnant through pregnancy tests, and are willing to take effective contraceptive measures during the test period and =12 months after the last dose of medication; Pregnant and lactating women cannot participate; All male subjects used contraception during the study period and =3 months after the last dose; 6) Can provide informed consent, can understand and comply with the study requirements.

Exclusion criteria

Exclusion criteria: 1) Patients with severe mental illness; 2) HIV infection; 3) prior CD20×CD3 dual antibody therapy; 4) prior organ transplantation or allogeneic stem cell transplantation; 5) other active tumors

Design outcomes

Primary

MeasureTime frame
Complete remission rate;

Secondary

MeasureTime frame
Objective Response Rate;Progression-free survival;overall survival;safety;

Countries

China

Contacts

Public ContactHongyan Tong

The first affiliated hospital Zhejiang University school of medicine

ruicostas610@sina.com+86 571 8723 5560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026