Actively Recruiting
The Efficacy and Safety of Glofitamab in Combination With PD-1 Antibody and Lenalidomide in Patients With Relapsed/Refractory Large B-cell Lymphoma (LBCL) With TP53 Aberrations: A Prospective, Multicenter, Phase II Clinical Study
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-11-20
24
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase II, open-label, single-arm, multicenter study designed to evaluate the safety and efficacy of a novel combination therapy-Glofitamab, a PD-1 inhibitor, and Lenalidomide (Glofit-PD-1-Len)-in patients with TP53-aberrant relapsed or refractory large B-cell lymphoma (R/R LBCL). The study will enroll 24 participants and utilize a Simon two-stage design to assess the best complete response rate (BCR), defined as achieving complete remission (CR) per 2014 Lugano criteria during the treatment period. Secondary endpoints include overall response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), and MRD negativity rate at the end of treatment. Safety and tolerability will also be evaluated. This study addresses a critical unmet need for patients with TP53-mutant R/R LBCL, who typically have a poor prognosis under current treatment options.
CONDITIONS
Official Title
The Efficacy and Safety of Glofitamab in Combination With PD-1 Antibody and Lenalidomide in Patients With Relapsed/Refractory Large B-cell Lymphoma (LBCL) With TP53 Aberrations: A Prospective, Multicenter, Phase II Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form before any study-specific procedures.
- Age 18 years or older at the time of consent.
- Histologically confirmed large B-cell lymphoma (LBCL) with CD20 expression, including subtypes such as diffuse large B-cell lymphoma not otherwise specified, transformed follicular lymphoma, grade 3B follicular lymphoma, high-grade B-cell lymphoma, intravascular large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and Epstein-Barr virus-positive LBCL.
- Relapsed or refractory LBCL defined as relapse after remission lasting longer than 6 months or failure to achieve remission or progression within 6 months after last therapy.
- Confirmed TP53 deletion or mutation by FISH or NGS.
- Not eligible for autologous stem cell transplantation due to age 70 years or older, end-stage organ dysfunction, ECOG performance status of 2 or higher, patient decision, or other comorbidities.
- Measurable disease with at least one lymph node lesion 1.5 cm or larger, or one extranodal lesion 1.0 cm or larger.
- ECOG performance status of 0, 1, or 2.
- Life expectancy of at least 12 weeks.
- Adequate blood function unless due to bone marrow or spleen involvement by lymphoma: absolute neutrophil count 1.0 x 10^9/L or higher, platelets 50 x 10^9/L or higher, hemoglobin 80 g/L or higher.
- Willingness to follow study procedures including contraception requirements for those of reproductive potential.
You will not qualify if you...
- Prior allogeneic stem cell transplantation or organ transplantation.
- Active lymphoma involvement in the central nervous system.
- Active autoimmune diseases requiring immune suppressive treatment.
- Uncontrolled systemic infections, including active hepatitis B, hepatitis C, or HIV.
- Previous treatment with Glofitamab, other CD20xCD3 bispecific antibodies, or PD-1 inhibitors combined with Lenalidomide.
- History of severe allergic reactions to monoclonal antibodies or study drug components.
- Concurrent participation in another investigational study.
- Use of systemic immunosuppressive therapy within 14 days before enrollment, except corticosteroids for lymphoma treatment or adverse effect prevention.
- Pregnant or breastfeeding women.
- Any psychological, social, or medical condition that might interfere with study participation or safety, as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
W
Wei Xu Doctor
CONTACT
J
Jinhua Liang M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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