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New treatment option for Relapsed or Refractory Aggressive B-cell Lymphoma
Official title Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma
ClinicalTrials.gov ID: NCT06996132
What this study is testing
What is Glofitamab?
Glofitamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory aggressive b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study consists of two sequential treatment phases. In the first phase, patients with r/r aggressive B-NHL receive two cycles of glofitamab ± investigator-selected agents.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients with relapsed/refractory aggressive B-cell lymphoma, including the following subtypes: diffuse large B-cell lymphoma (DLBCL), high-grade...
- Relapsed or refractory disease, meeting criteria for one of the following cohorts: Cohort 1 (Relapsed/Refractory Disease):
- ≥2 prior lines of therapy (including both anti-CD20 monoclonal antibody and anthracycline-based chemotherapy) with documented progression following...
- Failure of first-line immunochemotherapy (containing anti-CD20 antibody and anthracycline) defined by any of:
- Relapse/progression within 12 months of treatment completion; OR
You likely can't join if
- Confirmed primary central nervous system lymphoma;
- Prior autologous or allogeneic hematopoietic stem cell transplantation;
- Active HBV or HCV infection, defined as HBV-DNA or HCV-RNA levels above the upper limit of detection.
- Uncontrolled comorbidities include infectious diseases, cardiovascular/cerebrovascular disorders, coagulopathies, and connective tissue diseases.
- History of epilepsy or other central nervous system disorders;
- Pregnancy or lactation;
See the full eligibility criteria
- Patients with relapsed/refractory aggressive B-cell lymphoma, including the following subtypes: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), or transformed large B-cell lymphoma.
- Relapsed or refractory disease, meeting criteria for one of the following cohorts: Cohort 1 (Relapsed/Refractory Disease):
- ≥2 prior lines of therapy (including both anti-CD20 monoclonal antibody and anthracycline-based chemotherapy) with documented progression following last treatment; OR
- Failure of first-line immunochemotherapy (containing anti-CD20 antibody and anthracycline) defined by any of:
- Relapse/progression within 12 months of treatment completion; OR
- Progressive disease during first-line therapy; OR
- Stable disease as best response after 4 cycles; OR
- Partial response as best response after 6 cycles. Cohort 2 (Early Treatment Failure):
- Persistent metabolic activity (Deauville 5) on PET-CT after 2 cycles of first-line immunochemotherapy; OR
- Biopsy-proven residual disease following initial therapy.
- Age ≥18 years and ≤65 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Hematologic parameters at screening must meet the following (unless due to bone marrow involvement):
- Absolute neutrophil count (ANC) ≥1×10⁹/L,
- Platelet count (PLT) ≥75×10⁹/L.
- Biochemical parameters at screening must meet the following:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN);
- Total bilirubin (TBIL) ≤1.5×ULN (unless due to Gilbert's syndrome or non-hepatic causes);
- Serum creatinine (Cr) ≤2×ULN OR creatinine clearance ≥40 mL/min.
- Left ventricular ejection fraction (LVEF) within institutional normal range by echocardiography.
- Baseline oxygen saturation \>92% on room air.
- Life expectancy ≥3 months as assessed by the investigator.
- Confirmed primary central nervous system lymphoma;
- Prior autologous or allogeneic hematopoietic stem cell transplantation;
- Active HBV or HCV infection, defined as HBV-DNA or HCV-RNA levels above the upper limit of detection.
- Uncontrolled comorbidities include infectious diseases, cardiovascular/cerebrovascular disorders, coagulopathies, and connective tissue diseases.
- History of epilepsy or other central nervous system disorders;
- Pregnancy or lactation;
- HIV infection;
- History of other malignancies unless:
- Disease-free for ≥5 years, or
- Previously cured of the following:
- Non-melanoma skin cancers (basal cell carcinoma, squamous cell carcinoma, or related localized cutaneous malignancies)
- Carcinoma in situ of cervix
- Other conditions deemed ineligible by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.