Status:
RECRUITING
Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Relapsed or Refractory Aggressive B-cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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. In the second phase, pat...
Detailed Description
The study comprises two sequential treatment phases. In the first phase, eligible patients with r/r aggressive B-NHL receive 2 cycles of glofitamab ± X regimen (where X includes but is not limited to ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06996132
Start Date
May 9 2025
End Date
December 30 2027
Last Update
June 17 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 022