Actively Recruiting
Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-06-17
25
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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, patients eligible for CAR-T monotherapy undergo FC lymphodepletion followed by CAR-T infusion (2-4×10⁶/kg), while those eligible for CAR-T+ASCT receive conditioning chemotherapy with PBSC reinfusion on day 0 and CAR-T administration (2-4×10⁶/kg) on day +3 (±1). Patients demonstrating Deauville 4-5 or ctDNA positivity at day 28 post-CAR-T infusion subsequently receive four cycles of glofitamab consolidation therapy.
CONDITIONS
Official Title
Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed or refractory aggressive B-cell lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, or transformed large B-cell lymphoma
- Relapsed or refractory disease with either 2 or more prior therapies including anti-CD20 antibody and anthracycline chemotherapy with progression after last treatment, or failure of first-line immunochemotherapy by defined criteria
- Persistent metabolic activity or biopsy-proven residual disease after initial therapy for early treatment failure cohort
- Age between 18 and 65 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Absolute neutrophil count at least 1 x 10⁹/L, platelet count at least 75 x 10⁹/L unless due to bone marrow involvement
- Liver enzymes (ALT and AST) not more than 3 times the upper limit of normal
- Total bilirubin not more than 1.5 times upper limit of normal unless due to Gilbert's syndrome or non-hepatic causes
- Serum creatinine not more than 2 times upper limit of normal or creatinine clearance at least 40 mL/min
- Left ventricular ejection fraction within normal institutional range
- Oxygen saturation above 92% on room air
- Life expectancy of at least 3 months as assessed by investigator
You will not qualify if you...
- Primary central nervous system lymphoma
- Previous autologous or allogeneic hematopoietic stem cell transplantation
- Active hepatitis B or C infection with detectable viral DNA or RNA
- Uncontrolled infections, cardiovascular or cerebrovascular diseases, blood clotting disorders, or connective tissue diseases
- History of epilepsy or other central nervous system disorders
- Pregnancy or breastfeeding
- HIV infection
- History of other cancers unless disease-free for at least 5 years or cured of specific localized skin or cervical cancers
- Other conditions considered unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 022
Actively Recruiting
Research Team
W
WEI LIU
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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