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RECRUITING

NCT06996132

PHASE2

Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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, 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.

Official title: A Phase 2 Clinical Study of CD20×CD3 Bispecific Antibody-Based Salvage Therapy Followed by CAR-T With or Without ASCT in R/R Aggressive B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-09

Completion Date

2027-12-30

Last Updated

2025-06-17

Healthy Volunteers

Conditions

Relapsed or Refractory Aggressive B-cell Lymphoma

Interventions

DRUG

Glofitamab

Glofitamab is administered as monotherapy or in combination with investigator-selected agents (including but not limited to chemotherapy, ADCs, BTK inhibitors, etc.) for 2 cycles.

DRUG

Chimeric Antigen Receptor T Cells (CAR-T)

After two cycles of glofitamab-based salvage therapy, single-target or dual-target CAR-T cells directed against CD19, CD20, and/or CD22 are infused following lymphodepleting (fludarabine + cyclophosphamide) or myeloablative conditioning, at a dose of 2-4 × 10⁶/kg.

Inclusion Criteria: 1. 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. 2. Relapsed or refractory disease, meeting criteria for one of the following cohorts: Cohort 1 (Relapsed/Refractory Disease): 1. ≥2 prior lines of therapy (including both anti-CD20 monoclonal antibody and anthracycline-based chemotherapy) with documented progression following last treatment; OR 2. 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. 3. Age ≥18 years and ≤65 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 5. 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. 6. 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. 7. Left ventricular ejection fraction (LVEF) within institutional normal range by echocardiography. 8. Baseline oxygen saturation \>92% on room air. 9. Life expectancy ≥3 months as assessed by the investigator. Exclusion Criteria: 1. Confirmed primary central nervous system lymphoma; 2. Prior autologous or allogeneic hematopoietic stem cell transplantation; 3. Active HBV or HCV infection, defined as HBV-DNA or HCV-RNA levels above the upper limit of detection. 4. Uncontrolled comorbidities include infectious diseases, cardiovascular/cerebrovascular disorders, coagulopathies, and connective tissue diseases. 5. History of epilepsy or other central nervous system disorders; 6. Pregnancy or lactation; 7. HIV infection; 8. History of other malignancies unless: 1. Disease-free for ≥5 years, or 2. 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 9. Other conditions deemed ineligible by investigators.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China