Treatment for relapsed or refractory aggressive B-cell lymphoma using bispecific antibodies and CAR-T therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves two sequential treatment phases for patients with relapsed or refractory aggressive B-cell lymphoma. In the first phase, participants receive two cycles of glofitamab, potentially combined with other selected agents. Those who qualify then proceed to the second phase, where they receive CAR-T cell therapy, either alone or in combination with autologous stem cell transplantation, followed by additional glofitamab treatment if necessary. The study aims to evaluate the efficacy of this combined therapeutic approach in improving patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Dehui Zou — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Wei Liu
• Email: liuwei@ihcams.ac.cn
• Phone: 86-022-23608461

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

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• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

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• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

  This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.

  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

• Loncastuximab tesirine plus rituximab as bridging therapy before CAR-T for relapsed or refractory large B‑cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.