A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma
Recruiting now · Phase 2
Conditions studied: Large B-cell Lymphoma
In brief
The PORTAL study will test a new combination of drugs (glofitamab, polatuzumab vedotin and obinutuzumab) in patients with large B-cell lymphoma (LBCL) that has come back (relapsed) or not responded to previous treatment. It will determine how safe and effective the combination of these cancer drugs is in treating LBCL before and after CAR-T cell therapy.
Key facts
- Study ID
- NCT06071871
- Run by
- University College, London
- People needed
- 99
- Starts
- 2024-08-16
- Expected to finish
- 2028-07-30
- Last updated by the study team
- 2024-12-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically proven CD20+ LBCL (with CD20 positivity at any timepoint) including diffuse large B cell lymphoma, high grade B cell lymphoma with MYC, BCL2 and/or BCL6 (double/triple hit lymphoma), high grade B cell lymphoma not otherwise specified (NOS), primary mediastinal B-cell lymphoma or transformed follicular lymphoma.
- Part 1: Relapsed or refractory disease and eligible for CAR T-cell therapy in the UK and in need of systemic bridging in the opinion of the local investigator.
- Part 2: Failed to achieve CMR (Deauville score 1-3) on PET scan 1-month post CAR-T or progressed at any point post CAR-T (patients in part 2 may have been previously enrolled in Part 1 and responded to Pola-Glofit bridging or be de novo patients who are naïve to this combination)
- At least one measurable target lesion
- Patient has recent archival biopsy tissue available or is willing to undergo a new biopsy.
- ECOG performance status:
- Part 1: ECOG PS 0/1
- Part 2: ECOG PS 0-2
- Life expectancy of ≥ 12 weeks
- Adequate haematological status.
- Adequate liver and renal function
- Negative test for hepatitis B, hepatitis C, HIV and SARS-CoV-2
You may not qualify if…
- Patients with known active infection
- Current ≥ Grade 2 peripheral neuropathy
- History of confirmed progressive multifocal leukoencephalopathy
- Current evidence of CNS lymphoma
- Patients with another invasive malignancy in the last 2 years
- Significant history of cardiovascular disease
- Active autoimmune disease or immune deficiency
- Severe neurological disorder
- Uncontrolled tumour-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Treatment with other standard anti-cancer radiotherapy/chemotherapy including investigational therapy and targeted therapy within 4 weeks prior to cycle 1 day 1
- Prior solid organ transplantation
- Prior allogeneic stem cell transplant
- Autologous SCT within 100 days prior to cycle 1 day 1
- Any history of immune related ≥ Grade 3 adverse events
- Ongoing corticosteroid use > 25 mg/day of prednisone or equivalent within 4 weeks prior to study treatment
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment
- Administration of a live, attenuated vaccine within 4 weeks prior to cycle 1 day 1
- History of severe allergic anaphylactic reactions to chimeric or humanised monoclonal antibodies or recombinant antibody-related fusion proteins.
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the obinutuzumab, polatuzumab vedotin and/or glofitamab formulation.
- Known or suspected history of HLH
Where it is running
- Kings College Hospital NHS Foundation Trust — London, United Kingdom (enrolling)
- University College London Hospitals NHS Foundation Trust — London, United Kingdom (enrolling)
- The Christie NHS Foundation Trust — Manchester, United Kingdom (enrolling)
- Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (enrolling)
- Churchill Hospital — Oxford, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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