NCT06071871 A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma
| NCT ID | NCT06071871 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University College, London |
| Condition | Large B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2024-08-16 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 99 participants in total. It began in 2024-08-16 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
William Townsend
PRINCIPAL INVESTIGATOR
University College London Hospitals
Frequently Asked Questions
Who can join the NCT06071871 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Large B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06071871 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06071871 currently recruiting?
Yes, NCT06071871 is actively recruiting participants. Contact the research team at ctc.portal@ucl.ac.uk for enrollment information.
Where is the NCT06071871 trial being conducted?
This trial is being conducted at London, United Kingdom, London, United Kingdom, Manchester, United Kingdom, Nottingham, United Kingdom and 1 additional location.
Who is sponsoring the NCT06071871 clinical trial?
NCT06071871 is sponsored by University College, London. The principal investigator is William Townsend at University College London Hospitals. The trial plans to enroll 99 participants.