Relapsed/Refractory Diffuse Large B Cell Lymphoma
Conditions
Brief summary
Phase 1b: DLTs during the DLT observation period (21 days following Cycle 1 Day 1), Phase 2: OR per Lugano Response Classification Criteria 2014 as assessed by the investigator.
Detailed description
Phase 1b: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study treatment. Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing. The severity of CRS and ICANS as assessed according to ASTCT criteria., Phase 1b: OR, DoR, CR, DoCR, and PFS per Lugano Response Classification Criteria 2014 as assessed by the investigator., Phase 1b: Pre- and post-dose concentrations of PF-07901801., Phase 1b: ADAs and NAbs against PF-07901801., Phase 2: DoR, CR, DoCR, and PFS by investigator in participants with measurable disease by investigator per Lugano Response Classification Criteria 2014., Phase 2: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE V5.0), timing, seriousness, and relationship to study treatment. Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing. The Severity of CRS and ICANS will be assessed according to ASTCT criteria., Phase 2: Pre- and post-dose concentrations of PF-07901801., Phase 2: ADAs and NAbs against PF-07901801.
Interventions
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1b: DLTs during the DLT observation period (21 days following Cycle 1 Day 1), Phase 2: OR per Lugano Response Classification Criteria 2014 as assessed by the investigator. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1b: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study treatment. Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing. The severity of CRS and ICANS as assessed according to ASTCT criteria., Phase 1b: OR, DoR, CR, DoCR, and PFS per Lugano Response Classification Criteria 2014 as assessed by the investigator., Phase 1b: Pre- and post-dose concentrations of PF-07901801., Phase 1b: ADAs and NAbs against PF-07901801., Phase 2: DoR, CR, DoCR, and PFS by investigator in participants with measurable disease by investigator per Lugano Response Classification Criteria 2014., Phase 2: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE V5.0), timing, seriousness, and relationship to study treatment. Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing. The Severity of CRS a | — |
Countries
France, Germany, Spain
Outcome results
None listed