A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti CD19 Monoclonal Antibody Tafasitamab and the PI3Kδ Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
Description
Brief Summary
The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to
evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase
2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a
treatment option for adult participants with R/R B-cell malignancies.
Phase
N/AInclusion and Exclusion Criteria
- Histologically confirmed R/R B-cell malignancy: DLBCL (THRLBCL, EBV-positive DLBCL of the elderly, Grade 3b FL, HGBL with MYC and BCL2 and/or BCL6 rearrangements, transformed lymphoma); MCL ((with cyclin D1 overexpression or t(11;14); FL (Grade 1, 2, 3a); MZL (extranodal, nodal, splenic) ; CLL, or SLL
- Willingness to undergo biopsy
- At least 2 prior systemic treatment regimens, including prior treatment with an anti-CD20 antibody (all cohorts) or prior treatment with a BTK inhibitor (CLL/SLL)
- Relapsed, progressive, or refractory NHL or CLL
- For NHL/SLL: Radiographically measurable nodal or extranodal disease (all cohorts except CLL)
- ECOG-PS 0
- 2
- LVEF ≥ 50%
- Adequate renal, hepatic, bone marrow function
- Any other histological type of lymphoma
- Primary or secondary CNS lymphoma
- Anticancer and/or investigational therapy within the past 30 days or 5 half-lives
- Allogeneic stem cell transplantation within the past 6 months, or ASCT within 3 months before C1D1
- Previous treatment with CD19-targeted therapy or PI3K inhibitors
- Clinically significant cardiac disease
- Other malignancy within the past 3 years
- Active graft-versus-host disease
- Stroke or intracranial hemorrhage within the past 6 months
- Chronic or current active infectious disease
- Positive virus serology for HCV, HBV, HIV
- Currently pregnant or breastfeeding
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.