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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/A

Inclusion 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
  • Autologous SCT within 6 months of C1D1, and allogeneic SCT within 3 months of 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

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