A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)

• Status: Recruiting
• Trial end date: 2023-08-30
• Target enrollment: 0
• Participant gender: All

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: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion 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

Exclusion Criteria:

• 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