NCT04809467

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)

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukemia
• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	tafasitamab	tafasitamab will be administered at a protocol defined dose once a week for cycles 1-3 and every other week from cycle 4 until progression.
DRUG	parsaclisib	parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.

Timeline

• Start date: 2021-09-16
• Primary completion: 2024-10-22
• Completion: 2024-10-22
• First posted: 2021-03-22
• Last updated: 2026-02-04
• Results posted: 2026-01-29

Locations

50 sites across 7 countries: United States, Austria, Belgium, France, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study