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) (topMIND)

Incyte

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma

Treatments: Drug: tafasitamab; Drug: parsaclisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04809467

INCMOR 0208-101

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

54 participants in 1 patient group

tafasitamab + parsaclisib

Experimental group

Description:

Participants will be assigned to disease specific cohorts based on the histology of their underlying disease. Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL

Treatment:

Drug: parsaclisib

Drug: tafasitamab