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)

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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

Trial contacts and locations

50

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Data sourced from clinicaltrials.gov

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