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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)

NCT04809467

Description:

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.

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Diffuse Large B-Cell Lymphoma
  • EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Follicular Lymphoma
  • High Grade B-Cell Lymphoma with MYC and BCL2 and/or BCL6 Rearrangements
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Non-Hodgkin Lymphoma
  • Primary Central Nervous System Lymphoma
  • Small Lymphocytic Lymphoma
  • T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
  • Transformed Non-Hodgkin Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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)
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: INCMOR 0208-101
  • NCT ID: NCT04809467

Conditions

  • Chronic Lymphocytic Leukemia
  • Non Hodgkin Lymphoma

Interventions

DrugSynonymsArms
tafasitamabINCMOR00208tafasitamab + parsaclisib
parsaclisibINCB050465tafasitamab + parsaclisib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
tafasitamab + parsaclisibExperimentalParticipants 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
  • tafasitamab
  • parsaclisib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1b : Number of Treatment Emergent Adverse Events
Time Frame:Up to 25 months
Safety Issue:
Description:Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Secondary Outcome Measures

Measure:Phase 2a : Overall Response Rate
Time Frame:Up to 25 months
Safety Issue:
Description:Defined as the percentage of participants experiencing a best response of Complete Response/Complete Metabolic Response (CR/CMR) or Partial Response/Partial Metabolic Response (PR/PMR) according to the Lugano criteria (Cheson et al 2014) for NHL and the iwCLL criteria (Hallek et al 2018) for CLL.
Measure:Pharmacokinetics Parameter : Cmax of tafasitamab
Time Frame:Up to 24 months
Safety Issue:
Description:Maximum Observed Plasma Concentration of tafasitamab
Measure:Pharmacokinetics Parameter : Cmin of tafasitamab
Time Frame:Up to 24 months
Safety Issue:
Description:Minimum Observed Plasma Concentration of tafasitamab
Measure:Pharmacokinetics Parameter : Tmax of tafasitamab
Time Frame:Up to 24 months
Safety Issue:
Description:Time to reach maximum plasma concentration of tafasitamab
Measure:Pharmacokinetics Parameter : AUC(t) of tafasitamab
Time Frame:Up to 24 months
Safety Issue:
Description:Area under the concentration-time curve from time zero to time of tafasitamab
Measure:Pharmacokinetics Parameter : Ctrough of tafasitamab
Time Frame:Up to 24 months
Safety Issue:
Description:C trough concentration of tafasitamab

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Relapsed or Refractory
  • Leukemia
  • tafasitamab
  • parsaclisib
  • MOR00208
  • INCMOR00208

Last Updated

August 12, 2021