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.
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
Drug | Synonyms | Arms |
---|
tafasitamab | INCMOR00208 | tafasitamab + parsaclisib |
parsaclisib | INCB050465 | tafasitamab + 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
Name | Type | Description | Interventions |
---|
tafasitamab + parsaclisib | Experimental | 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 | |
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