Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| parsaclisib | Drug | — | UNRESOLVED |
| tafasitamab | Drug | Tafasitamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- tafasitamab + parsaclisib
- 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
- interventionNames
- Drug: tafasitamab
- Drug: parsaclisib
Primary outcomes (4)
- measure
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE )
- timeFrame
- up to 1092 days
- description
- An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available