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 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: INCMOR 0208-1012020-005591-35
• Study Type: interventional
• Target: 54
• Locations: 7 countries
• Sites: 50

Brief Summary

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

Non Hodgkin Lymphoma; Chronic Lymphocytic Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE )

  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.

  up to 1092 days

• Number of Participants With Any ≥Grade 3 TEAE

  An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. 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. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.

  up to 1092 days

• Number of Participants With Dose-limiting Toxicities (DLTs)

  A DLT was defined as the occurrence of any protocol-defined toxicity up to and including Day 28 (Cycle 1/Day 28), except those with a clear alternative explanation.

  up to 28 days

• Objective Response Rate Based on Investigator Assessment: Percentage of Participants With CR/CMR or PR/PMR According to Lugano Criteria for NHL and International Working Group for Chronic Lymphocytic Leukemia (iwCLL) Criteria for CLL

  Lugano complete response/complete metabolic response (CR/CMR): target nodes/masses of lymph nodes/extralymphatic sites (LNs/ELSs) regressed to ≤1.5 cm; no non-measured lesions; organ enlargement regressed to normal; no new lesions (NNLs); normal bone marrow. Lugano partial response/partial metabolic response (PR/PMR): LNs/ELSs, ≥50% decrease in the product of perpendicular diameters sum for multiple lesions; no/regressed non-measured lesions, no increase; organ enlargement; NNLs. iwCLL CR: no LNs ≥1.5 cm; spleen size \<13 cm/liver size normal; no constitutional symptoms; normal circulating lymphocyte count (CLC); ≥100 × 10\^9 platelets/L; hemoglobin ≥11 g/dL; normocellular, no CLL cells, no B-lymphoid nodules in marrow. iwCLL PR decrease of ≥50% in lymph nodes, liver and/or spleen, and CLC from baseline; constitutional symptoms; ≥100 × 10\^9 platelets/L or increase of ≥50% over baseline in platelet count and hemoglobin; presence of CLL cells, or of B-lymphoid nodules, or not done.

  up to 1002 days

Secondary Outcomes (8)

• Cmax of Tafasitamab When Given in Combination With Parsaclisib

  Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

• Tmax of Tafasitamab When Given in Combination With Parsaclisib

  Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

• AUClast of Tafasitamab When Given in Combination With Parsaclisib

  Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

• AUC0-inf of Tafasitamab When Given in Combination With Parsaclisib

  Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

• Clast of Tafasitamab When Given in Combination With Parsaclisib

  Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion

Study Arms (1)

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

Drug: tafasitamab; Drug: parsaclisib

Interventions

tafasitamab DRUG

tafasitamab will be administered at a protocol defined dose once a week for cycles 1-3 and every other week from cycle 4 until progression.

Also known as: INCMOR00208

tafasitamab + parsaclisib

parsaclisib DRUG

parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.

Also known as: INCB050465

tafasitamab + parsaclisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (50)

University of Alabama At Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35205, United States

Location

University of Southern California

Los Angeles, California, 90089, United States

Location

Indiana Blood and Marrow Transplantation

Indianapolis, Indiana, 46237, United States

Location

Community Health Network, Inc.

Indianapolis, Indiana, 46250, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Cancer Center For Blood Disorders

Bethesda, Maryland, 20817, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Clinical Research Alliance

New Hyde Park, New York, 11042, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107, United States

Location

Ordensklinikum Linz Gmbh Elisabethinen

Linz, A-4020, Austria

Location

Landeskrankenhaus Salzburg

Salzburg, 05020, Austria

Location

Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse

Vienna, 01140, Austria

Location

Institut Jules Bordet

Brussels, B-1070, Belgium

Location

Grand Hospital de Charleroi

Charleroi, 06000, Belgium

Location

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, 02650, Belgium

Location

Az Groeninge Campus Kennedylaan

Kortrijk, 08500, Belgium

Location

Universitair Ziekenhuis (Uz) Leuven

Leuven, 03000, Belgium

Location

AZ DELTA

Roeselare, 08800, Belgium

Location

University Hospital Brest

Brest, 29609, France

Location

Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

Nantes, 44093, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Justus-Liebig University

Giessen, 35392, Germany

Location

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131, Germany

Location

University Hospital Wurzburg

Würzburg, 97080, Germany

Location

S Orsolas University Hospital Seragnoli Institute of Hematology

Bologna, 40138, Italy

Location

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

Meldola, 47014, Italy

Location

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, 80131, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

Palermo, 90146, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Ospedale Santa Maria Delle Croci

Ravenna, 48121, Italy

Location

Irccs Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Hospital General Unviersitario de Alicante

Alicante, 03010, Spain

Location

Hospital General Universitario Vall D Hebron

Barcelona, 08035, Spain

Location

Hopital Sant Pau

Barcelona, 08036, Spain

Location

Ico Institut Catala D Oncologia

Barcelona, 08908, Spain

Location

Hospital Universitario San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Centro Integral Oncologico Clara Campal (Ciocc)

Madrid, 28050, Spain

Location

Hospital Universitario Quironsalud Madrid

Madrid, 28223, Spain

Location

Hospital Puerta de Hierro

Majadahonda, 28222, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41015, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Recurrence; Leukemia

Interventions

tafasitamab; parsaclisib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Limitations and Caveats

The sponsor chose to terminate the study early due to the strategic business decision to discontinue the evaluation of parsaclisib in clinical studies. Participants who continued to receive clinical benefit (in the opinion of the investigator) had the option to transition to a rollover study for continued supply of parsaclisib in combination with tafasitamab (including supply of tafasitamab to those who remained on tafasitamab alone).

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Oliver Manzke, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 22, 2021
• Study Start: September 16, 2021
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: February 4, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

DE (4); AU (3); US (10); ES (14); BE (6); FR (4); IT (9)