Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

NCT ID: NCT05222555

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-19
• Study Completion Date: 2027-11-30

Brief Summary

This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (Tafasitamab + Lenalidomide)

Treatment:

Tafasitamab will be combined with lenalidomide in R/R DLBCL patients.

Dose:

Cohort 1: The dose of tafasitamab will be level 1 high dose in combination with the approved dose

Cohort 2: The dose of tafasitamab will be level 2 high dose in combination with the approved dose

Expansion Cohort: The dose of tafasitamab will be the dose that is deemed safe and tolerable as determined from cohort 1 & cohort 2

Treatment consisting of tafasitamab and lenalidomide combination will be administered until disease progression, unacceptable toxicity, or discontinuation for any other reason, whichever comes first. Lenalidomide can be given for up to 12 cycles in total, after which patients can continue with tafasitamab as monotherapy until progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Tafasitamab

Intervention Type: DRUG

tafasitamab will be administered intravenously at protocol defined timepoints

Lenalidomide

Intervention Type: DRUG

lenalidomide will be administered orally at protocol defined timepoints

Interventions

Tafasitamab

tafasitamab will be administered intravenously at protocol defined timepoints

Intervention Type: DRUG

Lenalidomide

lenalidomide will be administered orally at protocol defined timepoints

Intervention Type: DRUG

Other Intervention Names

INCMOR00208; MOR00208; Xmab5574

Eligibility Criteria

Inclusion Criteria

1. Capable of giving signed informed consent

2. Age 18 years or older

3. Histologically confirmed diagnosis of DLBCL

4. Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study.

5. Patients must have:

• relapsed and/or refractory disease
• at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
• received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy
• Eastern Cooperative Oncology Group 0 to 2

6. Patients not considered in the opinion of the investigator eligible to undergo intensive salvage therapy including ASCT

7. Patients must meet the following laboratory criteria at screening:

• absolute neutrophil count ≥1.5 × 10^9/L
• platelet count ≥90 × 10^9/L
• total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
• alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or <5 × ULN in cases of liver involvement
• serum creatinine clearance ≥ 60 mL/minute

8. Patients who received previous CD19 targeted therapy (other than tafasitamab) must have CD19 positive lymphoma confirmed on a biopsy taken since completing the prior CD19 targeted therapy

9. Patients with primary refractory disease who received at least one, but no more than three previous systemic regimens (including a CD20 targeted therapy)

Exclusion Criteria

1. Patients who are legally institutionalized or concurrent enrollment in another interventional clinical study

2. Patients who have:

• other histological type of lymphoma
• a history of "double/triple hit" genetics

3. Patients who have, within 14 days prior to Day 1 dosing:

• not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
• undergone major surgery (with 4 weeks) or suffered from significant traumatic injury
• received live vaccines (within 4 weeks).
• required parenteral antimicrobial therapy for active, intercurrent infections

4. Patients who:

• have not recovered sufficiently from the adverse toxic effects of prior therapies
• were previously treated with IMiDs® (e.g. thalidomide, LEN)
• have history of hyper sensitivity to compounds of similar biological or chemical composition to tafasitamab IMiDs® and/or the excipients contained in the study treatment formulations
• have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
• have undergone previous allogenic stem cell transplantation
• have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
• concurrently use other anticancer or experimental treatments

5. History of other malignancy that could affect compliance with the protocol or interpretation of results. Exceptions

• Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for >2 years prior to enrollment are eligible
• Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible

6. Patients with:

• positive hepatitis B and/or C serology.
• known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
• CNS lymphoma involvement
• history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent
• history or evidence of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• gastrointestinal (GI) abnormalities (issue with absorption) including the inability to take oral medication
• history or evidence of severe hepatic impairment (total serum bilirubin > 3mg/dL), jaundice unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma
• history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class
• any other medical condition which, in the investigator's opinion, makes the patient unsuitable for the study

7. Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from breast feeding and donating eggs; agreement to ongoing pregnancy testing during the course of the study, and after study therapy has ended Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Incyte Medical Director

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Morristown Memorial Hospital

Morristown, New Jersey, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR

Dallas, Texas, United States

Vista Oncology

Olympia, Washington, United States

UK St. Pölten

Sankt Pölten, Lower Austria, Austria

Klinikum Wels Grieskirchen

Wels, Upper Austria, Austria

Universitatsklinikum Salzburg

Salzburg, , Austria

Fakultni nemocnice Brno

Brno, , Czechia

Fakultni nemocnice Ostrava

Ostrava, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, , Czechia

Fakultni nemocnice v Motole

Prague, , Czechia

Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

Grenoble, Isère, France

CHU Nantes

Nantes, Loire-Atlantique, France

Centre Hospitalier Le Mans

Le Mans, Sarthe, France

CHU de Poitiers

Poitiers, Vienne, France

Soroka University Medical Centre

Beersheba, Southern District, Israel

Shamir Medical Center Assaf Harofeh

Be’er Ya‘aqov, , Israel

Lady Davis Carmel Medical Center

Haifa, , Israel

Hadassah Medical Center - Hadassah Ein Kerem

Jerusalem, , Israel

ZIV Medical Center

Safed, , Israel

Ospedale Santa Maria Delle Croci

Ravenna, Emilia-Romagna, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

Milan, Lombardy, Italy

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, Italy

ASST di Monza - Azienda Ospedaliera San Gerardo

Monza, Monza E Brianza, Italy

Fondazione del Piemonte per l'Oncologia (IRCCS)

Candiolo, Piedmont, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Azienda Ospedaliera di Perugia

Perugia, Umbria, Italy

Centrum Medyczne Poznan - PRATIA - PPDS

Skórzewo, Greater Poland Voivodeship, Poland

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, Poland

Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

Wroclaw, Lower Silesian Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, Poland

Szpital Wojewodzki w Opolu

Opole, Opole Voivodeship, Poland

Szpitale Pomorskie Sp. z o. o.

Gdynia, , Poland

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, , Poland

SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

Olsztyn, , Poland

Nasz Lekarz Osrodek Badan Klinicznych

Torun, , Poland

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggido, South Korea

Dong-A University Medical Center

Busan, , South Korea

Pusan National University Hospital

Busan, , South Korea

Kosin University Gospel Hospital

Busan, , South Korea

Yeungnam University Hospital

Daegu, , South Korea

Daegu Catholic University Medical Center

Daegu, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Chonbuk National University Hospital

Jeonju, , South Korea

Hanyang University Medical Center

Seoul, , South Korea

Asan Medical Center - PPDS

Seoul, , South Korea

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Institut Catala d'Oncologia Girona

Girona, , Spain

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, , Spain

Hospital U. Infanta Leonor

Madrid, , Spain

MD Anderson Madrid

Madrid, , Spain

Hospital U. Ramon y Cajal

Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital U. Quironsalud Madrid

Madrid, , Spain

Complejo Asistencial Universitario de Salamanca - H. Clinico

Salamanca, , Spain

Hospital U. Virgen del Rocio

Seville, , Spain

Hospital Universitari La Fe

Valencia, , Spain

Countries

United States; Austria; Czechia; France; Israel; Italy; Poland; South Korea; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://incyteclinicaltrials.com/studies/mor208c115

Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

Other Identifiers

2023-507993-42-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-003855-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MOR208C115

Identifier Type: -

Identifier Source: org_study_id