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

NCT05222555 | Active Not Recruiting Phase 1 Results DMC FDA Drug

• 3 other identifiers: MOR208C1152023-507993-42-002021-003855-40
• Study Type: interventional
• Target: 53
• Locations: 9 countries
• Sites: 62

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

Keywords

monoclonal antibody; CD19; tafasitamab

Outcome Measures

Primary Outcomes (2)

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

  An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Therefore, an AE could be any unfavorable or unintended sign (including an abnormal laboratory finding) or symptom temporally associated with the use of study treatment. A TEAE was defined as any AE that started or worsened after the first dose of study treatment until 90 days after the last dose of the study treatment. An AE that was present prior to study drug administration but increased in severity after treatment start was also included as a TEAE.

  up to approximately 2 years

• Number of Participants With Any ≥Grade 3 TEAE

  The toxicity grade of TEAEs was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) using the following definitions: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal; local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.). 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 intervention indicated. Grade 5: death related to AE.

  up to approximately 2 years

Secondary Outcomes (6)

• Ctrough of Tafasitamab After 3 and 12 Treatment Cycles

  predose on Cycle 3 Day 15; predose on Cycle 12 Day 28 (up to approximately 1 year [after twelve 28-day cycles])

• Cmax of Tafasitamab After 3 Treatment Cycles

  30 minutes after the end of tafasitamab infusion on Cycle 3 Day 15 (up to approximately 85 days [after three 28-day cycles])

• Best Objective Response Rate (ORR) by Investigator Assessment up to Treatment Cycle 12

  up to 19.8 months

• Duration of Response (DoR) by Investigator Assessment

  up to approximately 64 months (approximately 5 years)

• Progression-free Survival (PFS) by Investigator Assessment

  up to approximately 64 months (approximately 5 years)

Study Arms (1)

Treatment (Tafasitamab + Lenalidomide)

EXPERIMENTAL

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.

Drug: Tafasitamab; Drug: Lenalidomide

Interventions

Tafasitamab DRUG

tafasitamab will be administered intravenously at protocol defined timepoints

Also known as: INCMOR00208, MOR00208, Xmab5574

Treatment (Tafasitamab + Lenalidomide)

Lenalidomide DRUG

lenalidomide will be administered orally at protocol defined timepoints

Treatment (Tafasitamab + Lenalidomide)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of giving signed informed consent
• Age 18 years or older
• Histologically confirmed diagnosis of DLBCL
• Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study.
• 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
• Patients not considered in the opinion of the investigator eligible to undergo intensive salvage therapy including ASCT
• 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

You may not qualify if:

• Patients who are legally institutionalized or concurrent enrollment in another interventional clinical study
• Patients who have:
• other histological type of lymphoma
• a history of "double/triple hit" genetics
• 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
• 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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (62)

Morristown Memorial Hospital

Morristown, New Jersey, 07960-6459, United States

Location

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

Dallas, Texas, 75246-2092, United States

Location

Vista Oncology

Olympia, Washington, 98506, United States

Location

UK St. Pölten

Sankt Pölten, Lower Austria, 3100, Austria

Location

Klinikum Wels Grieskirchen

Wels, Upper Austria, 4600, Austria

Location

Universitatsklinikum Salzburg

Salzburg, 5020, Austria

Location

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

Fakultni nemocnice Ostrava

Ostrava, 708 52, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Vseobecna Fakultni Nemocnice V Praze

Prague, 128 08, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

Grenoble, Isère, 38043, France

Location

CHU Nantes

Nantes, Loire-Atlantique, 44000, France

Location

Centre Hospitalier Le Mans

Le Mans, Sarthe, 72000, France

Location

CHU de Poitiers

Poitiers, Vienne, 86021, France

Location

Soroka University Medical Centre

Beersheba, Southern District, 84101, Israel

Location

Shamir Medical Center Assaf Harofeh

Be’er Ya‘aqov, 70300, Israel

Location

Lady Davis Carmel Medical Center

Haifa, 34362, Israel

Location

Hadassah Medical Center - Hadassah Ein Kerem

Jerusalem, 91120, Israel

Location

ZIV Medical Center

Safed, 13100, Israel

Location

Ospedale Santa Maria Delle Croci

Ravenna, Emilia-Romagna, 48121, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

Milan, Lombardy, 20162, Italy

Location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, 27100, Italy

Location

ASST di Monza - Azienda Ospedaliera San Gerardo

Monza, Monza E Brianza, 20900, Italy

Location

Fondazione del Piemonte per l'Oncologia (IRCCS)

Candiolo, Piedmont, 10060, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56127, Italy

Location

Azienda Ospedaliera di Perugia

Perugia, Umbria, 6122, Italy

Location

Centrum Medyczne Poznan - PRATIA - PPDS

Skórzewo, Greater Poland Voivodeship, 60-185, Poland

Location

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

Location

Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

Wroclaw, Lower Silesian Voivodeship, 53-439, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Szpital Wojewodzki w Opolu

Opole, Opole Voivodeship, 45-061, Poland

Location

Szpitale Pomorskie Sp. z o. o.

Gdynia, 81-519, Poland

Location

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, 31-501, Poland

Location

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

Lodz, 93-513, Poland

Location

SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

Olsztyn, 10-228, Poland

Location

Nasz Lekarz Osrodek Badan Klinicznych

Torun, 87-100, Poland

Location

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

Suwon, Gyeonggido, 16247, South Korea

Location

Dong-A University Medical Center

Busan, 49201, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Yeungnam University Hospital

Daegu, 42415, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Chonbuk National University Hospital

Jeonju, 54907, South Korea

Location

Hanyang University Medical Center

Seoul, 4763, South Korea

Location

Asan Medical Center - PPDS

Seoul, 5505, South Korea

Location

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

Seoul, 7345, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 7198, Spain

Location

Institut Catala d'Oncologia Girona

Girona, 17007, Spain

Location

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, 8907, Spain

Location

Hospital U. Infanta Leonor

Madrid, 28031, Spain

Location

MD Anderson Madrid

Madrid, 28033, Spain

Location

Hospital U. Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital U. Quironsalud Madrid

Madrid, 28223, Spain

Location

Complejo Asistencial Universitario de Salamanca - H. Clinico

Salamanca, 37007, Spain

Location

Hospital U. Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitari La Fe

Valencia, 46026, Spain

Location

Related Links

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

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

tafasitamab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Incyte Medical Director

  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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 3, 2022
• Study Start: July 19, 2022
• Primary Completion: July 17, 2024
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 16, 2026
• Results First Posted: July 28, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); KR (12); AU (3); FR (4); IL (5); ES (11); CZ (5); IT (8); PL (11)