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

A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Drug: Tafasitamab; Drug: Lenalidomide

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Universitätsklinikum Salzburg
  • Lower Austria
    • Sankt Pölten, Lower Austria, Austria, 3100
      • UK St. Pölten
  • Upper Austria
    • Wels, Upper Austria, Austria, 4600
      • Klinikum Wels Grieskirchen
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Ostrava, Czechia, 708 52
    • Fakultni Nemocnice Ostrava
  • Prague, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
  • Prague, Czechia, 100 34
    • Fakultní nemocnice Královské Vinohrady
  • Prague, Czechia, 150 06
    • Fakultni nemocnice v Motole
• France
  • Isère
    • Grenoble, Isère, France, 38043
      • Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44000
      • CHU Nantes
  • Sarthe
    • Le Mans, Sarthe, France, 72000
      • Centre Hospitalier Le Mans
  • Vienne
    • Poitiers, Vienne, France, 86021
      • Chu de Poitiers
• Israel
  • Be’er Ya‘aqov, Israel, 70300
    • Shamir Medical Center Assaf Harofeh
  • Haifa, Israel, 34362
    • Lady Davis Carmel Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center - Hadassah Ein Kerem
  • Safed, Israel, 13100
    • Ziv Medical Center
  • Southern District
    • Beersheba, Southern District, Israel, 84101
      • Soroka University Medical Centre
• Italy
  • Emilia-Romagna
    • Ravenna, Emilia-Romagna, Italy, 48121
      • Ospedale Santa Maria delle Croci
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
    • Milan, Lombardy, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
    • Pavia, Lombardy, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo di Pavia
  • Monza E Brianza
    • Monza, Monza E Brianza, Italy, 20900
      • ASST di Monza - Azienda Ospedaliera San Gerardo
  • Piedmont
    • Candiolo, Piedmont, Italy, 10060
      • Fondazione del Piemonte per l'Oncologia (IRCCS)
  • Tuscany
    • Pisa, Tuscany, Italy, 56127
      • Azienda Ospedaliero Universitaria Pisana
  • Umbria
    • Perugia, Umbria, Italy, 6122
      • Azienda Ospedaliera di Perugia
• Poland
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie Sp. z o. o.
  • Krakow, Poland, 31-501
    • SP ZOZ Szpital Uniwersytecki w Krakowie
  • Lodz, Poland, 93-513
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • Olsztyn, Poland, 10-228
    • SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
  • Torun, Poland, 87-100
    • Nasz Lekarz Osrodek Badan Klinicznych
  • Greater Poland Voivodeship
    • Skórzewo, Greater Poland Voivodeship, Poland, 60-185
      • Centrum Medyczne Poznan - PRATIA - PPDS
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-510
      • Pratia MCM Krakow
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
      • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
    • Wroclaw, Lower Silesian Voivodeship, Poland, 53-439
      • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
  • Opole Voivodeship
    • Opole, Opole Voivodeship, Poland, 45-061
      • Szpital Wojewodzki w Opolu
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Busan, South Korea, 49267
    • Kosin University Gospel Hospital
  • Busan, South Korea, 49201
    • Dong-A University Medical Center
  • Daegu, South Korea, 42472
    • Daegu Catholic University Medical Center
  • Daegu, South Korea, 42415
    • Yeungnam University Hospital
  • Incheon, South Korea, 21565
    • Gachon University Gil Medical Center
  • Jeonju, South Korea, 54907
    • Chonbuk National University Hospital
  • Seoul, South Korea, 5505
    • Asan Medical Center - PPDS
  • Seoul, South Korea, 4763
    • Hanyang University Medical Center
  • Seoul, South Korea, 7345
    • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Ulsan, South Korea, 44033
    • Ulsan University Hospital
  • Gyeonggido
    • Suwon, Gyeonggido, South Korea, 16247
      • The Catholic University of Korea, St. Vincent'S Hospital
• Spain
  • Girona, Spain, 17007
    • Institut Catala D'Oncologia Girona
  • L'Hospitalet de Llobregat, Spain, 8907
    • ICO l'Hospitalet - Hospital Duran i Reynals
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28034
    • Hospital U. Ramon y Cajal
  • Madrid, Spain, 28031
    • Hospital U. Infanta Leonor
  • Madrid, Spain, 28033
    • MD Anderson Madrid
  • Madrid, Spain, 28223
    • Hospital U. Quironsalud Madrid
  • Salamanca, Spain, 37007
    • Complejo Asistencial Universitario de Salamanca - H. Clinico
  • Seville, Spain, 41013
    • Hospital U. Virgen del Rocio
  • Valencia, Spain, 46026
    • Hospital Universitari La Fe
  • Balearic Islands
    • Palma de Mallorca, Balearic Islands, Spain, 7198
      • Hospital Son Llatzer
• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960-6459
      • Morristown Memorial Hospital
  • Texas
    • Dallas, Texas, United States, 75246-2092
      • Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR
  • Washington
    • Olympia, Washington, United States, 98506
      • Vista Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Major 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)

Major 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Tafasitamab; tafasitamab will be administered intravenously at protocol defined timepoints; Other Names: MOR00208; INCMOR00208; Xmab5574; Drug: Lenalidomide; lenalidomide will be administered orally at protocol defined timepoints

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ctrough of Tafasitamab After 3 and 12 Treatment Cycles	Ctrough was defined as the minimum concentration of tafasitamab.	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	Cmax was defined as the maximum observed plasma concentration of tafasitamab.	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	ORR was defined as the percentage of participants with complete response (CR: disappearance of all evidence disease) or partial response (PR: regression of measurable disease and no new sites) as the best response achieved at any time during the study. Only responses of CR or PR that were documented before the initiation of new antilymphoma therapy (NALT) were considered. Response assessments were based on revised International Working Group response criteria for malignant lymphoma.	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)
Number of Participants Developing Anti-tafasitamab Antibodies up to Treatment Cycle 12	Anti-tafasitamab antibody samples were defined as negative if they were screened or confirmed negative. Anti-tafasitamab antibody samples were defined as positive if they were positive in both the screening and the confirmatory assays.	up to approximately 1 year (after twelve 28-day cycles)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
B cell numbers	Absolute counts and percentage change from baseline in measurement of B cell numbers in peripheral blood	upto 1 year
T cell numbers	Absolute counts and percentage change from baseline in measurement of T cell numbers in peripheral blood	upto 1 year
NK cell numbers	Absolute counts and percentage change from baseline in measurement of NK cell numbers in peripheral blood	upto 1 year

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Director, Incyte Corporation

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Actual): July 17, 2024
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: monoclonal antibody; CD19; tafasitamab
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Large B-Cell, Diffuse; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Piperidines; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; tafasitamab
• Other Study ID Numbers: MOR208C115; 2023-507993-42-00 (Registry Identifier: EU CT Number); 2021-003855-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No