To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

NCT04661007 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: INCMOR 0208-102
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 23

Brief Summary

This is an open-label, multicenter study to evaluate safety and tolerability, determine the RP2Ds of tafasitamab alone in Japanese participants with R/R NHL, or to evaluate efficacy and safety of tafasitamab in combination with lenalidomide in Japanese participants with R/R DLBCL, or tafasitimab in combination with lenalidomide plus R-CHOP in Japanese participants with previously untreated DLBC, or tafasitimab in combination with lenalidomide in Japanese participants with previously R/R DLBC.

Conditions

Non Hodgkins Lymphoma; Diffuse Large B-cell Lymphoma

Keywords

INCMOR00208; tafasitamab

Outcome Measures

Primary Outcomes (2)

• Part 1,2 and 3 : Treatment Emergent Adverse Events (TEAE'S)

  Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.

  Approximately 2 years

• Part 4: Objective Response

  Best Response of complete/complete metabolic response or partial/partial metabolic response

  Approximately 27 months

Secondary Outcomes (8)

• Part 1,2, 3 and 4 : Cmax of tafasitamab

  Approximately 27 months

• Part 1, 2, 3 and 4: Cmin of tafasitamab

  Approximately 27 months

• Part 4: Complete Response

  Approximately 27 months

• Part 4: Duration of Response

  Approximately 27 months

• Part 4: Progression-Free Survival

  Approximately 27 months

Study Arms (4)

Part 1 : tafasitimab monotherapy

EXPERIMENTAL

Dose-finding to evaluate the safety and tolerability and to determine the RP2Ds of single-agent tafasitamab in Japanese participants with NHL. Part 1 consists of 1 group (Group 1) to evaluate weight-based doses of tafasitamab.

Drug: tafasitamab

Part 2 : tafasitamab combination therapy

EXPERIMENTAL

tafasitamab will be combined with lenalidomide (Group 3) or parsaclisib (Group 4a) in R/R DLBCL participants or lenalidomide plus R-CHOP (Group 5) in previously untreated DLBCL participants. Modified tafasitamab dosing when combined with lenalidomide (Group 2) in participants with R/R DLBCL will be evaluated to determine the recommended clinical dose. The dose of tafasitamab will be based on the weight-based RP2D that is deemed safe and tolerable in Part 1.

Drug: tafasitamab; Drug: lenalidomide; Drug: parsaclisib; Drug: R-CHOP

Part 3 : Dose Expansion of tafasitamab +parsaclisib

EXPERIMENTAL

tafasitamab in combination with parsaclisib will be further evaluated in Group 4b at RP2D determined in Part 2

Drug: tafasitamab; Drug: parsaclisib

Part 4: tafasitamab combination therapy

EXPERIMENTAL

tafasitamiab in combination with lenalidomide will be further evaluated in Group 6 at RP2D determined in Part 2.

Drug: tafasitamab; Drug: lenalidomide

Interventions

tafasitamab DRUG

tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.

Also known as: INCMOR00208, MOR00208, Xmab5574

Part 1 : tafasitimab monotherapy; Part 2 : tafasitamab combination therapy; Part 3 : Dose Expansion of tafasitamab +parsaclisib; Part 4: tafasitamab combination therapy

R-CHOP DRUG

R-CHOP is a combination regimen consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone. R-CHOP will be administered at protocol defined timepoints based on the groups participants are assigned.

Part 2 : tafasitamab combination therapy

lenalidomide DRUG

lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.

Part 2 : tafasitamab combination therapy; Part 4: tafasitamab combination therapy

parsaclisib DRUG

parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.

Part 2 : tafasitamab combination therapy; Part 3 : Dose Expansion of tafasitamab +parsaclisib

Eligibility Criteria

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

You may qualify if:

• Group 1 only: Biopsy-proven participants with relapsed or refractory NHL of DLBCL, FL or MZL.
• Groups 3, 4a and 5 only: Biopsy-proven participants with relapsed or refractory DLBCL.
• Groups 2 and 6 only: Biopsy-proven participants with DLBCL and another select lymphoid neoplasms.
• Participants must have at least 1 bi-dimensionally measurable lesion.
• ECOG performance status of 0 to 2.
• Participants with protocol defined laboratory criteria at screening as defined in the protocol.
• Group 1 only:
• Received at least 1 previous systemic therapy line for the treatment of NHL. At least 1 previous therapy line must have included a CD20-targeted therapy (eg, RTX).
• Groups 2, 3, 4a and 6 only:
• Received at least 1, but no more than 3, previous systemic therapy lines for the treatment of DLBCL. At least 1 previous therapy line must have included a CD20-targeted therapy (eg, RTX).
• Group 5 only: Participants must have:
• Untreated DLBCL.
• Ann Arbor Stage III to IV.
• IPI status of 3 to 5 or age-adjusted IPI 2-3 (in Group 5 only).
• Appropriate candidate for R-CHOP.

You may not qualify if:

• Any other histological type of lymphoma.
• History of prior non-hematologic malignancy.
• Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
• Participants with known positive test result for hepatitis C, and hepatitis B.
• Known seropositive for or history of active viral infection with HIV.
• Known active bacterial, viral, fungal, mycobacterial, or other infection at screening.
• Known CNS lymphoma involvement - present or past medical history.
• 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 participant's ability to give informed consent.
• History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• History or evidence of interstitial lung disease.
• Vaccination with live vaccine within 21 days prior to study treatment (Note: throughout the study treatment period and at least 6 months after end of treatment, vaccination with live vaccines should be avoided).
• Major surgery within up to 30 days prior to signing the ICF, unless the participant is recovered at the time of signing the ICF.
• Any anticancer and/or investigational therapy within 14 days prior to the start of Cycle 1.
• Groups 2, 3, 4a, 5 and 6 only: Gastrointestinal abnormalities including the inability to take oral study treatment, requiring IV alimentation, or prior surgical procedure affecting absorption.
• Pregnancy or lactation.

Sponsors & Collaborators

• Incyte Biosciences Japan GK: lead

Study Sites (23)

Aichi Cancer Center Hospital

Aichi, 464 8681, Japan

Location

Chiba Cancer Center

Chiba, 260-8717, Japan

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

University of Fukui Hospital

Fukui, 910-1193, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Kyushu University Hospital

Fukuoka, Japan

Location

Kobe City Medical Center General Hospital

Hyōgo, 650-0047, Japan

Location

Tokai University Hospital

Kanagawa, 259-1193, Japan

Location

The Cancer Institute Hospital of Jfcr

Kōtoku, 135-8550, Japan

Location

Nho Kumamoto Medical Center

Kumamoto-ken, 860-008, Japan

Location

Nho Shikoku Cancer Center

Matsuyama, 791-0280, Japan

Location

Tohoku University Hospital

Miyagi, 980-8574, Japan

Location

Japanese Red Cross Nagoya Daini Hospital

Nagoya, 466-8650, Japan

Location

Iuhw Narita Hospital

Narita, 286-8520, Japan

Location

Nho Okayama Medical Center

Okayama, 701-1192, Japan

Location

Saitama Medical Center

Saitama-shi, 330-8503, Japan

Location

Nho Hokkaido Cancer Center

Sapporo, 003-0804, Japan

Location

Kindai University Hospital

Sayama, 589-8511, Japan

Location

Osaka University Hospital

Suita-shi, 565-0871, Japan

Location

Nho Disaster Medical Center

Tachikawa, 190-0014, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

Mie University Hospital

Tsu, 514-0001, Japan

Location

Kanagawa Cancer Center

Yokohama, 241-8515, Japan

Location

Related Publications (1)

• Izutsu K, Fukuhara N, Yuda J, Suehiro Y, Kusumoto S, Casadebaig ML, Suzukawa K, Fukushima K. Tafasitamab as Monotherapy or in Combination in Japanese Patients With B-Cell Non-Hodgkin Lymphoma: Results From the Phase 1b J-MIND Study. Cancer Sci. 2026 Jan 21. doi: 10.1111/cas.70306. Online ahead of print.

  PMID: 41563911 DERIVED

Related Links

• To assess the safety and tolerability of tafasitamab alone or in combination with other drugs in Japanese participants with Non-Hodgkins Lymphoma (NHL) (J-MIND)

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse

Interventions

tafasitamab; Lenalidomide; parsaclisib; R-CHOP protocol

Condition Hierarchy (Ancestors)

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

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 9, 2020
• Study Start: December 15, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

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

JP (23)