To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)
NCT ID: NCT04661007
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
72 participants
INTERVENTIONAL
2020-12-15
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1 : tafasitimab monotherapy
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.
tafasitamab
tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
Part 2 : tafasitamab combination therapy
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.
tafasitamab
tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
lenalidomide
lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.
parsaclisib
parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.
R-CHOP
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 3 : Dose Expansion of tafasitamab +parsaclisib
tafasitamab in combination with parsaclisib will be further evaluated in Group 4b at RP2D determined in Part 2
tafasitamab
tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
parsaclisib
parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.
Part 4: tafasitamab combination therapy
tafasitamiab in combination with lenalidomide will be further evaluated in Group 6 at RP2D determined in Part 2.
tafasitamab
tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
lenalidomide
lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.
Interventions
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tafasitamab
tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
lenalidomide
lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.
parsaclisib
parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.
R-CHOP
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. Untreated DLBCL.
2. Ann Arbor Stage III to IV.
3. IPI status of 3 to 5 or age-adjusted IPI 2-3 (in Group 5 only).
4. Appropriate candidate for R-CHOP.
5. LVEF of ≥ 50%, assessed by echocardiography.
* Willingness to avoid pregnancy or fathering children.
* In the opinion of investigator, the participant must:
1. Not have a history of noncompliance in relation to medical regimens or be considered potentially unreliable and/or uncooperative.
2. Be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.
Exclusion Criteria
* 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.
* Groups 2, 3, 5 and 6 only: Participants who have history of deep venous thrombosis/embolism, threatening thromboembolism, stroke or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period if required
* Group 4a only: Use or expected use during the study of any restricted medications, including potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the date of study treatment administration
* Groups 1, 3, 4a and 6 only: Participants who have:
1. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy, or other lymphoma-specific therapy within the 14 days prior to Day 1 dosing.
2. In the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies.
3. Groups 1, 3 and 4a only: Previous treatment with CD19-targeted therapy (eg, CD19-CAR-T therapies, other CD19 mAbs including bispecific and ADCs).
Groups 2 and 6 only: Previous treatment with tafasitamab. Note: Participants in Groups 2 and 6 who have received previous CD19 directed therapy (other than tafasitamab) must have CD19-positive lymphoma confirmed by a biopsy taken after completing the prior CD19-targeted therapy.
4. Groups 2, 3 and 6 only: Been previously treated with IMiDs (eg, thalidomide or LEN).
5. Group 4a only: Been previously treated with selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib) and/or Bruton's tyrosine kinase inhibitors (eg, ibrutinib).
6. A history of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, IMiDs, and/or the excipients contained in the study treatment formulations (citric acid monohydrate, polysorbate 20, sodium citrate dehydrate and trehalose dihydrate).
7. Undergone ASCT within the period ≤ 3 months before the signing of the ICF. Participants who have a more distant history of ASCT must exhibit full hematological recovery before enrolment into the study.
8. Undergone previous allogenic stem cell transplantation.
9. Concurrent treatment other anticancer or experimental treatments.
* Group 5 only: Participants who have:
1. A history of radiation therapy to ≥ 25% of the bone marrow for other diseases or history of anthracycline therapy.
2. A history of hypersensitivity or contraindication to any component of R-CHOP, LEN, or compounds of similar biological or chemical composition as tafasitamab and/or the excipients contained in the study treatment formulations or R-CHOP.
3. Contraindication to any of the individual components of R-CHOP.
4. Any anticancer and/or investigational therapy within 30 days prior to the start of Cycle 1, except for permitted prephase treatment defined below.
18 Years
ALL
No
Sponsors
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Incyte Biosciences Japan GK
INDUSTRY
Responsible Party
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Locations
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Aichi Cancer Center Hospital
Aichi, , Japan
Chiba Cancer Center
Chiba, , Japan
National Cancer Center Hospital East
Chiba, , Japan
University of Fukui Hospital
Fukui, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Kobe City Medical Center General Hospital
Hyōgo, , Japan
Tokai University Hospital
Kanagawa, , Japan
The Cancer Institute Hospital of Jfcr
Kōtoku, , Japan
Nho Kumamoto Medical Center
Kumamoto-ken, , Japan
Nho Shikoku Cancer Center
Matsuyama, , Japan
Tohoku University Hospital
Miyagi, , Japan
Japanese Red Cross Nagoya Daini Hospital
Nagoya, , Japan
Iuhw Narita Hospital
Narita, , Japan
Nho Okayama Medical Center
Okayama, , Japan
Saitama Medical Center
Saitama-shi, , Japan
Nho Hokkaido Cancer Center
Sapporo, , Japan
Kindai University Hospital
Sayama, , Japan
Osaka University Hospital
Suita-shi, , Japan
Nho Disaster Medical Center
Tachikawa, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Mie University Hospital
Tsu, , Japan
Kanagawa Cancer Center
Yokohama, , Japan
Countries
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Related Links
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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)
Other Identifiers
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INCMOR 0208-102
Identifier Type: -
Identifier Source: org_study_id