Non Hodgkins LymphomaPhase 1/2J-MINDNCT04661007
To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)
A Phase 1/2 study testing tafasitamab, lenalidomide and parsaclisib in people with Non Hodgkins Lymphoma and Diffuse Large B-cell Lymphoma, run by Incyte Biosciences Japan GK at 23 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkins Lymphoma, Diffuse Large B-cell Lymphoma
- What is being tested?
- tafasitamab, lenalidomide and parsaclisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 23 sitesJapan
- Study dates
- 15 Dec 2020to 31 Dec 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- LVEF of ≥ 50%, assessed by echocardiography.
- Willingness to avoid pregnancy or fathering children.
- In the opinion of investigator, the participant must:
- Not have a history of noncompliance in relation to medical regimens or be considered potentially unreliable and/or uncooperative.
- 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.
Who cannot join
- 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.
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- 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:
- Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy, or other lymphoma-specific therapy within the 14 days prior to Day 1 dosing.
- In the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies.
- 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.
- Groups 2, 3 and 6 only: Been previously treated with IMiDs (eg, thalidomide or LEN).
- 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).
- 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).
- 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.
- Undergone previous allogenic stem cell transplantation.
- Concurrent treatment other anticancer or experimental treatments.
- Group 5 only: Participants who have:
- A history of radiation therapy to ≥ 25% of the bone marrow for other diseases or history of anthracycline therapy.
- 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.
- Contraindication to any of the individual components of R-CHOP.
- Any anticancer and/or investigational therapy within 30 days prior to the start of Cycle 1, except for permitted prephase treatment defined below.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Japan23 sites
Aichi Cancer Center Hospital
Aichi, 464 8681
Chiba Cancer Center
Chiba, 260-8717
National Cancer Center Hospital East
Chiba, 277-8577
University of Fukui Hospital
Fukui, 910-1193
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Kyushu University Hospital
Fukuoka
Kobe City Medical Center General Hospital
Hyōgo, 650-0047
Tokai University Hospital
Kanagawa, 259-1193
The Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550
Nho Kumamoto Medical Center
Kumamoto-ken, 860-008
Nho Shikoku Cancer Center
Matsuyama, 791-0280
Tohoku University Hospital
Miyagi, 980-8574
Japanese Red Cross Nagoya Daini Hospital
Nagoya, 466-8650
Iuhw Narita Hospital
Narita, 286-8520
Nho Okayama Medical Center
Okayama, 701-1192
Saitama Medical Center
Saitama-shi, 330-8503
Nho Hokkaido Cancer Center
Sapporo, 003-0804
Kindai University Hospital
Sayama, 589-8511
Osaka University Hospital
Suita-shi, 565-0871
Nho Disaster Medical Center
Tachikawa, 190-0014
National Cancer Center Hospital
Tokyo, 104-0045
Mie University Hospital
Tsu, 514-0001
Kanagawa Cancer Center
Yokohama, 241-8515
About this study
Official title: A Phase 1b/2 Study of Tafasitamab, Tafasitamab Plus Lenalidomide, Tafasitamab Plus Parsaclisib, and Tafasitamab Plus Lenalidomide in Combination With R-CHOP in Japanese Participants With Non-Hodgkin Lymphoma
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.
- Being tested
- tafasitamab, lenalidomide, parsaclisib, R-CHOP
- Keywords
- INCMOR00208, tafasitamab
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tafasitamabDrug
Also called INCMOR00208, MOR00208, Xmab5574
tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
lenalidomideDrug
lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.
parsaclisibDrug
parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.
R-CHOPDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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. Receives: Drug: tafasitamab; Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1, Parts 1 and 2; Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any new AE/worsening of an event from the first dose to 90 days (30 days until Amendment 3) after the last dose.
Measured: up to 1066 days
Phase 1, Parts 1 and 2; Number of Participants With Any ≥Grade 3 TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. A TEAE was defined as any new AE/worsening of an event from the first dose to 90 days (30 days until Amendment 3) after the last dose. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. 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 treatment indicated. Grade 5: fatal.
Measured: up to 1066 days
Phase 1, Part 1 and Part 2 (Groups 3, 4a, and 5); Number of Participants With Any Dose-limiting Toxicity (DLT)
A DLT was defined as the occurrence of any protocol-defined toxicity occurring up to and including Day 28 (Day 21 in Group 5 only), except those with a clear alternative explanation.
Measured: up to 28 days
Phase 2, Part 4: Objective Response (OR) as Determined by an Independent Review Committee (IRC) According to Lugano Criteria
OR=percentage of participants with a complete response/complete metabolic response (CR/CMR) or partial response/partial metabolic response (PR/PMR). CR: (1) target nodes/nodal masses of lymph nodes/extralymphatic sites regressed to ≤1.5 centimeters (cm) in the longest dimension transverse diameter of lesion (LDi); (2) absence of non-measured lesions; (3) organ enlargement regressed to normal; (4) no new lesions; (5) normal bone marrow morphology; if indeterminate, immunohistochemistry negative. PR: (1) lymph nodes/extralymphatic sites: ≥50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes/extranodal sites; (2) absent/regressed non-measured lesions, no increase; (3) organ enlargement; spleen regressed by >50% in length beyond normal; (4) no new lesions.
Measured: up to 723 days
Secondary outcomes (16)
Phase 1, Parts 1 and 2; Cmax of Tafasitamab
Cmax was defined as the maximum observed plasma concentration of tafasitamab. Samples were collected as follows: Groups 1, 3, and 4a: Cycle 1 Day 1, preinfusion, immediately after tafasitamab infusion, 1 and 4 hours post-infusion (PI). Cycle 1 Day 2, 24 hours PI on Day 1. Cycle 1 Days 4, 8, 15, and 22, preinfusion; 1 hour PI. Cycles 2 and 3 Days 1, 22, preinfusion and 1 hour PI. Cycle 4 and beyond every 4 cycles (8, 12, etc.) Day 1, preinfusion. Safety follow-up/end of study visit, untimed sample. Group 2: Cycle 1 Days 1, 4, 8, and 15, preinfusion, 30 min PI. Cycles 2 and 3 Days 1 and 15, preinfusion and 30 min PI. Cycle 4-12 (every other cycle, i.e., Cycle 4, 6, 8, 12) Day 1, preinfusion and 30 min PI. Cycle 12 Day 28 and end of treatment, untimed sample. Group 5: Cycle 1 Day 1, preinfusion, immediately after tafasitamab infusion, 1 and 4 hours PI. Cycle 1 Day 2, 24 hours PI on Day 1. Cycle 1 Days 8 and 15, preinfusion and 1 hour PI. Cycles 2 and 3-6 Day 1, preinfusion and 1 hour PI.
Measured: Cycle 1 Days 1, 4, 8, 15, 22; Cycles 2 and 3 Days 1 and 22; Cycle 4 and every 4 cycles thereafter (Cycles 8, 12, etc.) Day 1; End of Treatment
Phase 1, Parts 1 and 2; Cmin of Tafasitamab
Cmin was defined as the minimum observed plasma concentration of tafasitamab. Samples were collected as follows: Groups 1, 3, and 4a: Cycle 1 Day 1, preinfusion, immediately after tafasitamab infusion, 1 and 4 hours post-infusion (PI). Cycle 1 Day 2, 24 hours PI on Day 1. Cycle 1 Days 4, 8, 15, and 22, preinfusion; 1 hour PI. Cycles 2 and 3 Days 1, 22, preinfusion and 1 hour PI. Cycle 4 and beyond every 4 cycles (8, 12, etc.) Day 1, preinfusion. Safety follow-up/end of study visit, untimed sample. Group 2: Cycle 1 Days 1, 4, 8, and 15, preinfusion, 30 min PI. Cycles 2 and 3 Days 1 and 15, preinfusion and 30 min PI. Cycle 4-12 (every other cycle, i.e., Cycle 4, 6, 8, 12) Day 1, preinfusion and 30 min PI. Cycle 12 Day 28 and end of treatment, untimed sample. Group 5: Cycle 1 Day 1, preinfusion, immediately after tafasitamab infusion, 1 and 4 hours PI. Cycle 1 Day 2, 24 hours PI on Day 1. Cycle 1 Days 8 and 15, preinfusion and 1 hour PI. Cycles 2 and 3-6 Day 1, preinfusion and 1 hour PI.
Measured: Cycle 1 Days 1, 4, 8, 15, 22; Cycles 2 and 3 Days 1 and 22; Cycle 4 and every 4 cycles thereafter (Cycles 8, 12, etc.) Day 1; End of Treatment
Phase 2, Part 4; Cmax of Tafasitamab
Cmax was defined as the maximum observed plasma concentration of tafasitamab.
Measured: Cycle 1 Days 1, 4, and 15, preinfusion and 1 hour post-infusion. Cycles 2 and 3 Days 1 and 15, preinfusion and 1 hour post-infusion. Cycle 4 and every 4 cycles thereafter (Cycles 8, 12, etc.) Day 1, preinfusion. End of treatment, untimed sample
Phase 2, Part 4; Cmin of Tafasitamab
Cmin was defined as the minimum observed plasma concentration of tafasitamab.
Measured: Cycle 1 Days 1, 4, and 15, preinfusion and 1 hour post-infusion. Cycles 2 and 3 Days 1 and 15, preinfusion and 1 hour post-infusion. Cycle 4 and every 4 cycles thereafter (Cycles 8, 12, etc.) Day 1, preinfusion. End of treatment, untimed sample
Phase 1, Part 2: Percentage of Participants With the Indicated Response Per Investigator Assessment of Response According to the Lugano Criteria
CR: (1) target nodes/nodal masses of lymph nodes/extralymphatic sites regressed to ≤1.5 cm in the longest dimension transverse diameter of lesion (LDi); (2) absence of non-measured lesions; (3) organ enlargement regressed to normal; (4) no new lesions; (5) normal bone marrow morphology; if indeterminate, immunohistochemistry negative. PR: (1) lymph nodes/extralymphatic sites: ≥50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes/extranodal sites; (2) absent/regressed non-measured lesions, no increase; (3) organ enlargement; spleen regressed by >50% in length beyond normal; (4) no new lesions.
Measured: up to approximately 6 years
Phase 1, Part 2: Percent Reduction in the Sum of the Products of Perpendicular Diameters for Multiple Lesions in up to 6 Target Measurable Nodes/Extranodal Sites Assessed by Computed Tomography as Per Investigator Assessment of Lugano Criteria Response
The sum of the products of the longest perpendicular diameters (SPD) was calculated by summing the products of the two longest perpendicular diameters for each target lesion or any extranodal lesion. Percent reduction in SPD from baseline in up to 6 target measurable nodes and extranodal sites assessed by computed tomography as per investigator assessment of response according to the Lugano criteria was calculated per assessment, and the highest reduction was analyzed.
Measured: up to approximately 6 years
Phase 2, Part 4: Complete Response (CR) as Determined by an IRC According to Lugano Criteria
CR: (1) target nodes/nodal masses of lymph nodes/extralymphatic sites regressed to ≤1.5 cm in the longest dimension transverse diameter of lesion (LDi); (2) absence of non-measured lesions; (3) organ enlargement regressed to normal; (4) no new lesions; (5) normal bone marrow morphology; if indeterminate, immunohistochemistry negative.
Measured: up to approximately 6 years
Phase 2, Part 4: Kaplan-Meier Estimate of Duration of Response (DOR) as Determined by an IRC According to Lugano Criteria
DOR was defined as the time from the first documented CR/CMR or PR/PMR as determined by an IRC according to the Lugano criteria until the date of the first documented disease progression or death due to any cause, whichever occurred first. CR: (1) target nodes/nodal masses of lymph nodes/extralymphatic sites regressed to ≤1.5 cm in the longest dimension transverse diameter of lesion (LDi); (2) absence of non-measured lesions; (3) organ enlargement regressed to normal; (4) no new lesions; (5) normal bone marrow morphology; if indeterminate, immunohistochemistry negative. PR: (1) lymph nodes/extralymphatic sites: ≥50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes/extranodal sites; (2) absent/regressed non-measured lesions, no increase; (3) organ enlargement; spleen regressed by >50% in length beyond normal; (4) no new lesions.
Measured: up to approximately 6 years
Phase 2, Part 4: Kaplan-Meier Estimate of Progression-free Survival (PFS) as Determined by an IRC
PFS was defined as the time from the date of the first dose of study treatment until the first documented disease progression as determined by an IRC according to the Lugano criteria or death due to any cause, whichever occurred first. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Measured: up to approximately 6 years
Phase 2, Part 4: Kaplan-Meier Estimate of Overall Survival
Overall survival was defined as defined as the time from the first dose of study treatment until death due to any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Measured: up to approximately 6 years
Phase 2, Part 4: OR as as Per Investigator Assessment of Response According to the Lugano Criteria
OR=percentage of participants with a CR/CMR or PR/PMR. CR: (1) target nodes/nodal masses of lymph nodes/extralymphatic sites regressed to ≤1.5 cm in the longest dimension transverse diameter of lesion (LDi); (2) absence of non-measured lesions; (3) organ enlargement regressed to normal; (4) no new lesions; (5) normal bone marrow morphology; if indeterminate, immunohistochemistry negative. PR: (1) lymph nodes/extralymphatic sites: ≥50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes/extranodal sites; (2) absent/regressed non-measured lesions, no increase; (3) organ enlargement; spleen regressed by >50% in length beyond normal; (4) no new lesions.
Measured: up to approximately 6 years
Phase 2, Part 4: CR as Per Investigator Assessment of Response According to the Lugano Criteria
CR: (1) target nodes/nodal masses of lymph nodes/extralymphatic sites regressed to ≤1.5 cm in the longest dimension transverse diameter of lesion (LDi); (2) absence of non-measured lesions; (3) organ enlargement regressed to normal; (4) no new lesions; (5) normal bone marrow morphology; if indeterminate, immunohistochemistry negative.
Measured: up to approximately 6 years
Phase 2, Part 4: DOR as Per Investigator Assessment of Response According to the Lugano Criteria
DOR was defined as the time from the first documented CR/CMR or PR/PMR as determined by an IRC according to the Lugano criteria until the date of the first documented disease progression or death due to any cause, whichever occurred first. CR: (1) target nodes/nodal masses of lymph nodes/extralymphatic sites regressed to ≤1.5 cm in the longest dimension transverse diameter of lesion (LDi); (2) absence of non-measured lesions; (3) organ enlargement regressed to normal; (4) no new lesions; (5) normal bone marrow morphology; if indeterminate, immunohistochemistry negative. PR: (1) lymph nodes/extralymphatic sites: ≥50% decrease in the sum of the product of perpendicular diameters for multiple lesions of up to 6 target measurable nodes/extranodal sites; (2) absent/regressed non-measured lesions, no increase; (3) organ enlargement; spleen regressed by >50% in length beyond normal; (4) no new lesions.
Measured: up to approximately 6 years
Phase 2, Part 4: PFS as Per Investigator Assessment of Response According to the Lugano Criteria
PFS was defined as the time from the date of the first dose of study treatment until the first documented disease progression as determined by an IRC according to the Lugano criteria or death due to any cause, whichever occurred first.
Measured: up to approximately 6 years
Phase 2, Part 4: Number of Participants With Any TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any new AE/worsening of an event from the first dose to 90 days (30 days until Amendment 3) after the last dose.
Measured: up to approximately 6 years
Phase 2, Part 4: Number of Participants With Any ≥Grade 3 TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. A TEAE was defined as any new AE/worsening of an event from the first dose to 90 days (30 days until Amendment 3) after the last dose. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. 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 treatment indicated. Grade 5: fatal.
Measured: up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start15 Dec 2020
- Primary completion1 Jul 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Hodgkins LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Biosciences Japan GK
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661007
- Sponsor's protocol ID
- INCMOR 0208-102
- Acronym
- J-MIND
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2020
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Publications
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 Apr;117(4):1093-1105. doi: 10.1111/cas.70306. Epub 2026 Jan 21.
PubMed 41563911