Evaluating Tafasitamab for Non-Hodgkins Lymphoma in Japanese Patients

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 study is testing a new treatment called tafasitamab, alone and with other drugs, to see how safe and effective it is for Japanese patients with relapsed or hard-to-treat Non-Hodgkin's Lymphoma.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Incyte Corporation (Industry-sponsored)
• Drugs / interventions: tafasitamab, ibrutinib, CAR-T, chemotherapy, radiation, tafasitimab
• Locations: 23 sites (Aichi and 22 other locations)
• Trial ID: NCT04661007 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter study aims to assess the safety and tolerability of tafasitamab, both alone and in combination with other treatments, in Japanese participants with relapsed or refractory Non-Hodgkins Lymphoma (NHL). The study will determine the recommended phase 2 doses (RP2Ds) of tafasitamab and evaluate its efficacy when combined with lenalidomide and R-CHOP in various patient groups. Participants must have measurable lesions and meet specific criteria regarding previous treatments and performance status.

Who should consider this trial

Good fit: Ideal candidates include Japanese patients with biopsy-proven relapsed or refractory Non-Hodgkins Lymphoma, particularly those who have received prior systemic therapies.

Not a fit: Patients with untreated Non-Hodgkins Lymphoma who do not meet the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for Japanese patients with Non-Hodgkins Lymphoma.

How similar studies have performed: Other studies have shown promising results with tafasitamab and similar approaches in treating Non-Hodgkins Lymphoma, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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:

  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:

* 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.
* 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.

Where this trial is running

Aichi and 22 other locations

• Aichi Cancer Center Hospital — Aichi, Japan (Recruiting)
• Chiba Cancer Center — Chiba, Japan (Recruiting)
• National Cancer Center Hospital East — Chiba, Japan (Recruiting)
• University of Fukui Hospital — Fukui, Japan (Recruiting)
• National Hospital Organization Kyushu Cancer Center — Fukuoka, Japan (Recruiting)
• Kyushu University Hospital — Fukuoka, Japan (Recruiting)
• Kobe City Medical Center General Hospital — Hyogo, Japan (Recruiting)
• Tokai University Hospital — Kanagawa, Japan (Recruiting)
• The Cancer Institute Hospital of Jfcr — Koto-ku, Japan (Recruiting)
• Nho Kumamoto Medical Center — Kumamoto-ken, Japan (Recruiting)
• Nho Shikoku Cancer Center — Matsuyama, Japan (Recruiting)
• Tohoku University Hospital — Miyagi, Japan (Recruiting)
• Japanese Red Cross Nagoya Daini Hospital — Nagoya, Japan (Recruiting)
• Iuhw Narita Hospital — Narita City, Japan (Not_yet_recruiting)
• Nho Okayama Medical Center — Okayama, Japan (Recruiting)
• Kindai University Hospital — Osakasayama City, Japan (Recruiting)
• Saitama Medical Center — Saitama-shi, Japan (Recruiting)
• Nho Hokkaido Cancer Center — Sapporo, Japan (Recruiting)
• Osaka University Hospital — Suita-shi, Japan (Recruiting)
• Nho Disaster Medical Center — Tachikawa, Japan (Recruiting)
• National Cancer Center Hospital — Tokyo, Japan (Recruiting)
• Mie University Hospital — Tsu, Japan (Recruiting)
• Kanagawa Cancer Center — Yokohama-shi, Japan (Recruiting)

Study contacts

• Study coordinator: Incyte Biosciences Japan GK Development Operations Call Center

Conditions Non Hodgkins Lymphoma; Diffuse Large B-cell Lymphoma; INCMOR00208; tafasitamab