This is an open-label, multicenter study to evaluate safety and tolerability, determine the
RP2Ds of tafasitamab anlone in Japanese participants with NHL., or tafasitimab in combination
with lenalidomide in in Japanese participants with R/R DLBCL, or tafasitimab in combination
with parsaclisib in in Japanese participants with R/R DLBCL or tafasitimab in combination
with lenalidomide plus R-CHOP in Japanese participants with previously untreated DLBCL.
- Groups 1 and 2 only: Biopsy-proven participants with relapsed or refractory NHL of
DLBCL, FL or MZL..
- Groups 3, and 4 only: Biopsy-proven participants with relapsed or refractory DLBCL..
- Groups 5 only: Biopsy-proven participants with relapsed or refractory DLBCL..
- 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
- Groups 1 and 2 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 3, 4a, and 4b 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: Participant must have: a. Untreated DLBCL. b. Ann Arbor Stage III to IV. c.
IPI status of 3 to 5 or age-adjusted IPI 2-3 (in Group 5 only). d. Appropriate candidate
for R-CHOP. e. LVEF of ≥ 50%, assessed by echocardiography.
-Willingness to avoid pregnancy or fathering children.
-In the opinion of investigator, the participant must: a. Not have a history of
noncompliance in relation to medical regimens or be considered potentially unreliable
b. 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.
-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
- Gastrointestinal abnormalities including the inability to take oral study treatment,
requiring IV alimentation, or prior surgical procedure affecting absorption.
- Pregnancy or lactation.
- Groups 3 and 5 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
- Groups 4a and 4b 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, 2, 3, 4a, and 4b only: Participants who have: a. Not discontinued
CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy,
or other lymphoma-specific therapy within the 14 days prior to Day 1 dosing.
b. In the opinion of the investigator, not recovered sufficiently from the adverse
toxic effects of prior therapies.
c. Previous treatment with CD19-targeted therapy (eg, CD19-CAR-T therapies, other CD19
mAbs including bispecific and ADCs).
d. Group 3 only: Been previously treated with IMiDs (eg, thalidomide or LEN). e. Group
4a and 4b only: Been previously treated with selective PI3Kδ or pan-PI3K inhibitors
(eg, idelalisib, copanlisib, duvelisib) and/or Bruton's tyrosine kinase inhibitors
f. 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).
g. 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.
h. Undergone previous allogenic stem cell transplantation. i. Concurrent treatment
other anticancer or experimental treatments.
- Group 5 only: Participants who have: a. A history of radiation therapy to ≥ 25% of the
bone marrow for other diseases or history of anthracycline therapy.
b. 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.
c. Contraindication to any of the individual components of R-CHOP. d. Any anticancer
and/or investigational therapy within 30 days prior to the start of Cycle 1, except
for permitted prephase treatment defined below.