Outpatient Epcoritamab as 2L in NTE R/R DLBCL

Exclusion Criteria

• •Age ≥18 years.
• •ECOG performance status 0-2.
• •Not a candidate for high dose chemotherapy and autologous stem cell transplant per the treating investigator, or patient refusal of high dose chemotherapy and autologous transplant.
• •Participants must meet the following organ and marrow function as defined below:
• •* absolute neutrophil count ≥1,000/mcL (Growth factor support is permitted)
• •* platelets ≥75,000/mcL (\>50,000 in the presence of bone marrow involvement or splenomegaly; platelet transfusions are permitted)
• •* Hemoglobin ≥8 g/dL (\>7 g/dL in the presence of bone marrow involvement; blood transfusions are permitted)
• •Participants must have adequate organ function as defined below (unless abnormalities are considered related to target organ involvement or compression by lymphoma):
• •* total bilirubin ≤ 1.5x institutional upper limit of normal (ULN) (Isolated bilirubin ≤3.0x ULN is acceptable if considered secondary to Gilbert's syndrome)
• •* AST(SGOT) and ALT(SGPT) ≤3.0x institutional ULN
• •* Creatinine clearance ≥45 mL/min eGFR (Cockcroft-Gault or MDRD equation)
• •* PT within institutional normal range (unless on anticoagulation expected to affect PT, in which case PT cut off does not apply)
• •* PTT within institutional normal range (unless on anticoagulation expected to affect PTT, in which case PTT cut off does not apply)
• •Ability to remain within 60 minutes of the administration site for 24 hours following cycle 1 day 15 dose of study drug.
• •The effects of epcoritamab on the developing human fetus are unknown. Women of child-bearing potential must agree to use adequate contraception starting with the first dose of study drug, for the duration of study participation, and for at least 6 months after the last dose of study intervention. Women must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Adequate contraception methods:
• •* Male Partner Sterilization: When the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate.
• •* Use of a combination of any two of the following (one from "a" and one from "b"):
• •1. Placement of an intrauterine device (IUD) or intrauterine system or established use of oral, injected, or implanted hormonal methods of contraception
• •2. Barrier methods of contraception: Male Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
• •True abstinence, defined as refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject.
• •Nonchildbearing potential is defined as follows:
• •* ≥45 years of age and has not had menses for at least 12 consecutive months.
• •* Subjects who have been amenorrhoeic for \<1 year must have, on at least two occasions prior to first dose of study drug, a follicle stimulating hormone value greater than 40 IU/L; historical follicle stimulating hormone values are eligible
• •* Post-bilateral oophorectomy (with or without hysterectomy) or post-tubal ligation at least six weeks prior to first dose of study drug. Documented oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure. In the case of oophorectomy alone, reproductive status must be confirmed by follicle stimulating hormone level assessment as above.
• •Women of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test at screening.
• •Fertile men, defined as all males physiologically capable of conceiving offspring who are sexually active with a female partner of childbearing potential, must agree to use adequate contraception starting with the first dose of study drug, for the duration of study participation, and 3 months after completion of administration. Men must also agree not to donate sperm during this period. Men may agree to remain abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term or persistent basis) OR agree to use a male condom, and their female partner must use an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse if they are a WOCBP (including pregnant females).
• •Ability to understand and the willingness to sign a written informed consent document by the participant or a legally authorized representative.
• •Participant must not have used an investigational drug or approved systemic lymphoma therapy within 28 days preceding the first dose of study drug. Steroids for lymphoma disease control are permitted but must be stopped at least 7 days prior to the first dose of study drug.
• •Participants must not have received prior CD20/CD3 bispecific antibody.
• •Participants must not have received prior autologous or allogeneic stem cell transplant.
• •Participants must not have received prior anti-CD19 CAR T-cell therapy.