Clinical Trials

Inclusion Criteria

• Has had diagnosis and prior treatment for atleast one non-hodgkin's lymphoma (NHL) subtype 
  • Mantle cell lymphoma (MCL)
    • Pathologically verified based on local pathology report
    • Relapsed or refractory disease after at least 2 but not more than 5 prior lines of therapy including at least one cycle of ibrutinib therapy 
    • Documented progressive disease during or after ibrutinib treatment or participants who could not tolerate ibrutinib (ie, discontinued ibrutinib due to adverse events 
  • Diffuse large B cell lymphoma (DLBCL)
    • Pathologically confirmed diagnosis of non-transformed DLBCL
    • Relapsed or refractory disease
    • Not considered a candidate for high-dose chemotherapy and autologous stem cell transplantation due to other organ dysfunction or comorbidities (especially pulmonary or cardiac)
  • Follicular lymphoma (FL)
    • Pathologically confirmed Grade 1, 2, or 3a according to World Health Organization (WHO) criteria without pathological evidence of transformation
    • Relapsed disease after at least two prior systemic therapies including one anti-CD20 containing combination regimen
• At least 1 measurable site of disease 
• Expression of CD38 by immunohistochemistry on fresh or archived tumor sample by central assessment
  • Stage 1: participants whose tumors are ≥ 50 % positive for CD38
  • Stage 2: participants whose tumors are ≥ 1 % positive for CD38
• Participant must have an ECOG performance status score of 0 or 1 
• Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or use 2 methods of reliable birth control simultaneously
• A woman of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to Cycle 1 Day 1
• A man who is sexually active with a woman of childbearing potential must agree to always use condom during sexual intercourse and 
• Men must also not donate sperm during the study and for 4 months after receiving the last dose of study drug

Exclusion Criteria

• Known central nervous system lymphoma
• Prior anti-tumor therapy including (all times measured prior to start of study drug)
  • Nitrosoureas within 6 weeks
  • Chemotherapy within 3 weeks
  • Therapeutic antibodies within 4 weeks
  • Radio- or toxin-immunoconjugates within 10 weeks
  • Radiation therapy within 2 weeks,
  • Investigational agents within 3 weeks,
  • Antibody within 4 weeks 
• Daratumumab or other anti-CD38 therapies
• Participant has a history of malignancy (other than NHL) within 5 years before the screening period; exceptions are
  • Squamous and basal cell carcinomas of the skin 
  • Carcinoma in situ of the cervix
  • Non-muscle invasive bladder cancer (papillary neoplasms of low malignant potential and primary non-invasive tumors)
  • Malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
• Participant has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) < 50% predicted normal
  • FEV1 testing is required for patients suspected of having COPD and participants must be excluded if FEV1 < 50 % 
• Participant has known moderate or severe persistent asthma within 2 years or currently has uncontrolled asthma of any classification
  • Participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study