Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT04045028
Eligibility Criteria:
Inclusion Criteria:
General Inclusion Criteria (All Participants):
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of \>/= 12 weeks
Inclusion Criteria Specific to Arms A, C and E (R/R MM):
* Arm A only: Must have R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
* Arms C and E only: Participants with R/R MM who have received at least 3 prior lines of therapy.
* Measurable disease defined by laboratory test results.
Inclusion Criteria Specific to Arms B and D (R/R NHL):
* Participants with histologically confirmed B-cell NHL who have relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists.
* Must have at least one bi-dimensionally measurable lesion.
Exclusion Criteria:
General Exclusion Criteria (All Participants):
* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, hormonal therapy, and/or radiotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment
* Prior treatment with any anti-TIGIT agent
* Prior treatment with chimeric antigen receptor-T (CAR-T) therapy within 12 weeks before first study drug administration
* Autologous Stem-Cell Transplantation (ASCT) within 100 days prior to first study drug administration
* Active or history of autoimmune disease or immune deficiency
* Known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection within 4 weeks prior to first study drug administration
Exclusion Criteria Specific to Arms A, C and E (R/R MM):
* Primary or secondary plasma cell leukemia
* Current or history of CNS involvement by MM
Exclusion Criteria Specific to Arms B and D (R/R NHL):
* Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
* Current or history of CNS lymphoma
* Current eligibility for ASCT
Other protocol defined inclusion/exclusion criteria could apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04045028
Study Brief:
Protocol Section:
NCT04045028