OncoMatch/Clinical Trials/NCT05891821
Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001)
Is NCT05891821 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Balstilimab for lymphoma.
Treatment: Balstilimab — The goal of this study is to see if the drug balstilimab is safe and effective in participants with relapsed/refractory lymphomas. Participants will receive balstilimab every 3 weeks and their outcomes will be assessed periodically.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic cytotoxic chemotherapy
Received systemic cytotoxic chemotherapy within 3 weeks before initiation of study treatment
Cannot have received: biological therapy or investigational therapy
Received biological therapy or investigational therapy within 4 weeks or 5 circulating halve-lives, whichever is shorter
Cannot have received: small molecule/tyrosine kinase inhibitors
Received small molecule/tyrosine kinase inhibitors within 2 weeks or 5 circulating half-lives, whichever is shorter
Cannot have received: radiation therapy
Exception: palliative radiation therapy can be received 2 weeks prior to initiation of study treatment
Received radiation therapy within 3 weeks before initiation of study treatment, except for palliative radiation therapy, which can be received 2 weeks prior to initiation of study treatment
Cannot have received: major surgery
Had major surgery within 4 weeks before initiation of study treatment
Cannot have received: antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1 and anti-PD-L1 antibodies
Has gone through disease progression after receiving prior therapy with: Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1 and anti-PD-L1 antibodies
Lab requirements
Blood counts
Neutrophils ≥ 1500/μL (Must be stable and off any growth factor within 4 weeks of first study treatment administration); Platelets ≥ 75 × 10^3/μL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration); Hemoglobin ≥ 8.0 g/dL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration)
Kidney function
Creatinine clearance ≥ 30 mL/min as measured or calculated per local institutional standards
Liver function
AST/ALT ≤ 3 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of ≤ 3.0 × ULN)
Cardiac function
QTcF (QTc interval corrected using Fridericia's formula) of > 480 ms excluded; Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication
Has adequate organ function defined as the following laboratory values within 7 days of C1D1: Neutrophils ≥ 1500/μL...Creatinine clearance ≥ 30 mL/min...AST/ALT ≤ 3 × ULN...Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of ≤ 3.0 × ULN); QTcF (QTc interval corrected using Fridericia's formula) of > 480 ms excluded; Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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