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 (Jun 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
Treatments studied
Immunotherapy
Cancer type
Non-Hodgkin Lymphoma
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.
Frequently asked questions
Is NCT05891821 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic cytotoxic chemotherapy, biological therapy or investigational therapy, small molecule/tyrosine kinase inhibitors disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages