Actively Recruiting
Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001)
Led by Immune Oncology Research Institute · Updated on 2025-05-08
20
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
I
Immune Oncology Research Institute
Lead Sponsor
A
Agenus Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate by giving written informed consent
- 18 years of age or older
- Histologically confirmed diagnosis of relapsed/refractory classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma
- No available standard therapy or failure of standard therapy or lack of access to standard therapy
- Life expectancy of at least 3 months and ECOG performance status of 1 or less
- Sufficient formalin-fixed tumor tissue sample available (not older than 3 years) or willing to undergo fresh biopsy from a non-irradiated site
- Adequate organ function with specified laboratory values within 7 days before first dose
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for 90 days after treatment
- Male patients with female partners of childbearing potential must agree to use effective contraception during and for 90 days after treatment
- Willing and able to comply with study requirements
You will not qualify if you...
- Received systemic cytotoxic chemotherapy within 3 weeks before study treatment
- Received biological or investigational therapy within 4 weeks or 5 half-lives, whichever is shorter
- Received small molecule/tyrosine kinase inhibitors within 2 weeks or 5 half-lives, whichever is shorter
- Received radiation therapy within 3 weeks before study treatment (except palliative radiation received 2 weeks prior)
- Had major surgery within 4 weeks before study treatment
- Disease progression after prior therapy targeting PD-1 or PD-L1
- Persisting adverse events from prior immunotherapy of grade 2 or higher
- Expected to require other systemic or localized antineoplastic therapy during study
- Known allergy or hypersensitivity to balstilimab or uncontrolled asthma
- Active or recent autoimmune disease requiring systemic treatment within 2 years
- Use of systemic corticosteroids (>10 mg prednisone equivalent daily) within 14 days or other immunosuppressive medication within 30 days before treatment
- History of allogeneic tissue or solid organ transplant
- Active significant cardiovascular disease within 6 months
- QTc interval corrected > 480 ms
- Current or prior interstitial lung disease or pneumonitis requiring glucocorticoids
- Untreated hepatitis B or C or tuberculosis
- Uncontrolled HIV infection
- Other systemic conditions or organ abnormalities interfering with study
- Psychiatric or substance use disorders interfering with study participation
- Legally incapacitated or limited legal capacity
- Pregnant or breastfeeding
- Received live or attenuated vaccine within 14 days or other vaccines within 48 hours before treatment
- Other comorbidities or therapies altering risk-benefit of balstilimab as determined by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hematology Center named after prof. R. Yeolyan
Yerevan, Armenia, 0014
Actively Recruiting
Research Team
A
Astghik Voskanyan, MD
CONTACT
S
Samvel Bardakhchyan, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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