Phase 2 Lymphoma Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing to take part and give written consent to participate
• People who are 18 years of age or older
• People who have a confirmed diagnosis of relapsed or returned/treatment-resistant classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma, where standard treatments have failed, are unavailable, or the person cannot access them
• People whose doctors estimate they have a life expectancy of at least 3 months and who are largely able to care for themselves and carry out light activities (confirm with trial site)
• People who have a suitable tumour tissue sample available (taken within the last 3 years) from an area that has not been previously treated with radiation, or who are able to provide a fresh tissue sample
• People whose blood test results within 7 days before starting the trial show that their bone marrow, kidneys, and liver are functioning at adequate levels (confirm with trial site for specific values)
• Women who could become pregnant must have a negative pregnancy blood test before starting, and must agree to use highly effective contraception from the screening visit until 90 days after the last dose
• Male participants with a partner who could become pregnant must agree to use highly effective contraception from the screening visit until 90 days after the last dose; those with a pregnant partner must agree to use a condom
• People who are willing and able to follow all requirements of the trial

Who may not be able to join:

• People who have received certain recent treatments too close to the trial start date, including chemotherapy within 3 weeks, biological or experimental therapies within 4 weeks (or based on how long the drug stays in the body, whichever is sooner), certain targeted therapies within 2 weeks, radiation therapy within 3 weeks (or 2 weeks for pain-relief radiation), or who had major surgery within 4 weeks
• People whose cancer got worse after previously being treated with immune checkpoint therapies, such as anti-PD-1 or anti-PD-L1 drugs
• People who still have significant ongoing side effects (grade 2 or higher) from a previous immunotherapy treatment
• People who are expected to need any other cancer treatment during the trial, including other medicines, radiation, or surgery
• People with a known allergy or sensitivity to any ingredient in the trial drug (balstilimab), a history of severe allergic reactions (anaphylaxis), or uncontrolled asthma
• People with an active autoimmune disease, or a history of autoimmune disease that required systemic treatment within the last 2 years (note: autoimmune conditions managed only with hormone replacement or topical treatments may still be eligible — confirm with trial site)
• People currently taking high-dose steroid tablets or other immune-suppressing medicines within specific timeframes before starting the trial (confirm with trial site for details; inhaled or topical steroids at low doses may be permitted)
• People who have previously received a transplant of donor tissue or a solid organ from another person
• People with significant active heart or cardiovascular problems, including a stroke or heart attack within the past 6 months, unstable chest pain, moderate-to-severe heart failure, serious uncontrolled heart rhythm problems, or a specific abnormal heart electrical reading (confirm with trial site)
• People with current or past lung inflammation conditions (interstitial lung disease or pneumonitis) that required steroid treatment
• People with untreated active hepatitis B or hepatitis C, or active tuberculosis
• People with uncontrolled HIV infection (note: people with well-controlled HIV on stable treatment with undetectable virus levels for at least 6 months may be eligible — confirm with trial site)
• People with other medical conditions or organ problems that the investigator believes could interfere with the trial
• People with known psychiatric conditions or substance use disorders that could affect their ability to participate safely
• People who do not have full legal capacity to consent
• People who are pregnant or breastfeeding
• People who have received a live or weakened vaccine within 14 days, or any other vaccine within 48 hours, before the first dose
• People with other health conditions that the treating doctor determines would change the balance of risks and benefits of the trial drug
• People taking other treatments that the treating doctor determines would change the balance of risks and benefits of the trial drug

Important: Always verify eligibility with the trial site directly before applying.