Phase 1 Lymphoma Trial, Recruiting

Written by an AI model from 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 aged 18 to 75 years old (inclusive).
• People with a reasonable level of physical functioning and a life expectancy of more than 3 months.
• People with locally advanced or metastatic solid tumours, or relapsed/returned or treatment-resistant lymphomas, confirmed by laboratory testing, where the tumour has tested positive for a specific protein called EphA2 (in at least 20% of cells) and carries one of four specific TP53 gene mutations (R273H, R175H, R248Q, or R249S) — confirmed within the 6 months before screening. People with a second, separate cancer may also be considered.
• People with solid tumours who have not responded to standard first-line treatment, or for whom no standard treatment exists. For lymphomas, people whose disease has come back after at least 2 rounds of treatment, or whose disease has not responded to treatment. People for whom standard treatment is not available or who have chosen not to pursue it may also be considered, provided the reasons are recorded.
• People who have at least one tumour that can be measured at the start of the trial, according to standard measurement guidelines.
• People whose blood counts and organ function (including liver and kidneys) meet specific minimum levels set by the trial (confirm with trial site for exact values).
• People who are willing to have a tumour tissue sample taken (either a biopsy or previously preserved tissue sample).
• People who are willing and able to attend all required visits and assessments at the treating institution.
• People who are able to read, understand, and sign a written consent form.

Who may not be able to join:

• People who carry one of the four specific TP53 mutations (R273H, R175H, R248Q, or R249S) as an inherited (germline) mutation, rather than in the tumour itself.
• People with currently active cancer involvement in the brain or central nervous system, or who have previously experienced a severe drug-related central nervous system reaction. People with previously treated and now stable brain metastases — treated at least 4 weeks before enrolment — may still be considered.
• People who have previously received an organ transplant from a donor or an allogeneic stem cell transplant (where stem cells came from another person).
• People with an active, uncontrolled viral, bacterial, or fungal infection.
• People who have tested positive for HIV or have been diagnosed with AIDS.
• People with an active hepatitis B or hepatitis C infection.
• People with a history of autoimmune disease (within the last 5 years) or those at risk of it, who have been taking immune-suppressing medications or higher-dose corticosteroids (more than 10 mg/day of prednisone or equivalent) within 28 days before enrolment. People who received a short course of corticosteroids (for example, before receiving another medication) may still be considered.
• People who have had major surgery or a serious physical injury within the 4 weeks before enrolment.
• People who have previously received treatment specifically targeting the same TP53 mutations and EphA2 protein that this trial targets.
• People who have received systemic chemotherapy or other relevant treatments within 2 weeks before the trial vaccination.
• People who are currently participating in, or who withdrew from, another clinical trial within the past 4 weeks.
• People with serious ongoing medical conditions (such as lung, kidney, liver, digestive, or neurological conditions) or psychiatric conditions that could affect safe participation or the ability to follow the trial requirements.
• People who have received any vaccine within 30 days before enrolment.
• People who are pregnant, breastfeeding, or currently lactating.
• People whom the researchers determine are not suitable for the trial for other reasons (confirm with trial site).

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