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 who have been diagnosed (confirmed by laboratory tissue testing) with a type of blood cancer called large B-cell lymphoma that has come back or stopped responding to treatment. This includes several specific subtypes such as diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, grade 3B follicular lymphoma, and primary mediastinal large B-cell lymphoma.
• People whose lymphoma can be detected and measured on a specific type of scan called an FDG-PET/CT scan, which shows active tumour sites in the body.
• People whose cancer would make them eligible for a standard, FDA-approved CAR T-cell therapy (either axi-cel/Yescarta® or liso-cel/Breyanzi®) based on the current approved guidelines for those treatments.
• People who have previously had an autologous stem cell transplant (using their own stem cells), as long as it was at least 3 months ago.
• People who are 18 years of age or older.
• People who are reasonably active and able to care for themselves, as measured by a standard medical scoring tool called ECOG performance status (score of 2 or below, meaning able to carry out basic self-care).
• People whose blood counts and organ function (bone marrow, liver, and kidneys) meet specific minimum levels at the start of the pre-treatment chemotherapy phase (confirm specific values with the trial site).
• People whose heart electrical activity, measured by an ECG, shows a specific reading called QTcF below 500 ms — those with a higher reading may still be considered if a heart specialist gives clearance.
• People who are willing and able to use effective contraception before, during, and for 90 days after the study treatment, and who agree to notify their treating doctor immediately if pregnancy occurs or is suspected during that period.
• People who are able to understand the study and are willing to sign a formal consent form (a legal representative may do this on their behalf if needed).

Who may not be able to join:

• People who have previously received a transplant of an organ or bone marrow from another person (allogeneic transplant).
• People who have or have had another type of cancer that could interfere with assessing the safety or effectiveness of the trial treatment.
• People who have received chemotherapy, biological therapy, or hormonal cancer treatment within 14 days before the first injection of the trial drug (NT-I7). Note: hormonal treatments for non-cancer conditions such as diabetes or menopause are acceptable.
• People who are currently taking part in another clinical trial, or have done so within 14 days before the first NT-I7 injection.
• People whose lymphoma has spread to the brain or spinal cord (central nervous system involvement).
• People who have had a significant allergic reaction to substances chemically or biologically similar to the trial drug or other agents used in the study.
• People who still have significant side effects from previous cancer treatment that have not resolved to a mild level (with some exceptions such as hair loss, or certain long-term effects such as hearing loss or nerve damage that are not expected to worsen with this treatment — confirm with trial site).
• People with serious uncontrolled illnesses, including active infections (such as active hepatitis A or tuberculosis), moderate-to-severe heart failure, uncontrolled irregular heart rhythm (atrial fibrillation), or serious heart events such as a heart attack, chest pain requiring treatment, or heart surgery within the past 6 months.
• People who have had an active autoimmune disease in the past 2 years (such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease). Some milder conditions such as vitiligo, controlled thyroid disease, or mild psoriasis are exceptions to this — confirm with the trial site.
• People for whom receiving an injection into a muscle (intramuscular injection) is not medically suitable.
• People who have received a live vaccine (such as certain flu, measles, or other live vaccines) within 30 days before the NT-I7 injection.
• People who are pregnant, breastfeeding, or planning to conceive a child during the study period or within 90 days after the last dose of NT-I7. A negative pregnancy test is required within 72 hours before receiving CAR T-cell treatment for women who could potentially be pregnant.
• People living with HIV who are not on effective antiviral medication, or whose virus levels have not been undetectable for at least 6 months.
• People with chronic hepatitis B virus (HBV) infection where the virus is still detectable, even if on treatment. Those with undetectable HBV levels while on suppressive therapy may still be considered.
• People with a history of hepatitis C virus (HCV) infection that has not been cured, or where the virus is still detectable. Those who have been successfully treated and cured, or who are on treatment with undetectable virus levels, may still be considered.

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