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 are willing to sign a consent form agreeing to follow all study procedures for the full length of the study.
• People aged 12 years or older.
• People who have been diagnosed with a type of blood cancer involving CD4+ T cells, where the cancer has come back after treatment, has not responded to treatment, or has not responded well enough after 4–6 rounds of standard chemotherapy. People who have previously had a bone marrow or stem cell transplant may also be eligible, provided no donor cells remain in their body.
• People whose kidneys are functioning well enough, based on a specific blood test result (confirm with trial site).
• People whose liver enzyme levels (ALT and AST) are below three times the upper limit of the normal range.
• People whose bilirubin level (a liver-related measure) is below twice the upper limit of the normal range.
• People who do not need extra oxygen while at rest.
• People whose heart is pumping with at least 50% efficiency, as measured by a cardiac test.
• People who have suitable veins for the blood-collection process (called apheresis) and no medical reasons preventing this procedure.

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People who have an active, uncontrolled infection currently requiring treatment with systemic (whole-body) medications.
• People with an active hepatitis B or hepatitis C infection. However, people who previously had hepatitis B or C and completed antiviral treatment with no detectable virus for at least 6 months before joining may still be considered eligible (confirm with trial site).
• People who are currently taking high-dose steroid medications (such as prednisone) on an ongoing basis, or who are heavily dependent on steroids for an underlying condition. People taking low replacement doses of steroids for certain conditions may still be considered (confirm with trial site). Inhaled steroids are not a reason for exclusion.
• People with any other serious, uncontrolled health condition that the treating doctor believes would make participation unsafe.
• People who are living with HIV.
• People who do not consent to the treatment.
• People who have received or are expected to receive a live vaccine within 30 days before the first experimental treatment. Standard inactivated flu vaccines are allowed.
• People who have an active autoimmune disease that has required systemic treatment (such as disease-modifying drugs, steroids, or immune-suppressing medications) within the past 2 years. Some exceptions apply, including people with vitiligo or long-term remission of childhood asthma (confirm with trial site).
• People with a history of serious mental health conditions or substance misuse that may affect their ability to follow the study requirements.
• People who have had a different, unrelated active cancer that has required treatment within the last 3 years, or that has not fully gone away. Some exceptions may apply, such as successfully treated non-spreading skin cancers or certain prostate cancers not requiring treatment (confirm with trial site).
• People who have received an experimental cell or gene therapy within the past 6 months.
• People who have received any other experimental anti-cancer treatment within 14 days of starting the study, or within 5 half-lives of that treatment — whichever is the shorter time period.

Additional checks before receiving the conditioning chemotherapy and the cell treatment:

• Heart, kidney, and liver function must remain at acceptable levels, similar to when the person first joined.
• There must be no major new health changes (such as a heart attack or stroke).
• The experimental cell product must have been successfully made and passed quality checks.
• A pregnancy test must be negative (where applicable).
• At the time of the cell infusion, the person must not have a fever, must not be needing extra oxygen, must not have a new uncontrolled heart rhythm problem, must not have dangerously low blood pressure, and must have had no positive blood infection results within 48 hours of the planned infusion.

Contraception requirements:

• People who could become pregnant must have a negative pregnancy test before the conditioning chemotherapy begins.
• All participants must agree not to try to conceive a child while enrolled in the trial, and must use two reliable forms of contraception from the time of consent until at least 90 days after the cell infusion (confirm acceptable methods with trial site).
• People who are not able to conceive — such as those who have been through menopause for at least 24 consecutive months or who have had a sterilisation procedure — may be exempt from contraception requirements, with appropriate documentation provided to the trial site.

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