Early Phase 1 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 have agreed to take part willingly and have signed a consent form, and who are able to follow the study plan.
• People aged 18 to 75 years (inclusive), of any gender.
• People who have been diagnosed with acute B-cell lymphoblastic leukemia or B-cell lymphoma that has come back or has not responded to previous treatment, diagnosed using the WHO 2016 classification.
• People whose cancer cells have tested positive for a protein called CD19, confirmed by laboratory testing.
• People who are fully active or have only minor restrictions in physical activity, as measured by a standard doctor's scoring tool called the ECOG scale (score of 0 or 1).
• People whose doctors expect them to survive for more than 12 weeks.
• People who have waited long enough after their last cancer treatment before starting this study — at least 2 weeks or 5 half-lives (whichever is shorter) for most treatments, or at least 3 half-lives or 28 days (whichever is shorter) for certain immune-based therapies such as anti-PD-1 or anti-PD-L1 drugs.
• People whose side effects from previous treatments have mostly cleared up and are rated at a mild level (grade 1 or lower), apart from minor things like hair loss.
• People whose kidneys, liver, lungs, and heart are working well enough, based on blood tests and heart scans showing results within required ranges (confirm with trial site for specific values).
• Women who could become pregnant must have a negative pregnancy test before joining, agree to use reliable contraception for 1 year after receiving the study treatment, and must not donate eggs within 1 year after receiving the treatment.
• Men who are sexually active with women who could become pregnant must agree to use reliable contraception for 1 year after receiving the study treatment, and must not donate sperm within 1 year after receiving the treatment.

Who may not be able to join:

• People who have had leukemia or lymphoma that has spread to the brain or spinal fluid, or where brain imaging during screening shows signs of this.
• People who have had leukemia or lymphoma in the testicles, where scans during screening suggest it is still active.
• People who have had another untreated cancer in the past 5 years or at the same time as their current cancer — though certain early-stage or well-treated cancers (such as some skin cancers, early cervical cancer, or localised prostate cancer under active surveillance) may still be considered (confirm with trial site).
• People who had a stem cell transplant intended to cure their cancer within the 6 weeks before the planned treatment date.
• People who received an allogeneic (donor) stem cell transplant less than 6 months before joining the trial.
• People who have previously received a type of immune cell therapy called CD19 CAR-T or CAR-NK therapy — unless they previously received the specific study treatment (GT719) and meet criteria for re-treatment.
• People who have taken steroid medications (taken by mouth or injection) within 7 days before the cell infusion (inhaled steroids are allowed).
• People who have had allergic reactions to any of the drugs used in this study, including the study treatment GT719, cyclophosphamide, or fludarabine.
• People who have an active or suspected infection that is not under control, or that requires antibiotic, antifungal, or antiviral treatment given through a drip (intravenously).
• People who test positive for HIV, syphilis, or active CMV or EBV infection (specific antibody tests).
• People with active hepatitis B or active hepatitis C — though people with certain inactive hepatitis B markers and normal virus levels in the blood may still be considered (confirm with trial site).
• People who have drainage tubes or catheters in place (such as kidney, bladder, or chest drain tubes) — though standard central venous lines like Port-a-Cath or Hickman catheters are allowed.
• People with a history of or current nervous system conditions such as seizures, stroke, dementia, or autoimmune diseases affecting the brain or nervous system.
• People whose lymphoma has spread into the chambers of the heart.
• People who have had serious heart or blood vessel problems in the past 6 months, including heart failure, heart attack, stroke, dangerous heart rhythm problems, very high blood pressure that is not well controlled, poorly controlled diabetes, blood clots in the lungs, or serious lung problems.
• People whose cancer is causing or is likely to cause a medical emergency within 6 weeks that would require urgent treatment.
• People who have a condition where the immune system does not work properly from birth (primary immunodeficiency).
• People who have had a blood clot in a deep vein or the lungs within the past 6 months and needed blood-thinning medication.
• People with any other medical condition that could affect how safely or accurately the study treatment can be assessed.
• People who received certain vaccines — live, weakened, or mRNA vaccines within 8 weeks before the pre-treatment conditioning phase, or inactivated vaccines within 4 weeks before.
• Women who are pregnant or breastfeeding.
• People who are not willing to use contraception from the time of signing consent until at least 6 months after finishing treatment.
• People who, in the opinion of the study doctor, are unlikely to complete all required visits and follow-up appointments.
• People who have had an autoimmune disease in the past 2 years that caused organ damage or required ongoing immune-suppressing medication — such as Crohn's disease, rheumatoid arthritis, or lupus.

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