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 or older
• People with a confirmed diagnosis of a CD19-positive B-cell blood cancer (a specific type of cancer affecting immune cells) that has come back or stopped responding to treatment, including certain types of non-Hodgkin lymphoma or chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL)
• People with non-Hodgkin lymphoma who have been through at least two previous treatments (including at least one specific type of chemotherapy called an anthracycline, unless it was not tolerated), and whose cancer did not respond well to the most recent treatment
• People with a specific type of lymphoma called Richter Transformation who have had at least one prior treatment, including a type of drug called a BTK inhibitor
• People with CLL or SLL who have had at least two prior treatments, or at least six months of a second-line treatment with a BTK inhibitor (such as venetoclax or ibrutinib) — with some exceptions that the trial site can confirm
• People whose cancer can be detected and measured on a scan, with at least one tumour area larger than 1.5 cm, or a high enough level of cancer cells in the blood (for CLL/SLL)
• People who are well enough to carry out daily activities with little or no limitation (as assessed using a standard medical scale)
• People with blood test results showing adequate levels of red blood cells, white blood cells, and platelets, taken within 14 days before joining
• People with liver function test results within acceptable ranges, taken within 14 days before joining
• People with blood clotting test results within acceptable ranges, taken within 14 days before joining
• People with adequate kidney function, tested within 14 days before joining
• People whose heart is pumping at least 50% effectively, with no significant fluid around the heart, confirmed by a heart scan
• People with a blood oxygen level of at least 92% while breathing normal room air
• People of childbearing potential who have a negative pregnancy test within 7 days before joining
• People of childbearing potential (including those who have had a tubal ligation) who are willing to use two highly effective forms of contraception for the full duration of the study and for 12 months after receiving the trial treatment
• People who are willing to provide written consent to participate
• People willing to provide blood samples for research purposes
• People willing to return to the trial site for follow-up visits during the monitoring phase of the study

Who may not be able to join:

• People who are pregnant or breastfeeding
• People of childbearing potential who are not willing to use highly effective contraception
• Sexually active males who are not willing to use contraception during the study and for at least 12 months after receiving the trial treatment
• People for whom a commercially approved CD19 CAR T-cell therapy (a type of cancer treatment already on the market) is available and obtainable (confirm with trial site)
• People who have received a live vaccine within 6 weeks before joining
• People who have had their own stem cells transplanted (autologous transplant) within 6 weeks before joining
• People who had a donor stem cell transplant (allogeneic transplant) fewer than 100 days before joining, or who still have active graft-versus-host disease, or who are still taking medication to suppress their immune system after a transplant
• People with a history of seizures, stroke, bleeding in the brain, dementia, or certain diseases affecting the brain or nervous system
• People with a primary immune deficiency condition (a condition where the immune system does not work properly from birth)
• People currently needing high-dose steroid treatment (more than 20 mg per day of prednisone or an equivalent)
• People with a history of a severe allergic reaction to CAR T-cell therapy, stem cell infusion, or related preservation ingredients
• People with a history of another cancer, unless it was a very early-stage cancer or a non-serious skin cancer, or the person has been cancer-free for at least 2 years
• People with a significant active infection (minor infections such as a urinary tract infection or throat infection may be acceptable — confirm with trial site), or people who are currently on or recently received antibiotics given through a drip within the past 7 days
• People with a known history of HIV, or active or chronic hepatitis B or hepatitis C (people who have fully cleared a past hepatitis infection, confirmed by appropriate testing, may be eligible — confirm with trial site)
• People who have had certain serious heart conditions within the past 6 months, including severe heart failure, a heart attack, unstable chest pain, a heart procedure such as angioplasty or stenting, or other significant heart disease
• People with any other serious medical or mental health condition that, in the treating doctor's judgement, would make participation unsafe or unsuitable
• People currently receiving other cancer treatments may not be immediately eligible, though some exceptions apply depending on timing before a specific procedure called leukapheresis (confirm with trial site)

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