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:

• Adults aged 18 or older who are able to give written consent to take part.
• People who are willing and able to follow the trial's procedures and schedule.
• People with a reasonable level of physical fitness and ability to carry out daily activities (assessed using a standard scale called ECOG, with a score of 0, 1, or 2).
• People with Multiple Myeloma (a blood cancer) whose disease has come back or stopped responding to treatment, and who have already received at least two rounds of treatment including specific types of drugs (an immunomodulatory drug, a proteasome inhibitor, and a certain type of antibody therapy).
• People with Multiple Myeloma for whom the treating doctor has determined that no other suitable standard treatments remain available.
• People with Multiple Myeloma who still have a measurable amount of disease detectable through specific blood or urine tests (confirm with trial site).
• People with Diffuse Large B-Cell Lymphoma (DLBCL, an aggressive blood cancer) whose disease has come back or stopped responding to standard initial treatment and at least one standard rescue treatment, OR who relapsed within one year after high-dose chemotherapy with a stem cell transplant using their own cells, OR who relapsed after a donor stem cell transplant or an approved CAR T-cell therapy.
• People with DLBCL for whom the treating doctor has determined that no other suitable standard treatments remain available, and whose disease is still measurable.
• People whose blood counts, liver, kidneys, and heart are functioning at an adequate level as defined by specific test results (confirm with trial site for exact thresholds).
• Women of childbearing potential who have a negative pregnancy test at the screening stage and who are using a highly effective form of contraception.
• Male participants who are willing to use a highly effective form of contraception and to avoid fathering a child for at least 12 months after receiving the CAR T-cell treatment.

Who may not be able to join:

• People whose cancer has spread to the brain or central nervous system.
• People who have had a seizure, stroke, or bleeding in the brain within the past 12 months.
• People with a history of an autoimmune disease affecting the brain or nervous system (such as multiple sclerosis or optic neuritis).
• People with existing neurological conditions that the treating doctor believes could increase safety risks or make it harder to monitor for side effects during the trial.
• People who need continuous oxygen support due to poor lung function.
• People currently receiving dialysis for kidney failure.
• People for whom the chemotherapy drugs used to prepare the body for treatment (Fludarabine and/or Cyclophosphamide) are medically unsuitable.
• People with another active cancer that requires ongoing treatment or that could interfere with measuring trial results (hormonal maintenance therapy for cancer is allowed).
• People who test positive for HIV antibodies.
• People with active or long-term hepatitis B or C infection, unless test results show the virus is no longer detectable.
• People with a current COVID-19 infection, a COVID-19 infection within the past 3 months, or ongoing long COVID symptoms.
• People with an uncontrolled bacterial, viral, or fungal infection currently requiring hospital-based or intravenous antibiotic or antiviral treatment.
• People with active Graft versus Host Disease (a complication after donor stem cell transplant), or who have been on treatment or prevention for this condition within the 30 days before receiving the trial treatment.
• People with psychological disorders, substance misuse issues, or any other condition that could significantly affect their ability to follow the trial protocol.
• People who the treating doctor believes are likely to deteriorate significantly during the time needed to manufacture the trial treatment, even with supportive therapy.
• People currently taking immune-suppressing medications, including steroids at doses above a certain level (equivalent to more than 20 mg of Prednisolone per day).
• People who have received any cancer treatment within 7 days before the cell collection procedure, or within 2 weeks (or 5 half-lives, whichever is shorter) before the preparatory chemotherapy begins.
• People who have received any other experimental treatment within 4 weeks (or 5 half-lives, whichever is shorter) before the cell collection procedure or preparatory chemotherapy.
• People with a known history of allergic reactions to any of the drugs or substances used as part of this trial.
• People who have received a live vaccine within 2 weeks before the cell collection procedure or the start of preparatory chemotherapy.
• Women who are pregnant or breastfeeding (breastfeeding must be stopped before and during treatment, and for at least 3 months after treatment ends).
• Women of childbearing potential who do not meet specific criteria around menopause, surgical sterilisation, use of highly effective contraception, abstinence, or a vasectomised partner (confirm specific criteria with trial site).
• People with a known allergy or sensitivity to any of the drugs used in this trial or to chemically similar drugs.
• People currently participating in another interventional clinical trial, or who have done so within the 4 weeks before joining this trial.
• People whose health or personal circumstances mean they are unlikely to be able to follow the trial protocol.

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