Phase 2 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 at the time of signing consent forms.
• People who have signed a consent form agreeing to take part and allowing their personal health information to be used.
• People with a type of lymphoma called CD30-positive peripheral T-cell lymphoma, confirmed by a tissue or cell sample, classified according to the 2017 World Health Organization system.
• People whose lymphoma tissue still shows CD30 positivity (a specific marker on cancer cells) based on testing of a stored tissue sample taken after their most recent CD30-targeted treatment.
• People who have a reasonably good level of physical functioning, as measured by a standard scale used by doctors (Karnofsky score above 60%) (confirm with trial site).
• People who have already received at least two previous rounds of treatment for their lymphoma.
• People who have received only one previous round of treatment, if their lymphoma did not respond to that treatment or came back within 12 months of finishing chemotherapy or a stem cell transplant, and if that treatment included a drug called brentuximab vedotin — or if brentuximab vedotin was not a suitable option for them.
• People whose lymphoma came back after an autologous stem cell transplant (a transplant using their own stem cells).
• People whose lymphoma came back after an allogeneic stem cell transplant (a transplant using someone else's stem cells), provided it has been at least 180 days since the transplant, they are no longer on medicines to prevent or treat graft-versus-host disease, and they have no signs of active graft-versus-host disease.
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is unlikely to interfere with how this trial measures safety or effectiveness (confirm with trial site).
• Women of childbearing potential who have a negative pregnancy blood test within 72 hours before the cell collection procedure.
• Women of childbearing potential who are willing to either avoid heterosexual activity or use two reliable forms of contraception from the time of consent until 6 months after stopping the study treatment, and who will inform male partners to use a condom.
• People who the trial investigator believes are able and willing to follow all study procedures.
• People with a life expectancy of at least 6 weeks at the time of cell collection.
• People whose organ function meets required levels at the time of cell collection, including adequate blood counts, liver function, kidney function, and oxygen levels (confirm with trial site for specific values).
• People who have had recent imaging (within 90 days before cell collection) showing active disease.
• People whose organ function meets required levels before the preparatory treatment (called lymphodepletion) that comes before the cell infusion, including adequate blood counts, liver function, kidney function, and oxygen levels (confirm with trial site for specific values).
• People for whom a sufficient supply of their prepared personalised T-cell treatment has been successfully manufactured and meets quality standards.
• People who show signs of benefit from the first cell infusion — such as stable or improved disease — before a possible second round of treatment.

Who may not be able to join:

• People who are pregnant or breastfeeding (breast milk cannot be stored for later use during the study).
• People currently taking systemic steroid medicines (such as prednisone) at a dose of 10 mg or more per day, though lower doses may be considered at the investigator's discretion; inhaled steroids are permitted.
• People with an active HIV, HTLV, or hepatitis C (HCV) infection.
• People who test positive for the hepatitis B surface antigen, or who test negative for it but positive for a related hepatitis B marker and also have detectable hepatitis B virus in their blood.
• People who have had major surgery within 28 days before the preparatory treatment phase.
• People who have received any experimental treatments or cancer vaccines within the 6 weeks before the preparatory treatment phase.
• People who have received anti-CD30 antibody-based therapy within 4 weeks before the preparatory treatment phase.
• People who have received chemotherapy within 3 weeks before the preparatory treatment phase.
• People whose disease is considered to be rapidly worsening, as judged by their treating cancer doctor.
• People who their treating cancer doctor does not consider to be good candidates for this type of CAR T-cell therapy.
• People taking certain strong medications that affect how the preparatory chemotherapy drug (bendamustine) is processed by the body, in the period around that treatment (confirm with trial site for the specific medicines involved).
• People taking any other prohibited or incompatible medications before the preparatory treatment phase.
• People with signs of an uncontrolled infection or sepsis at the time of cell infusion.
• People who experienced severe side effects (grade 4) involving the immune system or the brain and nervous system during the first cell infusion, unless their lymphoma showed at least a partial response to that first infusion, before a second round of treatment is considered.

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