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, follow the study schedule, and agree to long-term follow-up for up to 15 years as required by health regulations
• People aged 18 to 75 years old
• People who have been diagnosed with a specific type of B-cell non-Hodgkin lymphoma (a cancer of the immune system) confirmed by tissue or cell testing, falling into one of these groups:
  • Group A1: Certain aggressive large B-cell lymphomas, including DLBCL, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, or transformed follicular lymphoma/Grade 3b follicular lymphoma
  • Group A2: Mantle cell lymphoma
  • Group B1: Follicular lymphoma, Grades 1 to 3a
  • Group B2: Chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL), not currently transformed into a more aggressive form
  • Group C: Primary central nervous system lymphoma (lymphoma affecting the brain or spinal cord)
• People who have received the required number of prior treatments for their specific lymphoma type (confirm with trial site for exact requirements per group), and whose disease has either not responded to or has worsened after their most recent treatment, or who could not tolerate it
• People whose scans show measurable disease activity meeting specific size or imaging criteria, or CLL patients who meet established criteria for needing treatment (confirm with trial site)
• People who are expected to survive for more than 12 weeks
• People whose general physical functioning is rated as largely normal to mildly limited (ECOG score 0–1 for most groups; up to score 3 is accepted for the brain lymphoma group)
• People whose blood test results meet the required levels for blood cell counts, kidney function, liver function, and blood clotting (confirm specific values with trial site)
• Women who could become pregnant must have a negative pregnancy test before starting and must agree to use highly effective contraception and avoid donating eggs for 1 year after receiving the study treatment
• Men must agree to use highly effective contraception and avoid donating sperm for 1 year after receiving the study treatment if sexually active with someone who could become pregnant

Who may not be able to join:

• Women who are pregnant or breastfeeding
• People with HIV, syphilis, active hepatitis B, or active hepatitis C infection
• People with any currently uncontrolled active infection, including active tuberculosis
• People who still have significant side effects from previous treatments that have not sufficiently resolved (with some exceptions at the investigator's discretion, such as hair loss)
• People who had an autologous stem cell transplant (using their own stem cells) within the 12 weeks before signing the consent form
• People who have previously received treatment that targeted a protein called CD19, unless tests show that CD19 or CD20 is still present on their cancer cells
• People who have received certain cancer treatments within approximately 14 days or 5 half-lives (whichever is shorter) before starting the conditioning phase of the study, unless a very small area of bone marrow was involved in radiotherapy
• People who have been taking high-dose steroid tablets (equivalent to more than 15 mg of prednisone per day) within the 7 days before signing the consent form (topical steroids applied to the skin are excepted)
• People who have received any vaccine — including live, inactivated, or RNA vaccines — within 4 weeks before signing the consent form
• People with known allergies or intolerances to the study's preparatory drugs, a drug called tocilizumab, or to components of the cell treatment (including a substance called DMSO), or those with a history of severe allergic reactions such as anaphylactic shock
• People who have had certain serious heart conditions within the 6 months before screening, including severe heart failure, heart attack, coronary bypass surgery, unstable chest pain, serious uncontrolled heart rhythm problems, severe non-ischaemic heart muscle disease, low heart pumping function (below 45%), or other heart conditions the investigator considers a risk
• People with blood oxygen levels below 92%, or other serious lung conditions that the investigator considers life-threatening
• People who have or have had a second, separate cancer requiring treatment or not fully resolved within the past 2 years (certain low-risk, successfully treated skin, prostate, breast, cervical, bladder, or thyroid cancers may be excepted — confirm with trial site)
• People who have had major surgery within 2 weeks before signing the consent form, or who have planned major surgery during the study or within 4 weeks of receiving the study treatment (minor procedures under local anaesthetic, such as cataract surgery, are generally excepted)
• People who are unable or unwilling to follow the study requirements, or who the investigator considers otherwise unsuitable for the trial

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