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:

• Children and young adults aged 24 or younger who have a type of blood cancer called acute lymphoblastic leukaemia (ALL) that has specific markers on the cancer cells (called CD19+ and CD22+), AND meet at least one of the following high-risk conditions:
• The cancer did not respond well to the first round of treatment (more than 5% cancer cells remaining after initial chemotherapy)
• High levels of remaining cancer cells were still detected at a second check during standard front-line treatment
• Very young babies (under 6 months old at diagnosis) with a specific gene change (MLL rearrangement) and either a very high white blood cell count or a poor early response to steroid treatment
• Patients whose cancer has a specific genetic change called t(17;19) TCF3-HLF
• Patients whose cancer came back early (within 18 months of diagnosis, while still on treatment, or within 6 months of finishing treatment), or came back with certain high-risk genetic features
• Young people aged 16–24 whose cancer came back at any point while still on treatment
• Any baby whose ALL has come back after treatment
• Patients whose ALL has come back two or more times
• Patients whose ALL came back but did not respond to at least one round of standard chemotherapy
• Patients with high levels of remaining cancer cells detected before a planned stem cell transplant
• Patients whose ALL came back and who would benefit from a stem cell transplant but have no suitable donor or cannot have a transplant for another reason
• Patients whose ALL came back after a stem cell transplant, as long as the CAR T-cell treatment would be given at least 4 months after the transplant
• Patients who previously received a specific CAR T-cell therapy (Tisagenlecleucel) and either lost its effect within 6 months or whose cancer came back with the CD19 and CD22 markers still present
• Patients whose cancer has only returned in the fluid around the brain or spinal cord (isolated CNS relapse) and who meet one of the above conditions are also eligible
• Patients (or their guardians) who agree to pregnancy testing and to use adequate contraception if applicable
• Patients (or their guardians) who are able to give written informed consent

Who may not be able to join:

• People with an active Hepatitis B, Hepatitis C, or HIV infection
• People whose blood oxygen level is too low (90% or below while breathing normal air)
• People with significantly raised bilirubin levels in their blood (a marker of liver function) — more than 3 times the normal upper limit
• People with significantly raised creatinine levels in their blood (a marker of kidney function) — more than 3 times the normal upper limit
• Women who are pregnant or breastfeeding
• Patients who have had a stem cell transplant and are currently experiencing significant transplant-related immune reactions (called GVHD) that require steroid treatment
• People who are unable to tolerate the process of collecting immune cells from the blood (called leukapheresis)
• People whose general health and ability to function is assessed as too poor based on standard scoring scales used for their age group
• People with a serious pre-existing neurological (brain or nerve) condition, not caused by the cancer itself
• People whose cancer cells do not have the CD19 or CD22 markers
• People who have a severe active infection at the time the CAR T-cell treatment is due to be given
• People who need extra oxygen or have active lung problems at the time the CAR T-cell treatment is due to be given
• Stem cell transplant recipients who are experiencing significant GVHD requiring steroids at the time the CAR T-cell treatment is due to be given (they may become eligible once the GVHD has resolved and steroids have been stopped)

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