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 between 18 and 75 years old
• People who have signed a consent form agreeing to take part in the study
• People who are able to follow the study schedule and requirements
• People diagnosed with B-cell acute lymphoblastic leukemia (a type of blood cancer affecting B-cells) that has come back or has not responded to treatment, meeting at least one of the following situations:
  • The cancer has come back in the bone marrow two or more times
  • The cancer never went away after two rounds of standard chemotherapy, or did not go away after one round of chemotherapy given for a relapse
  • People with a specific type of leukemia linked to the Philadelphia chromosome who could not tolerate, or did not respond to, two different targeted therapies (called tyrosine kinase inhibitors)
  • People whose cancer has come back but who are not able to have a donor stem cell transplant because no suitable donor is available
  • People whose cancer came back after a donor stem cell transplant, at least 12 weeks after the transplant or after stopping anti-rejection medications
  • People whose cancer came back after a previous CAR T-cell therapy, where the cancer cells still carry the CD19 marker (confirm with trial site)
• People whose bone marrow testing shows at least 5% cancer cells at the time of screening
• People with confirmed CD19 markers on their cancer cells in bone marrow or blood testing within one month before joining (for those whose cancer has relapsed)
• People who previously had cancer involvement in the brain or spinal fluid, but who are confirmed to be in remission in that area before registering
• People whose liver enzyme levels (ALT) are no more than five times the normal upper limit
• People whose bilirubin (a liver marker) is no more than twice the normal upper limit
• People whose kidneys are working well enough, with a clearance rate of at least 60 cc/min as measured by a standard formula
• People with a sufficient level of infection-fighting white blood cells (neutrophils of at least 1.0 x 10⁹/L) without needing growth factor support
• People with a platelet count of at least 50 x 10⁹/L without having needed a transfusion in the 7 days before screening
• People with a lymphocyte count of at least 0.5 x 10⁹/L
• People whose kidneys, liver, lungs, and heart are functioning adequately, including:
  • Kidney filtration rate above 60 mL/min
  • Liver enzyme and bilirubin levels within acceptable ranges (confirm with trial site regarding Gilbert's syndrome exception)
  • Blood oxygen level of 93% or above while breathing normal room air
  • Heart pumping function (ejection fraction) of at least 45%, and a normal heart rhythm reading (QTcF no more than 480 ms)
• People with no more than mild breathlessness and blood oxygen levels above 93% on room air
• People with confirmed heart pumping function of at least 45% on a heart scan done within 30 days of screening
• People with a general health and activity level score meeting the required threshold (Karnofsky score of 70% or above, and/or an ECOG score of 0–2) at screening
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before enrolling
• People who are sexually active and meet the contraception requirements:
  • Women who could become pregnant must use effective birth control starting one month before screening and continuing for 12 months after the CAR T-cell infusion
  • Men must use a condom for six months after the infusion
• People who are eligible to have a leukapheresis procedure (a process to collect immune cells), or who already have a suitable stored cell collection available

Who may not be able to join:

• People with active cancer involvement in the brain or spinal fluid at the time of joining
• People with a history of, or currently uncontrolled, seizure disorder not caused by their leukemia
• People with significant heart or blood vessel problems, including any of the following:
  • A stroke within the past 24 months, or ongoing effects from a previous stroke
  • A mini-stroke (transient ischemic attack) within the past 12 months
  • A heart attack within the past 36 months
  • Severe or unstable heart failure, unstable chest pain, or a heart rhythm problem requiring treatment
  • Uncontrolled irregular heartbeat, or a history of serious heart rhythm problems requiring medication
  • Active or ongoing symptoms from coronary heart disease or angina
  • Heart pumping function below 45% on a heart scan
• People whose kidney clearance rate is below 60 (confirm units and formula with trial site)
• People with inherited conditions that affect bone marrow function, such as Fanconi anemia, Kostmann syndrome, or Shwachman syndrome (people with Down syndrome are not excluded)
• People diagnosed with Burkitt lymphoma or Burkitt leukemia (a specific subtype)
• People with a history of another cancer, unless it was a skin or cervical pre-cancer that was fully treated with no signs of active disease
• People who have previously received any gene therapy other than CAR T-cell therapy
• People who tested positive for HIV within 8 weeks before screening
• People with active hepatitis B or C infection — those with certain hepatitis markers must have a negative PCR test before enrolling; a positive PCR result means they cannot join
• People who have taken part in another clinical trial and received an experimental treatment within 30 days before screening
• People who are currently pregnant
• People who are currently breastfeeding
• Women who could become pregnant, and all male participants, who are not using highly effective contraception for at least one year after the CAR T-cell infusion
• People currently taking high-dose steroid medications (equivalent to 0.5 mg/kg or more of prednisone per day) — these must be stopped more than 72 hours before the preparatory chemotherapy begins
• People still taking certain targeted therapies (TKIs) or hydroxyurea — these must be stopped more than 72 hours before the preparatory chemotherapy
• People still taking certain chemotherapy drugs — various stopping timeframes apply depending on the specific drug (confirm details with trial site)
• People who have received pegylated asparaginase within 4 weeks before the CAR T-cell infusion
• People who have received brain/spinal fluid chemotherapy within one week before the CAR T-cell infusion
• People who have had radiation therapy to areas other than the brain or spine within 2 weeks before the CAR T-cell infusion
• People who have had radiation therapy directed at the brain or spine within 8 weeks before the CAR T-cell infusion
• People with a known history of severe allergic reactions to any of the drugs used in the study, including the preparatory chemotherapy drugs or substances used in storing the CAR T-cells (confirm with trial site)
• People who have had an autologous (own cells) stem cell transplant within 6 weeks of the planned CAR T-cell infusion
• People with evidence of a bone marrow condition called myelodysplasia, or related chromosomal changes, found on any bone marrow biopsy before starting treatment
• People with a known primary immune deficiency disorder
• People who have received a live vaccine within 4 weeks before enrolling, or within 6 weeks before the preparatory chemotherapy begins

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