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:

• The participant (or their legal representative) must be willing to sign a consent form showing they understand the study and agree to take part.
• People who are reasonably physically functional — rated 0, 1, or 2 on a standard cancer performance scale (confirm with trial site).
• People whose doctors estimate they are likely to live for more than 12 weeks.
• People who have been definitively diagnosed with a type of blood cancer called CD19-positive B-cell acute lymphoblastic leukemia (B-ALL), and whose disease fits one of these situations:
  • For a type without the Philadelphia chromosome (Ph-negative): the cancer did not go into remission after the first round of treatment; or it did not respond to further treatment attempts; or it came back within 12 months of first remission; or it has relapsed a second time or more; or it came back after a stem cell transplant.
  • For a type with the Philadelphia chromosome (Ph-positive): the cancer stopped responding to one or more targeted drugs called TKIs, or the person could not tolerate those drugs, or a specific gene mutation (T315I) is present.
• People who have at least 5% abnormal cancer cells (blasts) in a bone marrow sample.
• People who have largely recovered from side effects of previous cancer treatments (most side effects must be at a mild or resolved level, except for hair loss).
• People with adequate blood counts and organ function as assessed by the trial site.
• Women who could become pregnant must have a negative pregnancy blood test before starting, and must use highly effective contraception throughout the study and for 3 months after the last dose.
• Male participants must agree to use reliable contraception (such as barrier methods or abstinence) and must not donate sperm during the study and for 3 months after the last dose.

Who may not be able to join:

• People diagnosed with a specific type of leukemia called Burkitt's Leukemia.
• People who have recently received certain cancer treatments before the first dose, including:
  • A small-molecule targeted therapy within the past 2 weeks or 5 half-lives (whichever is longer).
  • A large-molecule targeted therapy or immune-modifying treatment within the past 3 weeks.
  • Radiation therapy or chemotherapy (other than certain treatments given directly into the spinal fluid or a steroid called dexamethasone) within the past 2 weeks.
  • Any experimental drug treatment within the past 4 weeks or 5 half-lives (whichever is shorter).
  • A live vaccine within the past 4 weeks.
  • An autologous (own cells) stem cell transplant within the past 6 weeks.
  • An organ transplant or donor stem cell transplant within the past 12 weeks.
• People with active graft-versus-host disease (a complication after a donor transplant) that is moderate to severe, or chronic graft-versus-host disease requiring ongoing treatment.
• People who have had another cancer within the past 5 years, unless it was a localised cancer that was fully treated and has been disease-free for 5 or more years (such as certain skin cancers, early bladder cancer, localised prostate cancer, or early-stage cervical or breast cancer in situ).
• People with active leukemia spread to the brain or spinal fluid, or other uncontrolled spread to the central nervous system, as judged by the treating doctor.
• People with a significant history of brain or nervous system conditions such as epilepsy, seizures, stroke, severe brain injury, or psychosis — or evidence of brain inflammation or blood vessel problems seen on a brain MRI scan.
• People with certain heart or cardiovascular conditions, including:
  • A recent heart attack or severe chest pain episodes.
  • A heart procedure (angioplasty or stenting) within the past 6 months.
  • Significant uncontrolled irregular heartbeat (note: controlled atrial fibrillation for over 30 days may be acceptable — confirm with trial site).
  • Severe heart failure (classified as stage III or higher).
  • Poor heart pumping function below the trial site's threshold, or below 50% if no threshold is set.
  • Abnormal heart rhythm readings on an ECG above specific limits (confirm with trial site).
  • An implanted defibrillator device.
  • Uncontrolled high blood pressure above specific levels (confirm with trial site).
• People with a known allergy to monoclonal antibody medicines or to immunoglobulin products.
• People who have previously received CD19-targeted therapy and who test positive for an immune reaction to the study drug (YK012) at screening.
• People who have had major surgery or a serious injury within 4 weeks before the first dose, or who are expected to need planned surgery during the study, if side effects from that surgery have not sufficiently resolved.
• People who have been regularly taking steroid medicines (such as prednisone above a low daily dose) within the past 4 weeks, or who are expected to need higher doses during the trial, or who have taken other immune-suppressing medicines within the past 4 weeks.
• People with active hepatitis B virus infection at certain detectable levels, active hepatitis C virus infection at certain detectable levels, or a positive HIV test result.
• People with an active, uncontrolled infection requiring antibiotic or antiviral treatment taken by mouth or through a drip.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that needs to be drained once a month or more often.
• Women who are pregnant or currently breastfeeding.
• People with a known mental health condition that may affect their ability to follow the study requirements, or those who have shown poor ability to comply with medical instructions.
• People with other serious health conditions, unusual lab results, or other circumstances that the trial doctor considers unsuitable for participation.

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