Early Phase 1 Myeloma 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 take part and have signed a consent form agreeing to participate.
• People who have been diagnosed with a cancer of the B-cells or plasma cells (types of white blood cells), such as B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, multiple myeloma, or similar blood cancers, based on 2017 WHO diagnostic standards.
• People whose cancer has not responded to standard treatment, or has come back after a period of remission.
• People with B-cell acute lymphoblastic leukemia who have achieved blood cancer remission but still have small amounts of cancer detectable by sensitive tests (called minimal residual disease).
• People with relapsed or treatment-resistant lymphoma who have at least one measurable tumour area of 1.5 cm or larger in its longest dimension.
• People aged 18 years or older, of any gender.
• People with a life expectancy of at least 12 weeks.
• People whose liver and kidney function blood test results fall within acceptable ranges as defined by the trial (confirm specific values with the trial site).
• People whose blood cell counts meet the trial's minimum levels, unless their cancer has spread to the bone marrow, in which case no minimum blood count is required (confirm with trial site).
• People with a general health and activity level rated as 0, 1, or 2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site).
• People whose heart pumping function (left ventricular ejection fraction) is at least 50% and who have no fluid around the heart.
• People who have had at least two weeks pass since their last cancer treatment, including radiation, chemotherapy, antibody therapy, or other treatments.

Who may not be able to join:

• People with known allergies or serious reactions to the CAR-T cell therapy used in this trial or to any of the associated medications, including fludarabine, cyclophosphamide, or rituximab.
• People who have relapsed after a bone marrow or stem cell transplant from a donor and are currently experiencing graft-versus-host disease (where the donor cells attack the body) that requires steroid or immune-suppressing treatment.
• People with a serious, active infection at the time of the trial.
• People with an immune system deficiency, whether present from birth or developed over time.
• People with significant heart failure classified as Class III or IV (meaning the heart is severely limited in its ability to function during normal or minimal activity).
• People with a history of epilepsy or other diseases of the brain or nervous system.
• People whose lymphoma has spread to the brain, lungs, or digestive tract.
• People with another type of cancer, with the exception of certain skin cancers that have been fully removed by surgery, or certain early-stage cancers (such as cervical, bladder, or breast) that have been fully treated and cured.
• People who have received high-dose steroid treatment throughout the body within the two weeks before starting the trial.
• People who are pregnant, breastfeeding, or planning to become pregnant within six months.
• People who have taken part in another clinical trial within the past month.
• People whose situation the trial doctors consider may create additional risks or affect the reliability of the trial results (confirm with trial site).

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