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:

• People diagnosed with certain blood cancers — specifically CD19-positive B-cell lymphoma (including Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukaemia, Marginal Zone Lymphoma, or Lymphoplasmacytic Lymphoma) or B-cell Acute Lymphoblastic Leukaemia (B-ALL) — where no curative treatment is currently available and life expectancy is estimated at less than 2 years. The trial may also be used as a step before a stem cell transplant.
• People whose blood test shows a sufficient number of a specific type of immune cell (CD3 count above 200 per microlitre), as confirmed by flow cytometry.
• People with lymphoma who have already tried at least 2 rounds of standard treatment (each round lasting at least 2 cycles of chemotherapy-based therapy), or people with B-ALL who have tried at least 1 round of treatment or whose cancer did not respond to first-line treatment.
• People with a type of lymphoma that has transformed from a slower-growing form, provided at least one full treatment course (minimum 2 cycles) has been completed for the transformed disease.
• People whose cancer cells have been confirmed to carry a protein called CD19, shown on a tissue or blood sample taken at any point during prior treatment.
• People who are not eligible to receive the commercially available CAR T-cell therapy for CD19.
• People with lymphoma who still have measurable or detectable disease (people whose cancer is in complete remission with no sign of disease are not eligible).
• People with B-ALL who have measurable detectable disease confirmed on two separate occasions at least 2 weeks apart.
• People who have relapsed more than 100 days after a stem cell transplant (autologous or allogeneic). Those who received a donor stem cell transplant must have been off all immune-suppressing medications for at least 4 weeks before the cell collection procedure, and must have no active graft-versus-host disease.
• People aged 18 years or older and under 80 years of age.
• Women who could become pregnant must have a negative pregnancy test and must use an accepted form of contraception (such as abstinence, barrier methods, Depo-Provera, or oral contraceptives) for at least one year after receiving the CAR T-cell treatment.
• Men must be willing to use contraception from the time of enrolment until at least 6 months after receiving the preparative treatment.
• People whose heart is pumping at least 45% of its normal capacity, as confirmed by a cardiac imaging test (MUGA scan or echocardiogram).
• People who do not need supplemental oxygen, do not have breathlessness at rest, and whose lung function tests are at least 65% of the expected normal level.
• People with a performance score of 70 or above on the Karnofsky scale, which measures general health and ability to carry out daily activities (confirm with trial site).
• People whose expected survival is more than 12 weeks.
• People who are able to understand the risks and procedures involved in the trial and can give their own informed consent to participate.
• People who agree to have their anonymous data shared with an international transplant research registry (CIBMTR).

Who may not be able to join:

• People with HIV infection where the virus is actively replicating. People with HIV who have an undetectable viral load while on antiretroviral treatment may be considered (confirm with trial site).
• People with active hepatitis B infection where the virus is actively replicating.
• People with active hepatitis C infection where the virus is actively replicating.
• People with active, untreated cancer that has spread to the brain or spinal fluid. People whose brain or spinal fluid involvement has been treated and is no longer active may be considered, but must have two clear spinal fluid tests and two brain scans showing no disease progression, each taken at least 4 weeks apart.
• People with an active bacterial, fungal, or viral infection.
• People who have a second cancer that currently requires active treatment. People with breast or prostate cancer that is stable on hormonal therapy may be considered if otherwise well enough (confirm with trial site).
• People who have had a heart attack within the past 6 months, or who have symptomatic heart valve or coronary artery disease, or an uncontrolled irregular heartbeat.
• People who have used an experimental drug within 30 days before the cell collection procedure (leukapheresis).
• People who have received any anti-cancer treatment within 4 weeks before the cell collection procedure, including treatments targeting CD19, certain antibody therapies, bispecific T-cell engager therapy, or targeted drugs such as BTK inhibitors, venetoclax, lenalidomide, or similar medications.
• People who have had radiation therapy within 14 days before the cell collection procedure. Radiation that ended at least 15 days beforehand and caused only mild or no side effects may be acceptable (confirm with trial site).
• People who have received checkpoint inhibitor therapy (a type of immunotherapy) within 4 weeks before the cell collection procedure.
• People who have been taking corticosteroids at a dose higher than 10 mg of prednisone (or equivalent) within 4 weeks before the cell collection procedure.
• People who are taking immune-suppressing medications that cannot be safely stopped for at least 4 weeks before the cell collection procedure, as determined by their prescribing doctor.
• People whose blood test results show significantly abnormal liver, kidney, or blood cell function, based on specific laboratory thresholds (confirm details with trial site).
• People who are pregnant or breastfeeding.
• People who, in the investigator's opinion, are unlikely to be able to follow the study schedule or procedures.
• People who belong to a vulnerable group — such as those who are homeless, have a developmental disability, or are incarcerated — or anyone whose circumstances affect their ability to give informed consent or follow the study requirements.

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