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:

• People who have been diagnosed with a recurring T-cell blood or lymph node cancer, specifically one of these types: T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or certain types of T-cell non-Hodgkin lymphoma (including AITL, EATL, MEITL, PTCL, ALCL, Adult T-cell leukemia/lymphoma, T-cell prolymphocytic leukemia with symptoms, Extranodal NK/T cell lymphoma, or Mycosis fungoides/Sézary Syndrome at Stage IIB or higher).
• People whose cancer cells have tested positive for a protein called CD5, with more than 50% of cancer cells showing this marker on laboratory testing.
• People who are 75 years old or younger (note: the first six patients treated in the study must be adults over 18 years of age).
• People whose doctors expect them to live for more than 12 weeks.
• People who are considered suitable for a stem cell transplant from a donor, where an eligible donor has already been identified through an accredited institution, and where the trial centre plans to proceed with the transplant if the experimental treatment produces a complete remission.
• People whose cancer has come back after a previous donor stem cell transplant (Group B), and whose original stem cell donor is available for this study.
• People who have access to a partially-matched donor T-cell line through a Baylor College of Medicine approved process, which could be used if a certain viral infection (EBV) becomes uncontrolled (confirm with trial site).
• People with a haemoglobin level of at least 7.0 g/dL (this can be achieved through a blood transfusion).
• People whose liver function, kidney function, and blood clotting results are within acceptable ranges if a blood collection procedure (pheresis) is needed.
• People whose liver measurements (bilirubin and AST) and kidney function (estimated GFR above 60 mL/min) meet the required levels at the time of treatment.
• People whose blood oxygen level is above 90% while breathing normal air.
• People who have a performance score (a measure of how well a person can carry out daily activities) of at least 60% on the Karnofsky or Lansky scale.
• People who have recovered from the side effects of any previous chemotherapy for at least one week before joining.
• People who are at least 60 days past their previous donor stem cell transplant at the time of treatment.
• People who are sexually active and are willing to use effective contraception during the study and for 6 months after it ends; male partners must use a condom.
• People who have given their informed consent, or whose guardian has done so on their behalf.

Who may not be able to join:

• People who currently have an active infection that requires antibiotic treatment (at the procurement stage).
• People who have an active HIV infection.
• People who have a history of another cancer (other than non-melanoma skin cancer, or in-situ breast or cervical cancer) unless that cancer was successfully treated with the intent to cure at least 2 years before joining the trial.
• People who are currently receiving another experimental treatment, or who have received a cancer vaccine within the past 6 weeks.
• People who have had an allergic reaction to products containing mouse-derived proteins in the past.
• People who are pregnant or breastfeeding.
• People whose tumour is located in a place where swelling could block the airway.
• People who have a significant active viral infection, or an uncontrolled reactivation of certain viruses including EBV, CMV, adenovirus, BK virus, or HHV-6.
• People who have moderate to severe graft-versus-host disease (a complication where donor cells attack the body) that is active or not well controlled.
• People who are currently taking steroid medications (such as prednisone) at doses above 0.5 mg/kg to treat graft-versus-host disease.
• People who have received immune-suppressing treatment for graft-versus-host disease within the 28 days before the planned infusion.
• People who have received a donor lymphocyte infusion (a type of immune cell treatment from a donor) within 28 days before the planned infusion.
• People with certain significant heart conditions, including irregular heart rhythm (atrial fibrillation/flutter), a heart attack within the past 12 months, certain electrical abnormalities in the heart, significantly reduced heart pumping function, a fluid build-up around the heart, or heart failure classified as NYHA Grade III or IV.
• People with certain nervous system conditions, including active cancer in the fluid surrounding the brain and spine (CNS-3 disease), uncontrolled seizures, a stroke or brain bleed within the past 6 months, dementia, disease of the cerebellum, or an autoimmune disease affecting the brain or nervous system.

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