CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies

2007-0635

Sometimes researchers change the DNA (genetic material in cells) of donated T cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves drawing blood from the patient, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject the changed T-cells into the body of the patient. The goal of this clinical research study is to learn if an investigational type of gene transfer can be given reliably and safely in patients with advanced B-cell lymphoma. B cells are a type of white blood cell that fights infection and disease. Lymphoma is a type of cancer that affects the immune system, including B cells. The gene transfer involves drawing blood, separating out T cells (white blood cells that fight infection and disease), changing the T cells' DNA (genetic material) in a specific way, and returning the changed T cells back to the body. Researchers want to learn the highest dose of the changed T cells that can be given safely. Researchers also want to learn how long the changed T cells remain in the participant's body, and if the changed T cells can reliably treat B-cell lymphoma. Finally, researchers want to learn if interleukin-2 (IL-2) can help the changed T cells last longer in the body.

2011-06-20

2020-04-23

2020-04-23

Completed

Early phase I

34

Inclusion Criteria: 1. Patients with a history of CD19+ lymphoid malignancies that are beyond first remission or primary refractory to treatment. 2. Age 18 to 75 years. 3. Zubrod performance 0-1 or Karnofsky greater than or equal to 80%. 4. Patient able to provide written informed consent. 5. Patient able to provide written informed consent for the long-term follow-up gene therapy study. 6. Eligibility at time of transplant conditioning regimen (criteria 6-13): Zubrod performance 0-1 or Karnofsky greater than or equal to 80%. 7. Left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease. 8. No symptomatic pulmonary disease. FEV1, FVC and DLCO \>/= 50% of expected, corrected for hemoglobin. 9. Serum creatinine \</= 1.8mg/dL or creatinine clearance \>/= 40 cc/min. 10. Adequate hepatic function, as defined by SGPT \<3 X upper limit of normal; serum bilirubin and alkaline phosphatase \<2 X upper limit of normal, or considered not clinically significant. 11. If positive Hepatitis B and/or Hepatitis C serology, discuss with Principal Investigator or designee and consider liver biopsy. 12. No pleural/pericardial effusion or ascites estimated to be \>1L. 13. Not breast feeding or pregnant. Pregnancy determined by a positive beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. 14. Eligibility at time of T-cell infusion (criteria 14-15): No systemic corticosteroids within 3 days prior to T-cell infusion. 15. Not experiencing any new Grade \>2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to T-cell infusion. 16. Eligibility criteria for administration of IL-2 after T-cell infusion: Absence of new adverse event of grade \>2 (CTC vs. 4) involving cardiopulmonary, hepatic (excluding albumin), gastrointestinal, neurologic, or renal toxicity probably or definitely attributed to infused T cells within one week of cells. Exclusion Criteria: 1. Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. 2. Patients with known allergy to bovine or murine products. 3. Positive serology for HIV.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}

2023-12-19