Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL,
Subjects on this study have a type of lymph gland cancer called Non-Hodgkin Lymphoma, acute lymphocytic leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "lymphoma" or "leukemia"). The lymphoma or leukemia has come back or has not gone away after treatment. The body has different ways of
| Condition(s) | Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Acute Lymphocytic Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Subjects on this study have a type of lymph gland cancer called Non-Hodgkin Lymphoma, acute lymphocytic leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "lymphoma" or "leukemia"). The lymphoma or leukemia has come back or has not gone away after treatment. The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, hoping that they will work together. Both antibodies and T cells have been used to treat patients with cancer. They have shown promise, but have not been strong enough to cure most patients. T cells can kill tumor cells but normally there are not enough of them to kill all the tumor cells. Some researchers |
| Who can participate | Inclusion Criteria: PROCUREMENT Referred patients (or respective donors) will initially be consented for procurement of blood for generation of the transduced ATL. Eligibility criteria at this stage include: * Diagnosis of recurrent B-cell lymphoma or leukemia (ALL or CLL), or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory aggressive B-cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation. * CD19-positive tumor (result can be pending at this time). * Age \<= 75 years. The first 3 patients treated on the study should be adults (\>= 18 years). * Hgb greater than or equal to 7.0 (can be a transfused value) * If pheresis required to collect blood: * Creatinine \< 1.5 x upper |
| Ages | 75 Years |
| Sex | All |
| Lead sponsor | Baylor College of Medicine |
| Locations | Houston, Texas, United States; Houston, Texas, United States |
| Start date | 2014-02 |
| NCT ID | NCT01853631 |
| Official listing | https://clinicaltrials.gov/study/NCT01853631 |