Status:
ACTIVE_NOT_RECRUITING
T-cells or EBV Specific CTLs, Advanced B-Cell NHL and CLL
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma or chronic Lymphocytic Leukemia. Their lymphoma or CLL has come back or has not gone away after treatment. Because ...
Detailed Description
The patient or their donor will give us blood to make CD19-CD28 chimeric receptor T cells and CD19 chimeric-EBV specific T cells in the laboratory. These cells are grown and frozen for the patient. Be...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- FOR TREATMENT:
- Recurrent low or intermediate grade B-cell lymphoma or B-CLL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory intermediate B cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation.
- CD19-positive tumor
- EBV seropositivity (in patient and donor, as applicable)
- Recovered from the acute toxic effects of all prior chemotherapy at least a week before entering this study.
- Not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six weeks.
- No treatment with rituximab within the previous 8 weeks.
- ANC \> 500, Hgb \> 8.0\*
- Bilirubin less than 3 times the upper limit of normal\*
- AST less than 5 times the upper limit of normal\*
- Serum creatinine less than 3 times upper limit of normal\*
- Pulse oximetry of \> 90% on room air\*
- Adequate pulmonary function with FEV1, FVC and DLCO \>35%\* of expected corrected for hemoglobin
- Karnofsky or Lansky score of \> 60%.
- Available autologous or syngeneic transduced EBV-specific cytotoxic T lymphocytes and peripheral blood T-cells with 15% or greater expression of CD19CAR determined by flow-cytometry.
- Patients or legal guardians must understand and sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.
- EXCLUSION CRITERIA:
- History of hypersensitivity reactions to murine protein-containing products.
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction.
- Active infection with HIV, HBV, HCV or CMV.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00709033
Start Date
July 1 2009
End Date
April 1 2027
Last Update
February 5 2025
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030