Status:
RECRUITING
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
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
Up to 75 years
Phase:
PHASE1
Brief 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 "...
Detailed Description
Patients will give the investigators blood to make CD19 CD28 (with and without CD137) chimeric receptor-T cells in the laboratory. These cells will be grown and frozen. To make the T cells, investigat...
Eligibility Criteria
Inclusion
- 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 limit normal
- AST \<1.5 × upper limit normal
- PT and APTT \<1.5 × upper limit normal
- Informed consent explained to, understood by and signed by patient/guardian (and donor, where applicable). Patient/guardian given copy of informed consent.
- TREATMENT
- Diagnosis of recurrent B-cell lymphoma 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.
- Age \<= 75 years. The first 3 patients treated on the study should be adults (\>= 18 years).
- Bilirubin less than 3 times the upper limit of normal.
- AST less than 5 times the upper limit of normal.
- Estimated GFR \> 50 mL/min
- Pulse oximetry of \> 90% on room air
- Karnofsky or Lansky score of \> 60%.
- Recovered from acute toxic effects of prior chemotherapy at least one week before entering this study. PD1/PDL1 inhibitors will be allowed if medically indicated.
- Available autologous or syngeneic activated peripheral blood T cell products (CD28ζ and CD28/CD137ζ) with more than or equal to 15% expression of CD19.CAR determined by flow cytometry.
- Life expectancy of greater than 12 weeks.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
- Patients or legal guardians must 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.
Exclusion
- PROCUREMENT
- Active infection requiring antibiotics.
- No history of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry.
- TREATMENT
- Currently receiving any investigational agents or received any tumor vaccines within the previous 6 weeks. (Note treatment with PD1/PDL1 inhibitors is allowed.)
- 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 or HTLV.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2036
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01853631
Start Date
February 1 2014
End Date
February 1 2036
Last Update
January 5 2026
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