Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)

Launched by BAYLOR COLLEGE OF MEDICINE · May 9, 2013

Keywords

ClinConnect Summary

The SAGAN clinical trial is studying a new treatment approach for patients with certain types of blood cancers, specifically Non-Hodgkin Lymphoma, Acute Lymphocytic Leukemia (ALL), and Chronic Lymphocytic Leukemia (CLL). This trial is testing a method that combines special immune cells called T cells with an antibody that targets a protein found on many cancer cells, known as CD19. By enhancing the T cells in the lab and combining them with this antibody, researchers hope to create a stronger defense against the cancer cells that have come back or have not responded well to previous treatments.

To be eligible for this trial, participants need to be adults up to 75 years old with a confirmed diagnosis of recurrent B-cell lymphoma or leukemia. They should have a specific type of tumor that expresses the CD19 protein and must have recovered from any recent chemotherapy. During the trial, participants will receive either the new treatment or a variation of it, and the researchers will closely monitor their health, looking for side effects and assessing how well the treatment works. This research could potentially lead to improved treatment options for patients with these challenging blood cancers.

Gender

ALL

Eligibility criteria

• 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 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 Criteria:
• • 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.