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SAGAN Study: CD19-Specific CAR T-Cells for Lymphoma and Leukemia

This study is testing a new way to fight certain blood cancers like Non-Hodgkin Lymphoma, Acute Lymphocytic Leukemia, and Chronic Lymphocytic Leukemia that have returned or not responded to previous treatments. Researchers are using your own T-cells (a type of white blood cell that fights infection) and modifying them in the lab. These modified T-cells, called CD19.CAR/28 and CD19.CAR/28137 T cells, are designed to better recognize and kill cancer cells. The study will look at different doses of these modified T-cells to see how safe they are and how well they work. You may be eligible if you are between 0 and 75 years old and have one of these types of lymphoma or leukemia.

Study design
This study is an interventional study with a planned enrollment of 64 participants. It involves a dose escalation phase to evaluate three different dose levels of the modified T-cells, followed by an expansion phase.
What's involved
You will provide blood for the creation of the modified T-cells. After receiving the T-cell infusion, you will be followed for a total of 15 years to monitor for long-term side effects.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for a total of 15 years after receiving the T-cell infusion to monitor for long-term side effects of gene transfer.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01853631

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

Recruiting
PHASE1Up to 75InterventionalTreatment
Baylor College of Medicine
~64 participants
Updated 2026-01-05 on ClinicalTrials.gov
What's tested:Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cellsExpansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with dose limiting toxicity (DLT)
Measured over 6 weeks

Conditions

Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Acute Lymphocytic Leukemia

Explore related trials

Acute Lymphoblastic LeukemiaAggressive B-cell LymphomaChronic Lymphocytic LeukemiaNon-Hodgkin LymphomaCD19 Gene

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Carlos A Ramos, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Carlos A Ramos, MD
[email protected]
832-824-4817
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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.
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.

What this trial measures

  • Number of patients with dose limiting toxicity (DLT)6 weeks

    Toxicity will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 4. DLT will be defined as any of the following that is NOT (1) pre-existing, or (2) due to infection (to which patients with CLL and NHL are predisposed), or (3) due to underlying malignancy, and that may, after consultation with the FDA when indicated, be considered possibly, probably, or definitely related to the study cellular products: (1) Non-hematologic DLT is any grade 3 or grade 4 non-hematologic toxicity, including allergic reactions to T cell infusions; (2) Hematologic DLT is defined as any grade 4 hematologic toxicity. Patients with evidence of bone marrow disease (metastases or diffuse infiltration) are not evaluable for hematologic dose limiting toxicity.