CD19-specific T-cell for Chronic Lymphocytic Leukemia (CLL)

Completed · Phase 1

Conditions studied: Advanced Cancers, Leukemia

In brief

The goal of this clinical research study is to find the highest tolerable dose of T cells that can be given in combination with standard chemotherapy to patients with CLL. The safety of this combination will also be studied. The T cells being used in this study are a type of white blood cell that will be taken from your blood and then genetically changed in a laboratory. The process of changing the DNA (the genetic material of cells) of the T cells is called a gene transfer. After the gene transfer is complete, the genetically changed T-cells will be put back into your body. These T cells may help prevent cancer cells from coming back.

Key facts

Study ID

NCT01653717

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2013-06-11

Expected to finish

2017-08-07

Last updated by the study team

2017-08-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a history of B-CLL, who have received at least 2 lines of standard chemoimmunotherapy and have persistent disease.
• Confirmed history of CD19 positivity by flow cytometry.
• At least 8 weeks from last cytotoxic chemotherapy. Patients may continue ibrutinib or lenalidomide. These drugs will be discontinued 1 week prior to start of lymphodepleting chemotherapy.
• Karnofsky Performance Scale > 60%.
• Absolute lymphocyte count >100/uL.
• Adequate hepatic function, as defined by serum glutamate pyruvate (SGPT) <3 x upper limit of normal; serum bilirubin and alkaline phosphatase <2 x upper limit of normal, or considered not clinically significant by the study doctor or designee.
• Able to provide written informed consent.
• 18-80 years of age.
• Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent for the long-term follow-up gene therapy study.

You may not qualify if…

• Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females.
• Patients with known allergy to bovine or murine products.
• Positive serology for HIV.
• Presence of autoimmune phenomenon (AIHA, ITP) requiring steroid therapy.
• Presence of Grade 3 or greater toxicity from the previous treatment.
• Concomitant use of other investigational agents (ibrutinib or lenalidomide are allowed).

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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