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

• Status: Completed
• Trial end date: 2017-08-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

Inclusion Criteria:

1. Patients with a history of B-CLL, who have received at least 2 lines of standard chemoimmunotherapy and have persistent disease.

2. Confirmed history of CD19 positivity by flow cytometry.

3. 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.

4. Karnofsky Performance Scale > 60%.

5. Absolute lymphocyte count >100/uL.

6. 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.

7. Able to provide written informed consent.

8. 18-80 years of age.

9. 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.

Exclusion Criteria:

1. 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.

2. Patients with known allergy to bovine or murine products.

3. Positive serology for HIV.

4. Presence of autoimmune phenomenon (AIHA, ITP) requiring steroid therapy.

5. Presence of Grade 3 or greater toxicity from the previous treatment.

6. Concomitant use of other investigational agents (ibrutinib or lenalidomide are allowed).