Using modified T-cells to treat advanced B-cell cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on patients with advanced B-cell cancers, including Non-Hodgkin Lymphoma, Acute Lymphocytic Leukemia, and Chronic Lymphocytic Leukemia, who have not responded to previous treatments. The study involves extracting T-cells from the patient's blood, modifying them in the laboratory to express a CD19-specific chimeric antigen receptor (CAR), and then reintroducing these enhanced T-cells back into the patient. The goal is to improve the ability of the immune system to target and destroy cancer cells. Patients will be monitored for long-term effects of this gene therapy approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting
• Texas Children's Hospital
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Carlos A Ramos, MD — The Methodist Hospital Research Institute
• Study coordinator: Carlos A Ramos, MD
• Email: CARamos@houstonmethodist.org
• Phone: (713) 441-1450

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.