This Phase I/II trial will test the effectiveness, safety, side effects, and best dose of CD19-targeted Chimeric Antigen Receptor (CAR) modified T cells genetically engineered to secrete interleukin 12 (IL-12) in patients with hematologic B-cell malignancies.
For patients with Recurrent or Refractory B-Cell malignancies, such as:
- Chronic lymphocytic lymphoma
- Transformed chronic lymphocytic lymphoma
- Diffuse large B-cell lymphoma
- High grade B-cell lymphoma
- Follicular lymphoma
- Transformed follicular lymphoma to diffuse large B-cell lymphoma
- Mantle cell lymphoma
About this Technology
“Armored” CAR T cells are a new generation of CAR T products that are being evaluated in clinical trials. This is the first trial anywhere that employs an IL-12 secreting CAR T-cell for leukemia or lymphoma. This enhanced type of immunotherapy was developed by our scientists at Roswell Park in collaboration with those at Memorial Sloan Kettering.
Current CAR T-cell therapies have been commercially available for seven years now and about 40% of patients have achieved long term remission and/or cure. With this trial we hope to see this next generation therapy benefit more patients, achieve longer remissions, and result in more cures.
Who is eligible?
Patients with refractory or recurrent B-cell malignancies that express CD-19 and have had two previous lines of therapy and have good functional status.
What your patients should know
This cutting-edge cellular therapy uses a patient’s own T cells which are engineered to combat their cancer.
- The actual delivery of the cells is a one-time infusion. However, preparation for this infusion involves several steps, including T cell collection by apheresis, lymphodepletion chemotherapy, and a x-day hospital stay.
- After T cell collection, modifying and multiplying the cells for the infusion treatment takes approximately 4-6 weeks and some patients may need bridge therapy with continued chemotherapy to control their disease during this time.
- Possible side effects include acute cytokine release syndrome. All patients are monitored closely with prompt intervention if necessary.
