Health Trials

CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies

ConditionsRecurrent B-Cell Non-Hodgkin LymphomaRecurrent Chronic Lymphocytic LeukemiaRecurrent Small Lymphocytic LymphomaRecurrent Transformed Chronic Lymphocytic LeukemiaRefractory B-Cell Non-Hodgkin LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Small Lymphocytic LymphomaRefractory Transformed Chronic Lymphocytic Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

This phase I trial studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. Some T cells are removed from the blood, and then laboratory, researchers will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat cancer. The new modified T cells are called the IC19/1563 treatment. IC19/1563 may help treat patients with relapsed/refractory B cell malignancies.

Eligibility criteria

Qualifiers

Age >= 18 years

Two or more prior lines of therapy, at least one anthracycline containing regimen, unless intolerable. Exception: Patients with Richter transformation of CLL are eligible if they had >= one prior treatment, including prior BTK inhibition

Demonstration of progressive or stable disease by positron emission tomography/computed tomography (PET/CT) or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano Response Criteria for Malignant Lymphoma.

Measurable disease defined as measurable by CT portion of a PET/CT: To be considered measurable, the must be at least one lesion that has a single diameter of (>1.5 cm Note: Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy

Disqualifiers

Pregnant persons

Nursing persons

Women of childbearing potential who are unwilling to employ highly effective contraception

Sexually active males who are not willing to use contraception during the study and for >= 12 months after IC19/1563 therapy

Trial design

Treatments tested in this trial

  • Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563
  • Bendamustine
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Cyclophosphamide
  • Fludarabine
  • Magnetic Resonance Imaging
  • Positron Emission Tomography

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov