Health Trials

Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies

ConditionsRecurrent Acute Lymphoblastic LeukemiaRecurrent B Acute Lymphoblastic LeukemiaRecurrent B-Cell Prolymphocytic LeukemiaRecurrent Chronic Lymphocytic LeukemiaRecurrent High Grade B-Cell LymphomaRecurrent Indolent Non-Hodgkin LymphomaRecurrent Non-Hodgkin LymphomaRecurrent Transformed Chronic Lymphocytic LeukemiaRefractory Acute Lymphoblastic LeukemiaRefractory B Acute Lymphoblastic LeukemiaRefractory B-Cell Prolymphocytic LeukemiaRefractory Chronic Lymphocytic LeukemiaRefractory High Grade B-Cell LymphomaRefractory Indolent Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaRefractory Transformed Chronic Lymphocytic LeukemiaRefactory Childhood Acute Lymphoblastic LeukemiaRefractory Childhood Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2+
SponsorSumithira Vasu

About this trial

This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19/CD20/CD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malignancies) that have come back (recurrent) or do not respond to treatment (refractory). Lymphoid malignancies eligible for this trial are: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-prolymphocytic leukemia (B-PLL). T-cells (a type of white blood cell) form part of the body's immune system. CAR-T is a type of cell therapy that is used with gene-based therapies. CAR T-cells are made by taking a patient's own T-cells and genetically modifying them with a virus so that they are recognized by a group of proteins called CD19/CD20/CD22 which are found on the surface of cancer cells. Anti-CD19/CD20/CD22 CAR T-cells can recognize CD19/CD20/CD22, bind to the cancer cells and kill them. Giving combination chemotherapy helps prepare the body before CAR T-cell therapy. Giving CAR-T after cyclophosphamide and fludarabine may kill more tumor cells.

Eligibility criteria

Qualifiers

Adult subjects with relapsed or refractory non-Hodgkin lymphoma with lesions =< 5 cm, indolent lymphomas, chronic lymphocytic leukemia without Richter's transformation, or B-prolymphocytic leukemia (Cohort A)

OR adult subjects with lymphoid blast crisis, acute lymphoblastic leukemia, chronic lymphocytic leukemia with Richter's transformation, non-Hodgkin lymphoma with lesions > 5 cm and/or lymphoblastic lymphoma, or non-Hodgkin lymphoma with circulating lymphoma cells, B-Prolymphocytic leukemia with lesions > 5 cm (not including splenomegaly (Cohort B).

OR Pediatric subjects with Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

Subjects must have been treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve complete remission with the last regimen. B-PLL is defined as having greater than 55% prolymphocytes in the peripheral blood

Disqualifiers

Autologous transplant within 6 weeks of planned CAR-T cell infusion

Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months of planned CAR-T cell infusion and patients must be off immunosuppressive agents. Patients with live vaccines given 28 days prior to lymphodepletion (LD) chemotherapy will be excluded

Active graft versus host disease

Active central nervous system or meningeal involvement by lymphoma or leukemia. Subjects with untreated brain metastases/central nervous system (CNS) disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast-enhanced magnetic resonance imaging (MRI) imaging for at least 90 days prior to registration

Trial design

Treatments tested in this trial

  • Anti-CD19/CD20/CD22 CAR T-Cells
  • Cyclophosphamide
  • Fludarabine Phosphate
  • Echocardiography
  • Multigated Acquisition Scan
  • Biopsy
  • Pheresis
  • Bone Marrow Aspiration and Biopsy
  • Biospecimen Collection

Treatment groups

54 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Sumithira Vasu

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov