Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan Rogel Cancer Center

About this trial

This phase I trial tests the safety and effectiveness of pomalidomide after CD19 chimeric antigen receptor T-cell (CD19CART) therapy for the treatment of patients with CD19+ B-cell leukemias or lymphomas that have come back after a period of improvement (relapsed) or do not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells and are then re-infused into the patient. Following CAR T-cell infusion, CAR T-cells must expand and persist in the blood stream in order to most effectively treat leukemia/lymphoma. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Research has shown that drugs like pomalidomide can modify the immune system and increase the number or improve the function of CAR T-cells in the blood. Pomalidomide may enhance the treatment effects of CAR T-cell therapy in patients who have received CD19CART therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma.

Eligibility criteria

Qualifiers

Subject must have had a histologically or cytologically confirmed R/R CD19+ B-cell leukemia or lymphoma and have received a commercially available CAR-T product approved to treat R/R CD19+ Bcell leukemias and lymphomas.

Subject must be 28 - 56 days post infusion of CD19CART product at time of enrollment.

>= 18 years in age at time of enrollment

Subject is able to swallow pills/tablets

Disqualifiers

Patients with known progressive or refractory disease.

Active grade >= 2 acute or chronic graft versus host disease (GVHD)

Active cytokine release syndrome (CRS) grade >= 2

Active immune effector cell associated neurotoxicity (ICANS) grade >= 2

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Pomalidomide

Treatment groups

12 Participants
are divided into 1 treatment group