Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Aggressive T Cell Hematological Malignancies

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorM.D. Anderson Cancer Center

About this trial

To determine the safety and efficacy (1-year PFS) of iC9/CD5CAR/IL-15 NK cells as consolidation in patients with aggressive T-cell malignances in first remission.

Eligibility criteria

Qualifiers

18-80 years of age

Patients with hematological malignancies with an expression of CD5 in the tumor sample of ≥ 30% measured by immunohistochemistry or flow cytometry.

Patients must meet disease-specific eligibility criteria.

Patients should be at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least three days prior to administration of lymphodepleting chemotherapy.

Disqualifiers

Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.

Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.

Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.

Active hepatitis B or C.

Trial design

Treatments tested in this trial

  • C9/CD5CAR/IL-15 NK cells
  • Rituximab
  • Fludarabine
  • Cyclophosphamide

Treatment groups

70 Participants
are divided into 1 treatment group

Sponsors and collaborators