Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To determine the safety, efficacy and optimal cell dose of CAR 5/IL15-transduced CB-NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases.

Eligibility criteria

Qualifiers

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

Patients must meet diseases specific eligibility criteria (see below)

Patients should be at least 1 weeks 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.

Localized radiotherapy to one or more disease sites are allowed prior the infusion provided that there are additional disease sites that are not irradiated.

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

  • Fludarabine Phosphate
  • Cyclophosphamide
  • CAR.5/IL15-transduced CB-NK cells

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators