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

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05110742

This Phase I/II trial evaluates the safety and efficacy of CAR.5/IL15-transduced CB-NK cells in relapsed/refractory hematological malignancies. It aims to determine optimal dosing and assess response rates. Interventions include IV administration of Fludarabine Phosphate, Cyclophosphamide, and CAR.5/IL15-transduced CB-NK cells. Eligibility criteria focus on specific hematological conditions.

Patient Parameters

Program Overview

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.

Description

Primary objective:

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.

Secondary Objectives:

  • To assess the overall response rate (complete and partial response rates)
  • To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in -To conduct comprehensive immune reconstitution studies.

Eligibility Criteria

Exclusion Criteria

  1. Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
  2. Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.
  3. Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.
  4. Active hepatitis B or C.
  5. HIV with detectable viral load
  6. Presence of active neurological disorder(s).
  7. Active autoimmune disease within 12 months of enrollment
  8. Active cerebral or meningeal involvement by the malignancy
  9. Active (defined as requiring therapy) acute or chronic GVHD
  10. Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.
  11. Presence of any other serious medical condition that may endanger the patient at investigator criteria
  12. Major surgery <4 weeks prior to first dose of study drug
  13. Allogeneic SCT or DLI <12 weeks prior to first dose of study drug
  14. Concomitant use of other investigational agents.
  15. Concomitant use of other anti-cancer agents.
  16. Patients receiving systemic steroid therapy at time of enrollment (physiological substitutive doses are allowed), or have received ATG within 14 days or Campath within 28 days of enrollment.
  17. Patients receiving immunosuppressive therapy

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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