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

Description

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.

Conditions

Hematological Malignancy

Study Overview

Study Details

Study 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.

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

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

Condition
Hematological Malignancy
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

chitra hosing, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2027-12-30