M.D. Anderson Cancer Center
To find a recommended dose of donated NK cells that can be given with lymphodepleting chemotherapy to patients with advanced renal cell carcinoma, mesothelioma, or osteosarcoma. The effects of this therapy will also be studied.
Advanced Renal Cell Carcinoma
Advanced Mesothelioma
Advanced Osteosarcoma
CAR.70/IL15-transduced CB-derived NK cells
Fludarabine phosphate
Cyclophosphamide
Phase 1
Phase 2
Primary Objective: To determine the safety and optimal cell dose of chimeric antigen receptor (CAR).70/interleukin (IL)15-transduced cord blood (CB)-derived natural killer (NK) cells in patients with advanced renal cell carcinoma, advanced mesothelioma, and advanced osteosarcoma. To determine the antitumor activity of CAR.70/IL15-transduced CB-derived NK cells. Although the clinical benefit of CAR.70/IL15-transduced CB-derived NK cells has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit and thus, the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Efficacy will be determined in each of the three cohorts. Secondary Objectives: To quantify the persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient. To conduct comprehensive immune reconstitution studies. To obtain preliminary data on quality of life and patient experience.}}
Study Type : | Interventional |
Estimated Enrollment : | 50 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Phase I/II Study of CAR.70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma, Mesothelioma and Osteosarcoma |
Actual Study Start Date : | March 29, 2023 |
Estimated Primary Completion Date : | September 30, 2025 |
Estimated Study Completion Date : | September 30, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Chemotherapy and NK Cell Infusion Participants will be assigned to a dose level of NK cells. A computer will decide by chance which of the dose level you will receive, and this will not be based on the doctor's or patient's decision. Up to 5 dose levels of NK cells will be tested. Each new patient will receive a different dose. If any dose shows to be not tolerable, this dose and the higher doses will not be given anymore. |
Drug: CAR.70/IL15-transduced CB-derived NK cells Drug: Fludarabine phosphate Drug: Cyclophosphamide |
Ages Eligible for Study: | 18 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
M D Anderson Cancer Center
Houston, Texas, United States, 77030