Actively Recruiting
Phase I/II Study of CAR.70-engineered IL15-transduced Cord Blood-derived NK Cells with Lymphodepleting Chemotherapy for Advanced Renal Cell Carcinoma, Mesothelioma, and Osteosarcoma
Led by M.D. Anderson Cancer Center · Updated on 2026-03-04
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new treatment using genetically engineered natural killer (NK) cells derived from donated cord blood, combined with lymphodepleting chemotherapy. This study focuses on patients with advanced renal cell carcinoma, mesothelioma, or osteosarcoma. The main goals are to find a safe and effective dose of these CAR.70/IL15-transduced NK cells and to evaluate their effects on tumors and patients' quality of life. Participants will receive lymphodepleting chemotherapy with fludarabine phosphate and cyclophosphamide given intravenously, followed by an infusion of the engineered NK cells. Up to five different dose levels of NK cells will be tested, and each participant will be randomly assigned to one dose level. If any dose shows intolerance, that dose and higher doses will no longer be given. During the study, participants will be closely monitored for safety and side effects using standard criteria for adverse events over about one year. Researchers will also assess tumor response, immune system changes, and patient experience, including quality of life. Consent includes agreement to long-term follow-up. The study is open to adults aged 16 to 80 years with specific advanced cancers expressing the CD70 marker.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced clear cell renal cell carcinoma, osteosarcoma, or mesothelioma with CD70 expression meeting study thresholds
- Meet disease-specific criteria including measurable disease and prior treatments
- At least 2 weeks since last chemotherapy or targeted therapy
- At least 3 months since any prior cell therapy
- Localized radiotherapy allowed if additional measurable disease present
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate organ function as defined by kidney, liver, heart, lung, blood, and coagulation parameters
- Able to provide informed consent and pediatric assent if applicable
- Aged 16 to 80 years
- Weight at least 40 kg
- Use effective birth control during and for 3 months after study therapy if able to have children
- Negative pregnancy test for females of childbearing potential
- Signed consent to long-term follow-up
You will not qualify if you...
- Ongoing significant toxicity from previous cancer treatments
- Active infections requiring IV treatment or not responding to therapy
- Known active hepatitis B or C
- Detectable HIV viral load or antiretroviral drug conflicts
- Active neurological disorders
- Autoimmune disease within past 12 months (except certain controlled conditions)
- Amyloidosis or POEMS syndrome
- Symptomatic or uncontrolled central nervous system involvement
- Other recent or active malignancies that interfere with participation
- Serious heart conditions or recent major cardiac events
- Severe aortic stenosis or uncontrolled arrhythmia without approval
- Prolonged QTc interval on ECG
- Major surgery within 4 weeks prior to chemotherapy
- Use of other investigational or anticancer agents
- Previous anti-CD70 therapy
- Systemic steroid therapy above allowed doses
- Recent use of antithymocyte globulin or Campath
- Immunosuppressive therapy
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Several days prior to NK cell infusion
Participants receive lymphodepleting chemotherapy with fludarabine phosphate and cyclophosphamide before the NK cell infusion.
Multiple visits for chemotherapy administration
Duration - Single infusion with monitoring post-infusion
Participants receive an infusion of CAR.70/IL15-transduced cord blood-derived NK cells at assigned dose levels to treat their advanced cancer.
1 infusion visit plus several follow-up visits during treatment phase
Duration - Up to 1 year after treatment
Participants are monitored for safety, tolerability, tumor response, and immune reconstitution after the treatment.
Regular follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
David Hong, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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