Actively Recruiting
NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors
Led by jianming xu · Updated on 2022-05-19
18
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
J
jianming xu
Lead Sponsor
K
KAEDI
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D-based CAR-T cells infusion in the treatment of advanced NKG2DL+ solid tumors.
CONDITIONS
Official Title
NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with advanced solid tumors such as ovarian, cholangiocarcinoma, or colorectal cancer confirmed by pathology or cytology
- Patients who have failed standard treatment, cannot tolerate standard treatment, or have no standard treatment according to NCCN or CSCO guidelines
- Age between 18 and 70 years
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Adequate coagulation parameters and peripheral venous access for apheresis with sufficient PBMC for CAR T cell manufacturing
- Positive NKG2DL expression confirmed by immunohistochemistry with a score of 2 or higher on tissue no older than 1 year or from recent biopsy
- Adequate organ and bone marrow function including neutrophil count, lymphocyte count, platelet count, hemoglobin, liver enzymes, creatinine or eGFR, coagulation tests, lung function, and cardiac ejection fraction
- Measurable lesions as defined by RECIST 1.1
- Ability to understand the study and provide informed consent
- Agreement to use approved contraceptive methods during the study and for 12 months after last cell infusion until CAR-T cells are undetectable
You will not qualify if you...
- Prior gene therapy including CAR-T cell therapy or T cell therapy
- Active uncontrolled bacterial, viral, or fungal infections including positive blood tests within 72 hours before infusion
- Positive tests for syphilis, HIV, active hepatitis B or C infections
- Autoimmune disease or organ transplant requiring chronic systemic steroids or immunosuppressive drugs
- History of serious heart or lung diseases including congestive heart failure class 3 or higher, recent cardiac interventions, unstable angina, or severe heart disease within past 6 months
- Clinically relevant central nervous system metastases or pathologies such as seizures, cerebral ischemia or bleeding, dementia, cerebellar or CNS autoimmune diseases
- History or evidence of neuroticism, psychosis, immunologic, metabolic, or infectious diseases or lab abnormalities that may interfere with study participation or outcomes
- History of hematologic malignancy or other malignant solid tumors except cervical or breast cancer in situ disease-free for over 3 years or resected tumor in situ disease-free for over 5 years
- Received chemotherapy, radiation, small molecule, biologic cancer therapy, immunotherapy, or experimental drugs within 4 weeks prior to study
- Pregnant or lactating women
- Medical, psychological, social, or geographic conditions deemed by investigator to interfere with study participation or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
J
Jianming Xu, M.D
CONTACT
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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