Actively Recruiting
NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-07-19
9
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
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...
- Diagnosed with advanced solid tumors confirmed by tissue examination, including ovarian, cholangiocarcinoma, or colorectal cancer
- Have failed standard treatment, cannot tolerate it, or no standard treatment exists according to current guidelines
- Aged between 18 and 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
- Expected survival of at least 3 months
- Meet coagulation and peripheral venous access requirements for cell collection
- Positive for NKG2DL marker confirmed by immunohistochemistry with a score of 2 or higher
- Adequate organ and bone marrow function as defined by specific blood counts and liver, kidney, lung, and heart function tests
- Have measurable tumors according to RECIST 1.1 criteria
- Understand the study and provide voluntary informed consent
- Agree to use approved contraception during the study and for 12 months after the last cell infusion until CAR-T cells are undetectable
You will not qualify if you...
- Prior gene therapy or CAR-T cell therapy
- Active uncontrolled bacterial, viral, or fungal infections
- Positive for syphilis, HIV, active hepatitis B or hepatitis C with high viral load
- Autoimmune disease, organ transplant, or requiring chronic immunosuppressive therapy
- Serious heart or lung diseases or events within the past 6 months such as severe heart failure or myocardial infarction
- Central nervous system metastases or neurological diseases affecting the brain
- Psychiatric or other medical conditions that could interfere with study participation or outcomes
- History or current evidence of blood cancers or other malignant solid tumors except certain treated cancers with no evidence of disease
- Received chemotherapy, radiation, biologic therapy, immunotherapy, or experimental drugs within 4 weeks before the study
- Pregnant or breastfeeding women
- Any condition or circumstance that the investigator believes would interfere with full participation or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
N
Ning Li, MD
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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