Actively Recruiting
A Single-center Open-label Study of KD-025 CAR-T Therapy for Advanced NKG2DL-positive Solid Tumors
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-07-19
9
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of KD-025, an NKG2D-based CAR-T cell infusion, in patients with advanced NKG2DL-positive solid tumors. This open-label Phase 1 study focuses on patients with advanced cancers such as ovarian, cholangiocarcinoma, and colorectal cancer who have not responded to standard treatments or have no available standard therapy. The study is conducted at a single center and aims to assess both safety and potential treatment effects of KD-025 cells. Participants will receive KD-025 cell injections following a screening process that includes preparation of the cell product and lymphodepleting chemotherapy before infusion. The study involves dose escalation and expansion phases to evaluate tolerability and efficacy. All subjects undergo pre-treatment, treatment, and a follow-up period to monitor responses and side effects. During the study, patients will have ongoing assessments including monitoring for adverse events, dose-limiting toxicities, and the presence of CAR-positive T cells up to six months after infusion. Researchers will also measure objective response rate, progression-free survival, overall survival, and complete remission at multiple time points up to one year. Safety monitoring continues throughout, with participation lasting according to the study protocol and follow-up schedule.
CONDITIONS
Brief 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 confirmed by pathology or cytology, such as ovarian, cholangiocarcinoma, and colorectal cancer
- Patients who have failed standard treatment, cannot tolerate standard treatment, or have no available standard treatment
- Age between 18 and 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival of at least 3 months
- Adequate blood clotting parameters and peripheral venous access for apheresis
- Positive NKG2DL expression confirmed by immunohistochemistry with a score of 2 or higher
- Eligible organ and bone marrow functions meeting specified blood count and liver, kidney, lung, and cardiac function criteria
- Measurable lesions as defined by RECIST 1.1
- Ability to understand the study and voluntarily sign informed consent
- Agreement to use approved contraceptive methods during the study and for 12 months after last infusion until CAR-T cells are undetectable
You will not qualify if you...
- Prior gene therapy or CAR-T cell therapy, uncontrolled active infections including bacteria, virus, or fungus
- Autoimmune disease or organ transplant requiring chronic steroid or immunosuppressive therapy
- History of serious heart or lung disease or recent severe cardiac events within 6 months
- Clinically relevant central nervous system metastases or neurological diseases affecting the CNS
- History or current conditions that could affect study outcomes or participation, including psychiatric or immunological disorders
- History of hematologic malignancy or concurrent other malignant solid tumors except certain treated cancers without evidence of disease
- Receipt of chemotherapy, radiation, immunotherapy, or experimental drugs within 4 weeks before study start
- Pregnant or lactating women
- Any condition or factor deemed by the investigator to interfere with study participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies based on preparation and chemotherapy schedule
Participants undergo cell product preparation and lymphodepleting chemotherapy before receiving the KD-025 cell infusion.
Multiple visits depending on cell preparation and chemotherapy requirements
Duration - Single infusion with follow-up assessments
Participants receive KD-025 cell infusion to treat advanced NKG2DL-positive solid tumors.
1 infusion visit (in-person)
Duration - Up to 1 year after infusion
Participants are monitored for safety and efficacy outcomes including adverse events and tumor response after the KD-025 cell infusion.
Visits at 1 month, 2 months, 3 months, 6 months, and 1 year after infusion
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
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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