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New treatment option for Safety Issues
Official title NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors
ClinicalTrials.gov ID: NCT06509490
What this study is testing
What is KD-025 cell injection?
KD-025 cell injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for safety issues.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients diagnosed as advanced solid tumors histopathologically or cytologically, such as ovarian, cholangiocarcinoma, and colorectal cancer.
- Patients fail standard treatment , or cannot tolerate standard treatment, or there is no standard treatment, the standard treatment recommendations...
- Age 18-70 years;
- ECOG score 0-1;
- Expected survival ≥ 3 months;
You likely can't join if
- Patients had received any gene therapy (including CAR-T cell therapy) or any T cell therapy, Active bacteria or viral or fungal infection and not...
- Patients have an autoimmune disease or organ transplant, require chronic systemic steroid therapy or any other form of immunosuppressive drugs;
- A history of serious heart or lung disease, including uncontrolled hypertension medication, and any condition that occurred within the past 6 months...
- Detected clinically relevant central nervous system (CNS) metastases and/or pathologies, such as seizures, cerebral ischemia/bleeding, dementia...
- The Patients' history or existing evidence of any condition such as neuroticism, psychosis, immunology, metabolism, and infectious disease, in any...
- The Patients have a history of hematologic malignancy or concurrent history of other malignant primary solid tumors, except for: 1) Patients with...
See the full eligibility criteria
- Patients diagnosed as advanced solid tumors histopathologically or cytologically, such as ovarian, cholangiocarcinoma, and colorectal cancer.
- Patients fail standard treatment , or cannot tolerate standard treatment, or there is no standard treatment, the standard treatment recommendations refer to the latest version of the guidelines of the national...
- Age 18-70 years;
- ECOG score 0-1;
- Expected survival ≥ 3 months;
- Patients must meet coagulation parameters and have adequate peripheral venous access for apheresis, and must also have enough PBMC to manufacture CAR T cells;
- NKG2DL (according to the positive comprehensive score of 0-12 points, positive SCORE of NKG2DL ≥2) positive confirmed byImmunohistochemistry. Biopsy tissue must be no more than 1 year, if not, must obtain new tissue...
- Eligible organ and bone marrow functions defined as follows:1) Absolute neutrophil count ≥1.5×10\^9/L, lymphocyte count ≥0.5×10\^9/ L, platelet count ≥90×10\^9/L, hemoglobin ≥90g/L (no blood transfusion or...
- Patients must have measurable lesions as defined by RECIST 1.1;
- Patients fully understand the test and voluntarily sign the informed consent;
- Patient agree to use approved contraceptive methods (e.g., birth control pills, barrier devices, iuds, contraindicated drugs) during the study and for at least 12 months after last cell infusion, until no CAR-T cells...
- Patients had received any gene therapy (including CAR-T cell therapy) or any T cell therapy, Active bacteria or viral or fungal infection and not controlled after anti-infective treatment (positive blood test 72 hours...
- Patients have an autoimmune disease or organ transplant, require chronic systemic steroid therapy or any other form of immunosuppressive drugs;
- A history of serious heart or lung disease, including uncontrolled hypertension medication, and any condition that occurred within the past 6 months: congestive heart failure (New York Heart Association functional...
- Detected clinically relevant central nervous system (CNS) metastases and/or pathologies, such as seizures, cerebral ischemia/bleeding, dementia, cerebellar diseases or autoimmune diseases affecting the CNS;
- The Patients' history or existing evidence of any condition such as neuroticism, psychosis, immunology, metabolism, and infectious disease, in any treatment, or laboratory abnormalities may confuse the outcome of the...
- The Patients have a history of hematologic malignancy or concurrent history of other malignant primary solid tumors, except for: 1) Patients with cervical or breast cancer in situ who have no evidence of disease for...
- Received chemotherapy, radiation, small molecule, biologic cancer therapy, immunotherapy, or other experimental drugs within 4 weeks prior to study initiation,
- Pregnant or lactating women;
- The investigator considers the Patients have or with current historical evidence of any condition, therapy, or laboratory anomaly that may confound the results of the study, interfere with the Patients' participation in...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.