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New treatment option for Refractory Solid Tumors
Official title Personalized KSX01-TCRT in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06150365
What this study is testing
What is KSX01-TCRT cell therapy?
KSX01-TCRT cell therapy is an investigational medicine, being studied as a potential treatment for refractory solid tumors.
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 trial is a single arm, open phase I clinical study to investigate the safety and efficacy of personalized KSX01-TCRT in patients with advanced solid tumors. This experiment is divided into two parts: the dose increasing stage (Part A) and the dose expanding stage (Part B).
- Phase 1: an early, usually small safety study
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
- Screening period 1- Patients should complete all examinations for screening period 1 within 28 days after signing the informed consent form. Only...
- Volunteer to participate in clinical research; Fully understand this study and voluntarily sign an informed consent form; Willing to follow and...
- Age range from 18 to 70 years old (including boundary values).
- Solid tumors that have been confirmed by histological or cytological evaluation as incurable or metastatic, and have failed standard treatment or...
- Expected survival time\>6 months.
You likely can't join if
- Screening period 1- Exclusion criteria: people who meet any of the following criteria shall not participate in this clinical study:
- The patient has received systemic chemotherapy on line 3 or above: Patients can be enrolled during the first line systemic chemotherapy, during the...
- The second and third line systemic chemotherapy is defined as a systematic chemotherapy regimen after the progression of frontline treatment;
- For patients who complete neoadjuvant chemotherapy in the early stage of their disease, their neoadjuvant chemotherapy regimen can include up to two...
- For patients who meet all other inclusion criteria but have a large number of frontline treatment lines, they can also be included after evaluation...
- Within two years before signing the informed consent, the patient had a medical history of other malignant tumors, except for non melanoma skin...
See the full eligibility criteria
Who can join
- Screening period 1- Patients should complete all examinations for screening period 1 within 28 days after signing the informed consent form. Only those who meet the for this stage can collect fresh tumor tissue, 2-3...
- Volunteer to participate in clinical research; Fully understand this study and voluntarily sign an informed consent form; Willing to follow and capable of completing all testing procedures.
- Age range from 18 to 70 years old (including boundary values).
- Solid tumors that have been confirmed by histological or cytological evaluation as incurable or metastatic, and have failed standard treatment or currently have no available standard treatment.
- Expected survival time\>6 months.
- ECOG score 0 or 1.
- Having sufficient organ function, defined as follows: 6.1) Hematology: 6.1.1) Hemoglobin 90 g/L (no blood transfusion received within 14 days prior to examination); 6.1.2) Absolute value of neutrophils 1.5 109/L (did...
- The patient's HLA-I class molecule IHC expression is positive.
- Patients with tumor lesions that can be collected and can screen out TCR sequences that can be used as drugs can enter the study. If the patient has obtained personalized TCR sequences using previously collected and...
- The patient agrees to receive peripheral monocyte collection after all tests in screening period 1 meet the standards.
- Screening period 2- After receiving confirmation notification of TCR sequence locking from the partner, or if the patient has obtained their personalized TCR sequence in other studies, they can be arranged to undergo...
- Expected survival time\>6 months.
- ECOG score 0 or 1.
- Having sufficient organ function, defined as follows: 4.1) Hematology: 4.1.1) Hemoglobin 90 g/L (no blood transfusion received within 14 days prior to examination); 4.1.2) Absolute value of neutrophils is 1.0 109/L (did...
- During the dose increasing stage, people only have evaluable lesions but can evaluate their how well it works through their serum tumor markers;
- The people currently do not have measurable lesions, but the researchers have determined that they may develop or become measurable lesions within one month. 9) The toxicity and adverse reactions caused by frontline...
What rules you out
- Screening period 1- Exclusion criteria: people who meet any of the following criteria shall not participate in this clinical study:
- The patient has received systemic chemotherapy on line 3 or above: Patients can be enrolled during the first line systemic chemotherapy, during the second line systemic chemotherapy period, or after the end of the...
- The second and third line systemic chemotherapy is defined as a systematic chemotherapy regimen after the progression of frontline treatment;
- For patients who complete neoadjuvant chemotherapy in the early stage of their disease, their neoadjuvant chemotherapy regimen can include up to two types of chemotherapy;
- For patients who meet all other inclusion criteria but have a large number of frontline treatment lines, they can also be included after evaluation and confirmation by the researchers. Frontline treatment plans...
- Within two years before signing the informed consent, the patient had a medical history of other malignant tumors, except for non melanoma skin cancer, some cancers in situ (such as cervical cancer, bladder cancer...
- Clinically confirmed liver diseases, including active hepatitis virus infection, alcoholic hepatitis, other types of hepatitis, cirrhosis, and hereditary liver diseases; Among them, the subject's
- Hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) are positive, and the hepatitis B virus DNA (HBV DNA) in the peripheral blood is higher than the lower detection limit of the research center;
- HCV-Ab positive and HCV-RNA above the lower detection limit of the research center Patients who can effectively control HBV-DNA and/or HCV-RNA after treatment can also be included in the group after being evaluated and...
- History of myocardial infarction, history of cardiac bypass surgery, unstable angina, active atrial fibrillation requiring treatment, symptomatic sinus bradycardia (heart rate\<50 beats/min), or other clinically...
- Tumor lesions invading the heart or large blood vessels. The patient has permanent percutaneous nephrostomy, catheterization, bile duct, and other indwelling tubes, except for those that the researchers believe can be...
- Screening Period 2- Exclusion Criteria people who meet any of the following criteria shall not undergo peripheral monocyte collection:
- Before monotherapy, the subject's anti-tumor treatment was not fully eluted (2 weeks or 5 half-lives, whichever is shorter): -Except for the following situations: Gonadotropin (GnRH) agonists or antagonists used for the...
- Known primary central nervous system (CNS) malignant tumors or symptomatic CNS metastases. If the patient is diagnosed with a central nervous system disease and meets the following conditions with the consent of the...
- There are measurable or evaluable lesions outside the CNS;
- No history of intracranial or spinal cord bleeding;
- There is no need for ongoing or planned corticosteroid treatment within 14 days prior to enrollment;
- Receiving stable doses of anticonvulsants;
- No stereotactic radiation or whole brain radiation therapy was received within 14 days prior to enrollment.
- Women during pregnancy or lactation.
- Receiving or planning to receive systemic corticosteroid therapy (\>5 mg of prednisone or equivalent treatment medication per day) or immunosuppressive drugs within 7 days prior to monotherapy, except for the following:
- Intranasal, inhalation, topical steroids, or local administration (such as intra articular injection);
- Physiological doses of systemic steroids as an alternative therapy (such as physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction);
- Steroids are used as prophylactic drugs for hypersensitivity reactions (such as computed tomography [CT] prophylactic drugs).
- The first second forced expiratory volume (FEV1)/forced vital capacity (FVC)\<70% during lung function examination indicates abnormal lung function.
- According to the judgment of the researchers, the underlying condition of the people may increase their risk of receiving investigational drug treatment, or may cause confusion in the interpretation of toxic reactions...
- There are severe infections within 2 weeks before single collection. Major surgery (excluding diagnostic surgery) is performed within 4 weeks prior to single collection, or is expected to be performed during the study...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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, 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.