Actively Recruiting
Tolerance, Safety, and Preliminary Efficacy of KSX01-TCRT Injection in Adults with Refractory or Relapsed Solid Tumors
Led by TCRx Therapeutics Co.Ltd · Updated on 2023-04-13
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and early effects of KSX01-TCRT injection, a personalized TCR-T cell therapy, in adults aged 18 to 70 with refractory or relapsed solid tumors. The study aims to assess how well the treatment works against tumors and how the TCR-T cells activate and multiply in the body. This early phase 1 trial focuses on patients whose tumors have not responded to other treatments or for whom no standard treatments exist. Participants will receive individualized KSX01-TCRT cell injections designed from their own immune cells. The treatment involves collecting peripheral blood mononuclear cells to prepare autologous TCR-T cells, which are then infused back into the patient. The study monitors the treatment's safety and tumor response over approximately two years, with no placebo or comparison group. During the trial, participants undergo regular health assessments, including blood tests to check organ function and tumor evaluations following RECIST 1.1 criteria. Researchers will follow safety outcomes and tumor effectiveness for about two years after treatment. Study visits include monitoring physical fitness, survival status, and any adverse effects related to the therapy, with ongoing medical support throughout the participation period.
CONDITIONS
Brief Title
KSX01-TCRT Injection Project in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with full understanding and signed informed consent
- Age between 18 and 70 years old
- Diagnosed with malignant solid tumors unresponsive to standard treatment or without standard treatment options
- Presence of tumor lesions suitable for biopsy and screening for TCR sequence
- Recovery from previous treatment side effects to acceptable levels
- Adequate organ function as defined by specific blood, liver, kidney, and coagulation criteria
- ECOG physical fitness score of 0 or 1
- Expected survival of at least 12 weeks
- At least one evaluable or measurable tumor lesion
- Ability to provide sufficient blood cells for TCR-T cell preparation and intravenous infusion
- Negative pregnancy test for women of childbearing potential and use of approved contraception
- Male participants agree to use approved contraception and not to donate sperm during specified timeframes
You will not qualify if you...
- History of severe allergies or hypersensitivity to study drugs or components
- Prior treatment with other cell or gene therapy products
- Significant bleeding disorders or high bleeding risk conditions
- Unhealed wounds, ulcers, or fractures within 28 days before enrollment
- Recent live or attenuated vaccine use or planned use during the study
- Recent chemotherapy, targeted therapy, major surgery, or systemic steroid/immunomodulator use within specified periods
- Systemic bone metastases or leptomeningeal cancer history
- Brain metastases or spinal cord compression unless stable and asymptomatic
- Primary immune deficiency or active autoimmune diseases with risk of recurrence
- Active liver or biliary disease except certain stable conditions
- Recent serious cardiovascular events or uncontrolled fluid accumulations
- Certain cardiac conditions, severe diabetes, uncontrolled hypertension, or lung fibrosis
- Active severe infections or positive tests for HIV, syphilis, hepatitis B or C
- Expectation of needing other anti-tumor treatments during the study
- History of organ transplantation
- Pregnancy or lactation
- History of substance abuse or significant neurological or mental disorders
- Other conditions deemed inappropriate by the researcher for participation
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 - Up to about 2 years
Participants receive KSX01-TCRT injections as part of their treatment for refractory or relapsed solid tumors.
Visit schedule depends on treatment cycles and monitoring requirements
Duration - Up to about 2 years
Participants are monitored for safety and tumor response after treatment ends.
Periodic visits to assess safety and efficacy
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of Guang Xi medical university
Nanning, Guangxi, China, 530000
Actively Recruiting
Research Team
C
clinical trials ksh
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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