A Phase I Clinical Study of KXV01 TCR Lentinvivo Injection on Safety, Tolerability, and Efficacy in Patients With Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Dose-limiting Toxicity
Study Overview
Brief Summary
This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KXV01 TCR Lentinvivo for patients with advanced solid tumors.
Detailed Description
In recent years, the field has found that patient-specific anti-tumor treatment technologies have increasingly significant clinical application prospects and clinical value. Patient-specific anti-tumor in vivo TCR gene therapy is an advanced therapeutic strategy that can specifically recognize tumor neoantigens. This strategy is not restricted by patients' HLA typing nor by the type of indication.
This investigator-initiated clinical study aims to evaluate KXV01 TCR Lentinvivo, the third-generation self-inactivating lentiviral vector that carries patient-derived personalized tumor reactive TCR, in patients with advanced solid tumors. The study employs a BOIN design to assess safety, tolerability, and preliminary efficacy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
KXV01 TCR Lentinvivo Injection
KXV01 TCR Lentinvivo Injection
Intervention: KXV01 TCR Lentinvivo Injection (Drug)
Outcomes
Primary Outcomes
Dose-limiting Toxicity
Time Frame: 28 days after administraiton
DLT evaluation period: The DLT evaluation period is defined as within 28 days (inclusive) after the subjects' first infusion of KXV01 injection during the dose escalation stage. All adverse events should be graded and evaluated in accordance with CTCAE v5.0. Among them, cytokine release syndrome (CRS) and immune effector cell-related neurotoxicity syndrome (ICANS) should be determined and graded in accordance with the standards of the American Society for Transplantation and Cell Therapy (ASTCT).
Secondary Outcomes
No secondary outcomes reported