This is a single-center, open-label, single-arm, dose-escalation study aimed at evaluating the safety and preliminary efficacy of KRAS-specific autologous TCR-T cells in patients with advanced solid tumors harboring KRAS G12V mutation.
CRTKVA11-03 injection was developed based on affinity-optimized KRAS G12V-specific TCR molecules. Its safety and tolerability was explored in a single-center, open-label, single-arm, dose-escalation study. 9 - 18 patients with advanced solid tumors who have KRAS G12V mutation and HLA-A\*11:01 genotype, and have failed standard treatments will be treated wtith CRTKVA11-03 TCR-T injection. The primary objective is to evaluate the safety and tolerability of CRTKVA11-03 in the treatment of advanced malignant solid tumors, the secondary objective is to describe the pharmacokinetic (PK) characteristics of CRTKVA11-03 after infusion into humans, observe their proliferation and persistence in vivo. The key study procedures include leucocyte apheresis and preparation of TCR-T cells, lymphocyte depletion (lymphodepletion), and the infusion of CRTKVA11-03 injection and follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Drug1 : Fludarabine + Cyclophosphamide Drug2 :Interleukin 2 Drug3 :CRTKVA11-03 TCR-T Cell Injection
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
DLT (Dose Limiting Toxicity) Incidence Rate
Time frame: 28 days
Explore the MTD (Maximum Tolerated Dose) or Subsequent Expansion Dose
Time frame: 28 days
Safety Assessment: Changes in patient safety parameters at various follow-up time points after TCR-T infusion, as well as the incidence of adverse events (AEs), which were graded according to the CTCAE V6.0 severity scale.
Time frame: 2 years
Objective Response Rate (ORR) Assessed by RECIST 1.1
Time frame: 2 years
Disease Control Rate (DCR) Assessed by RECIST 1.1
Time frame: 2 years
Duration of Response (DOR) Assessed by RECIST 1.1
Time frame: 2 years
Progression-Free Survival (PFS) Assessed by RECIST 1.1
Time frame: 2 years
Overall Survival (OS)
Overall survival was defined as the time from KRAS-Specific Autologous TCR-T Cell infusion to the date of death
Time frame: 2 years
qPCR Monitoring of TCR-T Cell Copy Numbers in Peripheral Blood
Time frame: 2 years
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