Treatment of Patients With Advanced Solid Tumors Using CRTKVA11-03 TCR-T Cell Injection

NCT07826585 | Active Not Recruiting Phase 1

• 1 other identifier: CRTKVA11-2504C
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumors

Keywords

KRAS G12V; Immunotherapy; T cell; Adoptive cell therapy; T cell receptor; TCR

Outcome Measures

Primary Outcomes (3)

• DLT (Dose Limiting Toxicity) Incidence Rate

  28 days

• Explore the MTD (Maximum Tolerated Dose) or Subsequent Expansion Dose

  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.

  2 years

Secondary Outcomes (6)

• Objective Response Rate (ORR) Assessed by RECIST 1.1

  2 years

• Disease Control Rate (DCR) Assessed by RECIST 1.1

  2 years

• Duration of Response (DOR) Assessed by RECIST 1.1

  2 years

• Progression-Free Survival (PFS) Assessed by RECIST 1.1

  2 years

• Overall Survival (OS)

  2 years

Study Arms (1)

CRTKVA11-03 TCR-T Cell Injection

EXPERIMENTAL

CRTKVA11-03 TCR-T Cell Injection (5×10⁹, 1×10¹°, or 2×10¹° TCR-T cells per dose) with preconditioning lymphodepletion using Fludarabine and Cyclophosphamide, followed by IL-2 support

Drug: CRTKVA11-03 TCR-T Cell Injection

Interventions

CRTKVA11-03 TCR-T Cell Injection DRUG

Drug1 : Fludarabine + Cyclophosphamide Drug2 :Interleukin 2 Drug3 :CRTKVA11-03 TCR-T Cell Injection

CRTKVA11-03 TCR-T Cell Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-70 years.
• Histologically or cytologically confirmed advanced solid tumors (e.g., colorectal cancer, pancreatic cancer, NSCLC) with KRAS G12V mutations and HLA-A\*11:01 genotype.
• Failed standard therapies or no effective treatment available.
• ECOG performance status of 0-1.
• Life expectancy of ≥3 months.
• Presence of at least one measurable lesion as defined by RECIST 1.1 criteria.
• Female patients of childbearing potential must agree to use highly effective contraceptive methods during the study and for at least 6 months after the last dose. A negative pregnancy test within 7 days prior to treatment initiation is required.
• Written informed consent provided by the patient, with an expectation of compliance with study procedures.

You may not qualify if:

• Prior treatment with gene-modified T-cell therapies.
• Current treatment with T-cell suppressive agents (e.g., cyclophosphamide, FK506, tripterygium glycosides) or T-cell stimulants.
• Chemotherapy, targeted therapy, immunotherapy, or investigational drugs administered within 2 weeks, or radiotherapy within 4 weeks prior to enrollment.
• Significant organ dysfunction, as evidenced by:
• leukocytes\<3.0 x 109/L
• absolute neutrophil count \>1.5 x 109/L
• hemoglobin\<90g/L
• platelets \<100 x 109/L
• Creatinine\>1.5×ULN or creatinine clearance \<50mL/min
• lymphocytes\<0.5 x 109/L
• total bilirubin\>3×ULN; ALT/AST\>3×ULN (or \>5× ULN in patients with liver metastases)
• INR/APTT\>1.5×ULN
• SpO2≤93%
• Presence of serious diseases and comorbidities, including but not limited to: severe heart disease, cerebrovascular disease, seizures, poorly controlled diabetes (such as Type 1 diabetes or insulin-dependent diabetes), pancreatic dysfunction, severe infections, active gastrointestinal ulcers, gastrointestinal bleeding, mechanical or paralytic bowel obstruction, pulmonary fibrosis, renal failure, respiratory failure, etc.
• History of severe cardiovascular diseases within the past 6 months, including but not limited to: myocardial infarction, severe or unstable angina, coronary artery or peripheral artery bypass surgery, New York Heart Association (NYHA) Class III or IV heart failure, etc.

Sponsors & Collaborators

• Corregene Biotechnology Co., Ltd: lead

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 17, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)