ColorectalPhase 1NCT06767046
KRAS-Specific Autologous TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors
A Phase 1 study testing KRAS-specific Autologous TCR-T cell injection in people with Colorectal and Pancreatic, run by Corregene Biotechnology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal, Pancreatic, Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- KRAS-specific Autologous TCR-T cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2025to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1.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
Show all 24Show fewer
- 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.
- Left ventricular ejection fraction (LVEF) < 50%.
- Symptomatic brain metastases unless stabilized with prior treatment (e.g., surgery or radiotherapy).
- Known history of myelodysplastic syndrome, lymphoma, or other malignancies.
- Known allergy to albumin, investigational drugs, or their excipients.
- Active autoimmune diseases, including but not limited to acquired/congenital immunodeficiency, organ transplantation, autoimmune hepatitis, systemic lupus erythematosus, or inflammatory bowel disease.
- Active hepatitis B, hepatitis C, or HIV infection.
- Pregnancy or breastfeeding.
- Uncontrolled mental or neurological disorders.
- Any condition deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University Affiliated Beijing Ditan Hospital
Beijing, Beijing Municipality
About this study
Official title: An Exploratory Study to Evaluate the Safety and Preliminary Efficacy of KRAS-Specific Autologous TCR-T Cells in Advanced Solid Tumors
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.
Read the detailed description
T cell receptor-gene engineered T cells (TCR-T) therapy is a highly targeted form of cellular immunotherapy. It is safer than Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) and is currently a hot topic in immunotherapy. In the case of advanced pancreatic cancer with KRAS mutations, the infusion of TCR-T cells has achieved good efficacy and safety, further suggesting the promising prospects of TCR-T cell immunotherapy for advanced solid tumors with KRAS G12V mutation.
It is planned to enroll 9 - 18 patients with advanced solid tumors who have KRAS G12V mutation and HLA-A*11:01 genotype, and have failed standard treatments. A single-center, open-label, single-arm study design will be adopted. The KRAS-specific autologous TCR-T cell injection will be used to treat these patients. The primary endpoint is safety, and the secondary endpoints include efficacy, cell activity, etc. It is planned to select three dose groups with 5×10⁹, 1×10¹⁰, and 2×10¹⁰ TCR-T cells respectively, and conduct dose escalation using a 3 + 3 study design.
The key steps involved in the study are the preparation and quality control of TCR-T cells, lymphocyte depletion (lymphodepletion), and the infusion of autologous TCR-T cell injection. Record and promptly handle specific adverse reactions of cellular immunotherapy, such as cytokine release syndrome (CRS), various other adverse events, off-target effects of TCR-T, and adverse events related to tumorigenic potential, etc., to obtain safety data. It is hoped that the results of this study will bring a new future for patients with advanced solid tumors with specific KRAS mutations.
- Conditions
- Colorectal, Pancreatic, Non-small Cell Lung Cancer (NSCLC)
- Being tested
- KRAS-specific Autologous TCR-T cell injection
- Keywords
- KRAS G12V, immunotherapy, T cell, Adoptive cell therapy, T cell receptor, TCR
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRAS-specific Autologous TCR-T cell injectionDrug
Also called CRTKVA11-N04
Drug1 : Fludarabine + Cyclophosphamide Drug2 :Interleukin 2 Drug3 :KRAS-specific Autologous TCR-T cell injection
| Study group | Role | What they receive |
|---|---|---|
| KRAS-specific Autologous TCR-T cell injection | Experimental | KRAS-specific Autologous 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 Receives: Drug: KRAS-specific Autologous TCR-T cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs)
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs)
Measured: 2 years
Secondary outcomes (5)
Objective Response Rate (ORR)
Assessed by RECIST 1.1
Measured: 2 years
Disease Control Rate (DCR)
Assessed by RECIST 1.1
Measured: 2 years
Duration of Response (DOR)
Assessed by RECIST 1.1
Measured: 2 years
Progression-Free Survival (PFS)
Assessed by RECIST 1.1
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start18 Feb 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColorectalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corregene Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767046
- Sponsor's protocol ID
- CRTKVA11-2311C
- Status last verified
- Mar 2026
- First submitted
- 5 Jan 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Safety and Preliminary Efficacy of KRAS-Specific Autologous TCR-T Cells in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06767046
- Acronym / sponsor ID
- CRTKVA11-2311C
- Conditions
- Colorectal, Pancreatic, Non-small Cell Lung Cancer (NSCLC)
- Keywords
- KRAS G12V, immunotherapy, T cell, Adoptive cell therapy, T cell receptor, TCR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Corregene Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
T cell receptor-gene engineered T cells (TCR-T) therapy is a highly targeted form of cellular immunotherapy. It is safer than Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) and is currently a hot topic in immunotherapy. In the case of advanced pancreatic cancer with KRAS mutations, the infusion of TCR-T cells has achieved good efficacy and safety, further suggesting the promising prospects of TCR-T cell immunotherapy for advanced solid tumors with KRAS G12V mutation.
It is planned to enroll 9 - 18 patients with advanced solid tumors who have KRAS G12V mutation and HLA-A*11:01 genotype, and have failed standard treatments. A single-center, open-label, single-arm study design will be adopted. The KRAS-specific autologous TCR-T cell injection will be used to treat these patients. The primary endpoint is safety, and the secondary endpoints include efficacy, cell activity, etc. It is planned to select three dose groups with 5×10⁹, 1×10¹⁰, and 2×10¹⁰ TCR-T cells respectively, and conduct dose escalation using a 3 + 3 study design.
The key steps involved in the study are the preparation and quality control of TCR-T cells, lymphocyte depletion (lymphodepletion), and the infusion of autologous TCR-T cell injection. Record and promptly handle specific adverse reactions of cellular immunotherapy, such as cytokine release syndrome (CRS), various other adverse events, off-target effects of TCR-T, and adverse events related to tumorigenic potential, etc., to obtain safety data. It is hoped that the results of this study will bring a new future for patients with advanced solid tumors with specific KRAS mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KRAS-specific Autologous TCR-T cell injection | Experimental | Drug: KRAS-specific Autologous TCR-T cell injectionKRAS-specific Autologous 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (24 listed)
- 1.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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KRAS-specific Autologous TCR-T cell injectionAlso: CRTKVA11-N04Drug1 : Fludarabine + Cyclophosphamide Drug2 :Interleukin 2 Drug3 :KRAS-specific Autologous TCR-T cell injection | Drug | KRAS-specific Autologous TCR-T cell injection |
Primary outcome
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs)
Time frame: 2 years
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs)
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Duration of Response (DOR)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KRAS-specific Autologous TCR-T cell injection in people with Colorectal and Pancreatic, run by Corregene Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.