Advanced Solid TumorsPhase 1NCT07826585
Treatment of Patients With Advanced Solid Tumors Using CRTKVA11-03 TCR-T Cell Injection
A Phase 1 study testing CRTKVA11-03 TCR-T Cell Injection in people with Advanced Solid Tumors, 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
- Advanced Solid Tumors
- What is being tested?
- CRTKVA11-03 TCR-T Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2026to 31 Dec 2029
- 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
- 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
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality
About this study
Official title: An Exploratory Study on the Safety and Efficacy of CRTKVA11-03 TCR-T Cell Injection in Patients With 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
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- CRTKVA11-03 TCR-T Cell Injection
- Keywords
- KRAS G12V, Immunotherapy, T cell, Adoptive cell therapy, T cell receptor, TCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRTKVA11-03 TCR-T Cell InjectionDrug
Drug1 : Fludarabine + Cyclophosphamide Drug2 :Interleukin 2 Drug3 :CRTKVA11-03 TCR-T Cell Injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: CRTKVA11-03 TCR-T Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT (Dose Limiting Toxicity) Incidence Rate
Measured: 28 days
Explore the MTD (Maximum Tolerated Dose) or Subsequent Expansion Dose
Measured: 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.
Measured: 2 years
Secondary outcomes (6)
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
qPCR Monitoring of TCR-T Cell Copy Numbers in Peripheral Blood
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 posted17 Sep 2026
- Study start26 Mar 2026
- Primary completion30 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 6 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
- NCT07826585
- Sponsor's protocol ID
- CRTKVA11-2504C
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 17 Sep 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Safety and Efficacy of CRTKVA11-03 TCR-T Cell Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07826585
- Acronym / sponsor ID
- CRTKVA11-2504C
- Conditions
- Advanced Solid Tumors
- 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
- 6 participants (actual)
- Lead sponsor
- Corregene Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Sep 2026 (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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRTKVA11-03 TCR-T Cell Injection | Experimental | Drug: CRTKVA11-03 TCR-T Cell InjectionCRTKVA11-03 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 |
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)
- 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 |
|---|---|---|
| CRTKVA11-03 TCR-T Cell InjectionDrug1 : Fludarabine + Cyclophosphamide Drug2 :Interleukin 2 Drug3 :CRTKVA11-03 TCR-T Cell Injection | Drug | CRTKVA11-03 TCR-T Cell Injection |
Primary outcome
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
6 secondary outcomes
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)
Time frame: 2 years
qPCR Monitoring of TCR-T Cell Copy Numbers in Peripheral Blood
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 17 Sep 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 CRTKVA11-03 TCR-T Cell Injection in people with Advanced Solid Tumors, 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 17 Sep 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?
DLT (Dose Limiting Toxicity) Incidence Rate (time frame: 28 days). The study lists 3 primary outcomes in all. 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 17 Sep 2026.