Custom-Built immune cells take aim at a notorious cancer mutation
NCT ID NCT07826585
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing a new cell therapy called CRTKVA11-03 in people with advanced solid tumors that carry a specific KRAS G12V mutation and a matching immune marker called HLA-A*11:01. The treatment uses each patient's own T cells, engineered to recognize and attack cancer cells with that mutation. The small Phase 1 study gives the cells after short courses of chemotherapy and interleukin-2, and its main goals are to find a safe dose and watch for early signs that tumors respond.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CRTKVA11-03 TCR-T cell injection, engineered immune cells that target the KRAS G12V mutation
- What this could lead to
- If it works, this could point toward a cell therapy for advanced solid tumors that carry the KRAS G12V mutation, including colorectal, pancreatic, and lung cancers.
- What could go wrong
- This is a first-in-human Phase 1 study with only 6 participants, so it mainly tests safety and dosing. The therapy may not shrink tumors, may cause serious immune reactions, and any benefit seen in a few people may not apply more widely.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Mar 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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