IX001 TCR-T In the Treatment of Advanced Pancreatic Cancer and Colorectal Cancer Induced by KRAS Mutations
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Pudong Hospital
About this trial
This is a single-arm, single-center, open-label clinical study aimed at evaluating the safety and efficacy of IX001 TCR-T (T cell receptor-engineered T-Cell) injection in patients with advanced pancreatic cancer and colorectal cancer induced by KRAS (Kirsten Rat Sarcoma Viral Oncogene) mutations. A total of 6-18 evaluable patients are planned to be enrolled. The study will include 4 dose groups, using a '3+3' dose escalation design.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary signing of an informed consent form (ICF);
Males or females, aged 18-70 years (inclusive);
Pathologically diagnosed with advanced pancreatic cancer or colorectal cancer, having failed or intolerant to at least two lines of standard of care, including metastatic tumors (having received conventional chemotherapy), recurrent tumors (having undergone surgery and adjuvant chemotherapy in the past), or locally advanced tumors with disease progression after neoadjuvant treatment;
At least one measurable lesion (according to RECIST1.1[The Response Evaluation Criteria In Solid Tumors] criteria);
Disqualifiers
Other malignancies (except non-melanoma skin cancer with the disease-free survival of more than 5 years and cervical carcinoma in situ, bladder cancer, or breast cancer);
A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the ICF;
Poorly controlled hypertension with drug (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg) or occurrence of grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stent placement, unstable angina pectoris, or other clinically significant heart diseases within one year prior to signing the ICF; QTc interval >450 ms for males or QTc interval >470 ms for females during screening (QTc interval calculated using the Fridericia formula);
Presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy tube, indwelling catheter, bile drainage tube or pleural/peritoneal/pericardial catheter), except any dedicated central venous catheter;
Trial design
Design model
Single group
Treatments tested in this trial
IX001 TCR-T cells
Biological/VaccineIX001 TCR-T cell injection will be administered intravenously after lymphodepletion.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: IX001 TCR-T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting Toxicity (DLT)
Proportion of patients with DLT
Time frame
4 weeks2
Adverse Events (AEs)
Incidence and severity of adverse events
Time frame
96 weeks3
Serious Adverse Events (SAEs)
Incidence and severity of serious adverse events
Time frame
96 weeksSecondary outcomes
1
Objective Response Rate (ORR)
The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1
Time frame
12 weeks2
Disease Control Rate (DCR)
The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1
Time frame
12 weeks3
Changes in Serum Tumor Markers compared to Baseline
Changes of tumor markers in serum detected by immunofluorescence compared to baseline level, including carbohydrate antigen 19-9 (CA19-9), carcinoembryonic antigen (CEA), and carbohydrate antigen 12-5 (CA12-5)
Time frame
12 weeks4
Duration of response (DOR)
DOR is defined as the time from the first evaluation of a tumor as CR or PR to the first evaluation as PD or death from any cause
Time frame
96 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Pudong Hospital
Lead sponsor
ImmuXell Biotech Ltd.
Collaborator
Source ClinicalTrials.gov