Colon CancerNCT05875402
XKDCT080 in GCC-positive Recurrent or Refractory Solid Tumors With Single Center, Single Arm, and Dose Escalation
A study testing Chimeric antigen receptor T cell preparation targeting GCC in people with Colon Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The goal of this clinical trial is to assessing the safety and tolerability of XKDCT080 cells against recurrent or refractory solid tumors with GCC positivity.This experiment proposes to enroll 9-18 patients, the experimental drug is a chimeric antigen receptor T cell preparation targeting GCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Chimeric antigen receptor T cell preparation targeting GCC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for the study, patients must meet ALL of the following criteria prior to participation:
- Age range from 18 to 75 years (including threshold), regardless of gender；
- Solid tumors with positive expression of guanylate cyclase (GCC) were detected by immunohistochemistry in tumor tissue；
- Patients with solid tumors who have failed standard treatment, are intolerant to standard treatment, have no standard treatment options, or have relapsed；
- At least one measurable lesion (non lymph node lesion with a length diameter of ≥ 10mm and lymph node lesion with a short diameter of ≥ 15mm) is required using the RECIST 1.1 standard；
- ECOG physical condition score 0-2；
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- Blood routine standard: hemoglobin ≥ 90g/L (no blood transfusion within 14 days), neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L；
- Blood biochemistry should meet the following standards: total bilirubin ≤ 1.5 × ULN (upper limit of normal value), ALT and AST ≤ 2.5 × ULN (excluding patients with liver metastasis); ALT and AST ≤ 5 in patients with liver metastasis × ULN； Serum creatinine ≤ 1 × ULN, glomerular filtration rate>50mL/min (GFR=[(140 age) × weight × (0.85 female)]/(72 × Scr), serum lipase and amylase<1.5 × ULN (upper limit of normal value), albumin ≥ 2.8g/dL;
- Cardiac ejection fraction>50%；
- No hemorrhagic diseases or coagulation disorders；
- The expected survival period is ≥ 12 weeks；
- The subjects voluntarily participated in the study and signed an informed consent form.
Who cannot join
- Patients with any of the following criteria will not be allowed to participation:
- Pregnant or lactating women;
- Participate in other drug clinical trials within 4 weeks before screening;
- There are uncontrollable cardiovascular and cerebrovascular diseases within the first 6 months of screening, such as heart failure or others;
- Have a history of drug abuse and are unable to quit or have a history of mental disorders;
- Has received any immune cell therapy in the past;
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- Fungi, bacteria, viruses, or other infections that cannot be controlled or require antibiotic treatment;
- Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, and HBV-DNA>500 IU/mL; Patients with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Syphilis antibody positive individuals;
- Allergies or intolerance to research drugs such as Tozumab, Fludarabine, Cyclophosphamide, Capecitabine, and other gonorrhea clearing drugs selected by the researchers;
- Active autoimmune diseases such as systemic lupus erythematosus or others within the first 3 months of screening;
- Suffering from known symptomatic central nervous system (CNS) diseases;
- The surgery was performed within 2 weeks before the single collection and the researcher believes that it may affect the safety of patient safety;
- There was a history of deep vein thrombosis or pulmonary embolism 6 months before enrollment;
- Used drugs that affect immune function one month before screening;
- Previously received GCC targeted therapy;
- According to the judgment of the researcher, patients who are not suitable to participate in this study;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
jing wang, 18661805686, wangstella5@163.com
About this study
Official title: Exploratory Clinical Trial on the Safety, Tolerability, Efficacy, and Pharmacokinetics of XKDCT080 in GCC-positive Recurrent or Refractory Solid Tumors With Single Center, Single Arm, and Dose Escalation
The goal of this clinical trial is to assessing the safety and tolerability of XKDCT080 cells against recurrent or refractory solid tumors with GCC positivity.This experiment proposes to enroll 9-18 patients, the experimental drug is a chimeric antigen receptor T cell preparation targeting GCC.
Secondary purpose of the study
- Evaluate the pharmacokinetic characteristics of XKDCT080 cells after intravenous infusion into GCC-positive patients with recurrent or refractory solid tumors;
- Preliminary Evaluation of the Effectiveness of XKDCT080 Cells in Patients with Recurrent or Refractory Solid Tumors Positive for GCC;
- Explore the relationship between cytokines and therapeutic efficacy in patients with recurrent or refractory solid tumors who are positive for GCC after intravenous infusion of XKDCT080 cells.
Read the detailed description
This study adopts a single arm, single center, and dose increasing design, using a "3+3" design for dose increasing to evaluate the safety, tolerance, and effectiveness of XKDCT080 cells, as well as to evaluate the pharmacokinetic characteristics of XKDCT080 cells, the correlation between cytokines and efficacy, and immunogenicity.
The experimental process of this study is divided into seven stages: screening period, blood collection period, baseline period, clearance period, study treatment and safety observation period after treatment, follow-up period, and long-term follow-up.
- Conditions
- Colon Cancer
- Being tested
- Chimeric antigen receptor T cell preparation targeting GCC
- Keywords
- Chimeric Antigen
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimeric antigen receptor T cell preparation targeting GCCDrug
Chimeric antigen receptor T cell preparation targeting GCC
| Study group | Role | What they receive |
|---|---|---|
| XKDCT080 treatment for patients with GCC target positivity | Experimental | Drug: XKDCT080 (chimeric antigen receptor T cell preparation targeting GCC)
Dosage form: Cell suspension
Dose: 30-50mL/bag
Medication method: intravenous drip
Frequency: Once Receives: Drug: Chimeric antigen receptor T cell preparation targeting GCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
To characterize the safety profile of XKDCT080 in patients with advanced solid tumor as assessed by incidence of adverse events
Measured: 12 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Apr 2023
- Primary completion28 Dec 2023 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wangjing, The Affiliated Hospital of Qingdao University
- Investigators
- jing wang, MD, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875402
- Sponsor's protocol ID
- XKDCT080
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Trial on the Safety, Tolerability, Efficacy, and Pharmacokinetics of XKDCT080 in GCC-positive Recurrent or Refractory Solid Tumors With Single Center, Single Arm, and Dose Escalation
- ClinicalTrials.gov ID
- NCT05875402
- Acronym / sponsor ID
- XKDCT080
- Conditions
- Colon Cancer
- Keywords
- Chimeric Antigen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 28 Dec 2023 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 25 May 2023 (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.
The goal of this clinical trial is to assessing the safety and tolerability of XKDCT080 cells against recurrent or refractory solid tumors with GCC positivity.This experiment proposes to enroll 9-18 patients, the experimental drug is a chimeric antigen receptor T cell preparation targeting GCC.
Secondary purpose of the study
- Evaluate the pharmacokinetic characteristics of XKDCT080 cells after intravenous infusion into GCC-positive patients with recurrent or refractory solid tumors;
- Preliminary Evaluation of the Effectiveness of XKDCT080 Cells in Patients with Recurrent or Refractory Solid Tumors Positive for GCC;
- Explore the relationship between cytokines and therapeutic efficacy in patients with recurrent or refractory solid tumors who are positive for GCC after intravenous infusion of XKDCT080 cells.
Detailed description
This study adopts a single arm, single center, and dose increasing design, using a "3+3" design for dose increasing to evaluate the safety, tolerance, and effectiveness of XKDCT080 cells, as well as to evaluate the pharmacokinetic characteristics of XKDCT080 cells, the correlation between cytokines and efficacy, and immunogenicity.
The experimental process of this study is divided into seven stages: screening period, blood collection period, baseline period, clearance period, study treatment and safety observation period after treatment, follow-up period, and long-term 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 |
|---|---|---|
| XKDCT080 treatment for patients with GCC target positivity | Experimental | Drug: Chimeric antigen receptor T cell preparation targeting GCCDrug: XKDCT080 (chimeric antigen receptor T cell preparation targeting GCC) Dosage form: Cell suspension Dose: 30-50mL/bag Medication method: intravenous drip Frequency: Once |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- To be eligible for the study, patients must meet ALL of the following criteria prior to participation:
Key exclusion criteria (16 listed)
- Patients with any of the following criteria will not be allowed to participation:
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 |
|---|---|---|
| Chimeric antigen receptor T cell preparation targeting GCCChimeric antigen receptor T cell preparation targeting GCC | Drug | XKDCT080 treatment for patients with GCC target positivity |
Primary outcome
Adverse Events (AE)
Time frame: 12 months]
To characterize the safety profile of XKDCT080 in patients with advanced solid tumor as assessed by incidence of adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- 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.
jing wang, MD principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chimeric antigen receptor T cell preparation targeting GCC in people with Colon Cancer, run by The Affiliated Hospital of Qingdao University 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 12 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 25 May 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jing wang, MD (18661805686, wangstella5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) (time frame: 12 months]). 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 May 2023.