Using XKDCT080 cells to treat GCC-positive recurrent or refractory solid tumors

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

This study is testing a new treatment using XKDCT080 cells to see if it can help people with certain hard-to-treat solid tumors that have a specific marker called GCC.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Qingdao University (Academic / other)
• Drugs / interventions: Tozumab, Cyclophosphamide, Fludarabine, chimeric antigen receptor
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT05875402 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and tolerability of XKDCT080, a chimeric antigen receptor T cell preparation targeting guanylate cyclase (GCC), in patients with recurrent or refractory solid tumors that express GCC. The study will enroll 9-18 patients and will follow a single-arm, dose escalation design to assess the pharmacokinetics and preliminary effectiveness of the treatment. Participants will undergo a series of evaluations including screening, treatment, and long-term follow-up to monitor safety and therapeutic outcomes. The trial will also explore the relationship between cytokine levels and treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with GCC-positive solid tumors that have not responded to standard treatments.

Not a fit: Patients with solid tumors that do not express GCC or those who have not failed standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.

How similar studies have performed: While this approach is novel in targeting GCC-positive tumors, similar chimeric antigen receptor therapies have shown promise in other cancer types.

Eligibility criteria

Inclusion Criteria:

* To be eligible for the study, patients must meet ALL of the following criteria prior to participation:

  1. Age range from 18 to 75 years (including threshold), regardless of gender；
  2. Solid tumors with positive expression of guanylate cyclase (GCC) were detected by immunohistochemistry in tumor tissue；
  3. Patients with solid tumors who have failed standard treatment, are intolerant to standard treatment, have no standard treatment options, or have relapsed；
  4. 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；
  5. ECOG physical condition score 0-2；
  6. Blood routine standard: hemoglobin ≥ 90g/L (no blood transfusion within 14 days), neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L；
  7. 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;
  8. Cardiac ejection fraction\>50%；
  9. No hemorrhagic diseases or coagulation disorders；
  10. The expected survival period is ≥ 12 weeks；
  11. The subjects voluntarily participated in the study and signed an informed consent form.

Exclusion Criteria:

* Patients with any of the following criteria will not be allowed to participation:

  1. Pregnant or lactating women;
  2. Participate in other drug clinical trials within 4 weeks before screening;
  3. There are uncontrollable cardiovascular and cerebrovascular diseases within the first 6 months of screening, such as heart failure or others;
  4. Have a history of drug abuse and are unable to quit or have a history of mental disorders;
  5. Has received any immune cell therapy in the past;
  6. Fungi, bacteria, viruses, or other infections that cannot be controlled or require antibiotic treatment;
  7. 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;
  8. Allergies or intolerance to research drugs such as Tozumab, Fludarabine, Cyclophosphamide, Capecitabine, and other gonorrhea clearing drugs selected by the researchers;
  9. Active autoimmune diseases such as systemic lupus erythematosus or others within the first 3 months of screening;
  10. Suffering from known symptomatic central nervous system (CNS) diseases;
  11. The surgery was performed within 2 weeks before the single collection and the researcher believes that it may affect the safety of patient safety;
  12. There was a history of deep vein thrombosis or pulmonary embolism 6 months before enrollment;
  13. Used drugs that affect immune function one month before screening;
  14. Previously received GCC targeted therapy;
  15. According to the judgment of the researcher, patients who are not suitable to participate in this study;

Where this trial is running

Qingdao, Shandong

• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)

Study contacts

• Principal investigator: jing wang, MD — The Affiliated Hospital of Qingdao University
• Study coordinator: jing wang, MD

Conditions Colon Cancer; Chimeric Antigen