Infusing iNKT and PD-1+ CD8+ T cells for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 interventional trial gives patients laboratory‑expanded invariant natural killer T (iNKT) cells together with PD‑1+ CD8+ T cells that are likely tumor‑specific. The two cell types are expanded ex vivo from patient samples using the investigators' published/patented methods and then infused back into participants, with close monitoring for safety, immune response, and tumor change. Eligible patients have advanced solid tumors (including lung, pancreas, liver, stomach, and colorectal cancers) and undergo regular laboratory testing and imaging during follow‑up. Primary endpoints focus on safety and tolerability, with secondary measures including changes in tumor burden and overall survival.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological or cytologically diagnosis of advanced lung cancer, or advanced gastric cancer, or advanced pancrease cancer, or hepatocellular carcinoma, or advanced colorectal cancer
* Patients' tumor tissue (formalin-fixed, paraffin-embedded) must be sufficient for diagnosis of cancer by a certified Laboratory of Pathology
* Laboratory values within the following ranges prior to receiving treatment of study agent: Hemoglobin≧8.0 g/dL, Neutrophils count≧1E9/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧50E9/L, Serum creatinine≦2.0 mg/dL, Serum bilirubin≦2 x upper limit of institutional normal, AST/ALT≦2 x upper limit of institutional normal
* No dyspnea at rest. Oxygen saturation ≥90% on room air
* No genetic disease
* Fertile females/males must consent to use contraceptives during participation of the trial. Women of child bearing potential must have a negative pregnancy test prior to receiving treatment of study agent within 7 days
* Patients must have a Karnofsky performance status greater than or equal to 80%
* Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure
* Agrees to participate in long-term follow-up for up to 1 years, if received NKT infusion

Exclusion Criteria:

* Organ dysfunction,such as significant cardiovascular disease, myocardial infarction within the past six months, unstable angina, coronary angioplasty within the past six months, uncontrolled atrial or ventricular cardiac arrhythmias; Child-Pugh C; Renal function failure or uremia; Respiratory failure; Disturbance of consciousness; Renal failure.
* Suffering from lymphoma or leukemia
* Serious infections requiring antibiotics, bleeding disorders
* Patients with myelodysplastic syndrome (MDS)
* History of immunodeficiency disease or autoimmune disease
* Positive HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
* Within concurrent chemotherapy
* Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy
* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent
* Pregnant or breast-feeding patients
* Can't give informed consent
* Lack of availability for follow-up assessment

Where it's running

• Shanghai Public Health Clinical Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Yan X Zhang, M.D.
• Email: zhangxiaoyan@shaphc.org
• Phone: 0086-021-37990333

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing MGC026 in patients with advanced solid tumors

  This study is testing a new treatment called MGC026 to see if it can help adults with advanced solid tumors that can't be removed or have spread to other parts of the body.

  Recruiting at 12 sites Phase 1 MacroGenics · Los Angeles, California and 11 other locations · NCT06242470

• First-in-human test of HH160 in people with advanced solid tumors

  HH160 is being tested to see if it is safe and how it behaves in the body, to see if it has early signs of helping various advanced cancers in adults.

  Recruiting at 3 sites Phase 1 Huahui Health · Waratah, New South Wales and 2 other locations · NCT07623369

• Testing NEO212 for treating certain brain tumors and metastases

  This study is testing a new treatment called NEO212 for people with certain types of brain tumors to see if it is safe and effective when combined with standard treatments.

  Recruiting at 8 sites Phase 1/2 Neonc Technologies, Inc. · Beverly Hills, California and 7 other locations · NCT06047379

• Subcutaneous versus intravenous immune therapy: which do patients prefer?

  This project will test whether patients with advanced cancers prefer subcutaneous (under‑the‑skin) versus intravenous nivolumab or, if available, pembrolizumab.

  Recruiting Phase 2 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07223424

• IDOV-Immune for advanced solid tumors

  This trial will try a single IV infusion of an engineered oncolytic vaccinia virus called IDOV-Immune in adults with advanced solid tumors that no longer respond to standard treatments.

  Recruiting at 5 sites Phase 1 ViroMissile, Inc. · St Louis, Missouri and 4 other locations · NCT06910657

• Investigating QXL138AM for patients with advanced solid tumors and multiple myeloma

  This study is testing a new drug called QXL138AM to see if it can safely help people with advanced solid tumors and multiple myeloma.

  Recruiting at 11 sites Phase 1 Nammi Therapeutics Inc · Los Angeles, California and 10 other locations · NCT06582017

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.