CD70-targeted CAR-NKT cell therapy for advanced solid tumors

A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors

This study is testing a new therapy using special immune cells to see if it can help people with advanced solid tumors that have a specific marker called CD70.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, Immunotherapy, cyclophosphamide, fludarabine
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06394622 on ClinicalTrials.gov

What this trial studies

This phase I clinical research evaluates the safety and efficacy of CGC729, a therapy using CD70-targeted CAR-NKT cells, in patients with advanced malignant solid tumors. The study aims to enroll 6 to 12 patients with CD70-positive tumors, utilizing leukapheresis for cell collection and a lymphodepletion regimen of fludarabine and cyclophosphamide. The treatment will be assessed for its ability to improve patient outcomes in this challenging cancer population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with CD70-positive advanced malignant solid tumors that have progressed after at least two lines of treatment.

Not a fit: Patients with solid tumors that do not express CD70 or those with significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel treatment option for patients with advanced solid tumors that express CD70.

How similar studies have performed: While CAR-T cell therapies have shown success in hematological malignancies, this approach targeting solid tumors is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Age 18 to 75 years.
* ECOG 0-1 points.
* The expected survival time is more than 3 months.
* Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
* IHC: CD70 positive.
* At least one measurable lesion at baseline per RECIST version 1.1.
* The functions of important organs are basically normal:Hematopoietic function:

neutrophils 1.5×109/L, platelets 75×109/L, hemoglobin 80g/L;Renal function: creatinine clearance of ≥60 mL/min.;Liver function: ALT and AST ≤2.5×ULN (≤5 × ULN for patients with liver metastases);Total bilirubin ≤1.5×ULN.Prothrombin time (PT) : INR \< 1.7.

* Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.
* Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.

Exclusion Criteria:

* Use of cell therapy within the previous one month.
* Risk of severe bleeding in esophageal cancer
* Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.
* Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms in the past 6 months.
* Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
* Active hepatitis B, HIV positive and HCV positive
* Active infection or uncontrollable infection.
* Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standard therapy requiring special treatment, previous history of myocarditis, or myocardial infarction within 6 months.
* Unstable respiratory diseases, including interstitial pneumonia.
* Uncontrolled ascites and pleural effusion
* Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .
* Subjects who are using systemic steroids or steroid inhalers for treatment.
* Pregnant or lactating female subjects.
* Other investigators deem it unsuitable to participate in the study.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jian Zhang — Fudan University
• Study coordinator: Jian Zhang

Conditions Solid Tumor