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

A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects with Advanced Malignant Solid Tumors

This study is testing a new treatment using modified 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: 13 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (Academic / other)
• Drugs / interventions: chemotherapy, Immunotherapy, cyclophosphamide, fludarabine
• Locations: 1 site (Beijing)
• Trial ID: NCT06728189 on ClinicalTrials.gov

What this trial studies

This phase I clinical research evaluates the safety and efficacy of CD70-targeted CAR-NKT cell therapy in patients with advanced malignant solid tumors. The study involves a dose-escalation and dose-expansion design, enrolling 13 to 23 patients who have CD70-positive tumors. Participants will receive escalating doses of CGC738, with safety monitored through dose-limiting toxicity assessments. The goal is to identify the maximum tolerated dose while ensuring patient safety and assessing antitumor activity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with CD70-positive advanced malignant solid tumors who have undergone at least second-line treatment.

Not a fit: Patients with other malignant tumors within the past 2 years or those who have received cell therapy within the last month 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 malignant solid tumors that express CD70.

How similar studies have performed: While this approach is innovative, similar studies targeting specific antigens with CAR therapies have shown promise in other malignancies.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 75 years.
2. ECOG 0-1 points.
3. The expected survival time is more than 3 months.
4. Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
5. IHC: CD70 positive.
6. At least one measurable lesion at baseline per RECIST version 1.1.
7. The functions of important organs are basically normal:
8. Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.
9. 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:

1. Use of cell therapy within the previous one month.
2. 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.
3. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.
4. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
5. Active hepatitis B, HIV positive and HCV positive.
6. Active infection or uncontrollable infection.
7. 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.
8. Unstable respiratory diseases, including interstitial pneumonia.
9. Uncontrolled ascites and pleural effusion
10. Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .
11. Subjects who are using systemic steroids or steroid inhalers for treatment.
12. Pregnant or lactating female subjects.
13. Other investigators deem it unsuitable to participate in the study.

Where this trial is running

Beijing

• Beijing Cancer Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xinan Sheng Professor, MD

Conditions Advanced Malignant Solid Tumors