CD70-targeted CAR-NKT cell therapy 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 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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Xinan Sheng Professor, MD
• Email: doctor_sheng@126.com
• Phone: +86-10-88196348

Similar studies

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

• HEC-921 Injection in adults with advanced solid tumors

  A first-in-human trial tests HEC-921 alone and with other cancer drugs to see how safe it is and how the body handles it in adults with advanced solid tumors.

  Recruiting Phase 1 Sunshine Lake Pharma Co., Ltd. · Shanghai · NCT07824934

• N-3C01 as a standalone treatment and with PD-(L)1 inhibitor in advanced solid tumors

  This study tests N-3C01 alone and with a PD-(L)1 inhibitor to see if it is safe and helps people with advanced solid tumors.

  Recruiting Phase 1/2 Hefei Xinzhu Biological Technology Co., Ltd. · Saint Leonards, New South Wales and 5 other locations · NCT07639450

• First-in-human test of JSKN021 in advanced solid tumors

  This phase 1 study will test the safety and basic activity of JSKN021 in adults with advanced solid tumors who have exhausted standard treatments.

  Recruiting at 10 sites Phase 1 Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Fuzhou, Fujian and 9 other locations · NCT07617727

• JS212 and JS213 alone and in combination for advanced solid tumors

  This trial will test whether JS212 and JS213, given alone or combined with each other or with JS207 or toripalimab, can shrink tumors in people with advanced solid tumors who have progressed after standard treatments.

  Recruiting Phase 2 Shanghai Junshi Bioscience Co., Ltd. · Beijing, Beijing Municipality · NCT07480733

• TPD3310 in patients with advanced malignant solid tumors

  This first-in-human study tests TPD3310 in adults with advanced solid tumors to see if it is safe, tolerable, and shows any signs of activity.

  Recruiting Phase 1 Taibidi Pharmaceutical Technology(shijiazhuang) Co.,ltd. · Beijing, Beijing Municipality · NCT07368127

• JSKN022 for advanced malignant solid tumors

  This will test whether JSKN022 is safe and tolerable for adults with advanced unresectable or metastatic epithelial solid tumors who have exhausted or cannot receive standard treatments.

  Recruiting Phase 1 Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Guangzhou, Guangdong · NCT07292402

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.