NCT06394622 A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors
| NCT ID | NCT06394622 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Fudan University |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-04-11 |
| Primary Completion | 2026-06-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-04-11 with a primary completion date of 2026-06-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC729 in the treatment of advanced malignant solid tumors. Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I
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.
Contact & Investigator
Jian Zhang
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06394622 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06394622 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06394622 currently recruiting?
Yes, NCT06394622 is actively recruiting participants. Contact the research team at syner2000@163.com for enrollment information.
Where is the NCT06394622 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06394622 clinical trial?
NCT06394622 is sponsored by Fudan University. The principal investigator is Jian Zhang at Fudan University. The trial plans to enroll 12 participants.