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New treatment option for Advanced Malignant Solid Tumors
Official title A Clinical Research About CD70-targeted CAR-NKT Cells Therapy in Subjects with Advanced Malignant Solid Tumors
ClinicalTrials.gov ID: NCT06728189
What this study is testing
What is CAR-NKT Cells treatment?
CAR-NKT Cells treatment is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced malignant solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced malignant solid tumors. Condition or disease：advanced malignant solid tumors Intervention/treatment：Biological: CD70 CAR-NKT cells Phase：Phase 1
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- IHC: CD70 positive.
You likely can't join if
- Use of cell therapy within the previous one month.
- people with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in...
- Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with...
- 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.
See the full eligibility 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:
- Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.
- people 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.
- Use of cell therapy within the previous one month.
- people 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.
- 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.
- people 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. .
- people who are using systemic steroids or steroid inhalers for treatment.
- Pregnant or lactating female people.
- Other investigators deem it unsuitable to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.