Actively Recruiting
A Clinical Research About CD70-targeted CAR-NKT Cells Therapy in Subjects with Advanced Malignant Solid Tumors
Led by Peking University Cancer Hospital & Institute · Updated on 2024-12-11
13
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
P
Peking University Cancer Hospital & Institute
Lead Sponsor
S
Suzhou Cure Genetics Biosciences Co., Limited.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Clinical Research About CD70-targeted CAR-NKT Cells Therapy in Subjects with Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- ECOG performance status of 0 or 1
- Expected survival time longer than 3 months
- Confirmed advanced malignant solid tumor recurrent or metastatic after at least second-line treatment
- Tumor positive for CD70 by immunohistochemistry
- At least one measurable lesion at baseline per RECIST version 1.1
- Normal basic function of important organs
- Negative pregnancy test for women of childbearing age
- Agreement by men and women to use effective contraception
- Willingness to sign informed consent and participate in the trial
You will not qualify if you...
- Use of cell therapy within the previous one month
- Presence of other malignant tumors within past 2 years except certain cured skin and bladder cancers and breast cancer in situ
- Leptomeningeal or central nervous system metastasis or significant CNS diseases
- Immunotherapy, targeted therapy, or chemotherapy within 5 half-lives or within 2 weeks before cell infusion
- Active hepatitis B, HIV, or hepatitis C infection
- Active or uncontrollable infections
- NYHA heart failure class 2 or higher, uncontrolled hypertension, recent myocarditis or heart attack within 6 months
- Unstable respiratory diseases including interstitial pneumonia
- Uncontrolled ascites or pleural effusion
- Active or uncontrolled autoimmune diseases such as Crohn's disease, rheumatoid arthritis, or lupus
- Use of systemic steroids or steroid inhalers for treatment
- Pregnant or breastfeeding females
- Other conditions deemed unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xinan Sheng Professor, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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