Actively Recruiting
A Clinical Research About CD70-targeted CAR-NKT Cells Therapy for Advanced Malignant Solid Tumors
Led by Fudan University · Updated on 2024-05-01
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying CD70-targeted CAR-NKT cell therapy (CGC729) in adults with advanced malignant solid tumors that are positive for CD70. This Phase 1, open-label, single-arm study aims to evaluate the therapy's safety, effectiveness, and how the body processes the treatment. The study focuses on patients whose tumors have returned or spread after at least two previous treatments. Participants will undergo a lymphodepletion procedure using cyclophosphamide and fludarabine before receiving an infusion of CAR-NKT cells. The treatment involves two possible dose levels of CAR-NKT cells administered after the lymphodepletion. The study plans to enroll 6 to 12 patients, with 3 to 6 patients evaluated per tumor type. During the study, patients will be closely monitored through assessments of tumor response, disease control, duration of response, progression-free survival, and overall survival for up to 56 weeks. Researchers will collect clinical data, perform laboratory tests, and ensure participant safety throughout the treatment and follow-up periods. The total study duration includes treatment and extended observation to evaluate treatment effects and safety.
CONDITIONS
Brief Title
A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- ECOG performance status of 0 to 1
- Expected survival time longer than 3 months
- Advanced malignant solid tumor confirmed by histology or cytology, recurrent or metastatic after at least second-line treatment
- Tumor positive for CD70 by immunohistochemistry
- At least one measurable lesion at baseline according to RECIST version 1.1
- Normal function of important organs including hematopoietic, renal, and liver functions within specified laboratory limits
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception for both men and women
- Informed consent signed indicating understanding and willingness to participate
You will not qualify if you...
- Received cell therapy within one month prior to study
- High risk of severe bleeding in esophageal cancer
- Other malignant tumors within past 2 years except certain cured skin, bladder, or breast cancers
- Leptomeningeal or central nervous system metastasis, or significant CNS diseases within past 6 months
- Immunotherapy, targeted therapy, or chemotherapy within 2 weeks before cell infusion
- Active hepatitis B, HIV, or hepatitis C infection
- Active or uncontrolled infection
- NYHA heart failure class 2 or higher, uncontrolled hypertension, recent myocarditis or myocardial infarction within 6 months
- Unstable respiratory diseases including interstitial pneumonia
- Uncontrolled ascites or pleural effusion
- Active or uncontrolled autoimmune diseases
- Use of systemic steroids or steroid inhalers
- Pregnant or lactating women
- Any condition deemed unsuitable for participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week including preconditioning and infusion
Participants receive a lymphodepleting regimen with cyclophosphamide and fludarabine, followed by infusion of CD70-targeted CAR-NKT cells.
1 visit for leukapheresis, 3 days of lymphodepletion treatment, and 1 infusion visit
Duration - Up to 56 weeks
Participants are monitored for treatment efficacy and safety for up to 56 weeks after infusion.
Regular visits for assessment during follow-up period
Trial Site Locations
Total: 1 location
1
Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Jian Zhang
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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