Actively Recruiting
Anti-CD70-CAR-T Cell Injection for the Treatment of Locally Advanced or Relapsed/Metastatic CD70+ Inoperable Renal Cells
Led by Shanghai Changzheng Hospital · Updated on 2024-10-22
9
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
Sponsors
S
Shanghai Changzheng Hospital
Lead Sponsor
S
Shanghai First Song Biotechnology Co., LTD
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an investigator-initiated trial to evaluate the role of anti-CD70-CAR T cells in locally advanced or recurrent/metastatic renal cell carcinoma that is inoperable.
CONDITIONS
Official Title
Anti-CD70-CAR-T Cell Injection for the Treatment of Locally Advanced or Relapsed/Metastatic CD70+ Inoperable Renal Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and sign informed consent, and voluntarily participate in clinical research
- Age 18 to less than 70 years, any gender
- Histopathologically or cytologically confirmed advanced malignant renal cell carcinoma that is CD70 positive
- Prior treatment with at least VEGFR-targeted therapy and immune checkpoint therapy
- At least one measurable lesion smaller than 6 cm according to RECIST 1.1
- Expected survival of at least 12 weeks
- ECOG performance status of 0 to 2
- Adequate blood cell counts without recent transfusions or growth factor therapy as specified
- Adequate liver function within defined limits
- Adequate kidney function with creatinine clearance above 50 mL/min
- Left ventricular ejection fraction of 50% or higher
- No resting dyspnea and pulse oximetry above 93% without oxygen
- Coagulation tests (APTT and INR) within 1.5 times the upper limit of normal
- Good venous access for apheresis and no contraindications for blood cell separation
- Negative pregnancy test for women of childbearing age and agreement to use effective contraception during study and for 12 months after
You will not qualify if you...
- Previous use of any CAR T cell or genetically modified T cell therapy
- History of allogeneic stem cell or solid organ transplantation or awaiting transplantation
- Acute or uncontrolled active infection requiring IV anti-infective therapy
- Active hepatitis B, hepatitis C, syphilis, or HIV infection
- Low blood sodium (<125 mmol/L) or potassium (<3.5 mmol/L) unless corrected before participation
- Liver tumor involvement of 50% or more
- Clinically uncontrollable third space effusion deemed unsuitable
- Prior anti-CD70 therapy
- Continuous systemic steroid use above specified doses within defined timeframes
- Unresolved toxicity from previous anticancer therapy above grade 1 except certain conditions
- Recent anticancer therapies not meeting washout periods
- Other active or recent malignancies except certain cured or inactive cancers
- History or current central nervous system tumors or diseases affecting safety
- Uncontrolled hypertension, unstable angina, severe heart failure, serious ECG abnormalities
- Severe respiratory diseases or extensive lung radiation
- Active or past autoimmune diseases with recurrence risk except specified exceptions
- Serious systemic diseases or conditions affecting study compliance or safety
- Recent major surgery or trauma within 4 weeks before apheresis
- Allergies or intolerance to study treatments or related agents including fludarabine and cyclophosphamide
- Pregnant or breastfeeding women or planning pregnancy
- Unable or unwilling to comply with study protocols
- Involvement in planning or conducting the research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changzheng hospital
Shanghai, Shanghai Municipality, China, 201109
Actively Recruiting
Research Team
S
Shancheng Ren, MD,PhD
CONTACT
Z
Zhixiang Xin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here