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New treatment option for Renal Cell Carcinoma
Official title Anti-CD70-CAR-T Cell Injection for the Treatment of Locally Advanced or Relapsed/Metastatic CD70+ Inoperable Renal Cells
ClinicalTrials.gov ID: NCT06586658
What this study is testing
What is anti-CD70-CAR-T cells?
anti-CD70-CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for renal cell carcinoma.
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 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.
- 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 70
You may be able to join if
- Understand and sign informed consent, and voluntarily participate in clinical research;
- Age ≥18, and \<70 years old, gender is not limited;
- Histopathologically or cytologically confirmed advanced malignant renal cell carcinoma of CD70+ with at least VEGFR-targeted therapy and an immune...
- At least one measurable lesion with a maximum diameter of less than 6 cm according to RECIST 1.1;
- Expected survival ≥12 weeks;
You likely can't join if
- Patients are not eligible to participate in this trial if they meet any of the following conditions:
- Previous use of any CAR T cell products or other genetically modified T cell therapy;
- Patients who have a history of allogeneic stem cells or solid organ transplantation or are waiting for organ transplantation;
- Patients with acute or uncontrolled active infection who currently require intravenous anti-infective therapy, and patients taking antibiotics to...
- Active hepatitis B (hepatitis B surface antigen positive and hepatitis B DNA\>103 copies /mL or \>200IU/mL), active hepatitis C (hepatitis C antibody...
- Patients with low sodium and/or hypokalemia with blood sodium \<125mmol/L and/or blood potassium \<3.5mmol/L (unless sodium and/or potassium...
See the full eligibility criteria
Who can join
- Understand and sign informed consent, and voluntarily participate in clinical research;
- Age ≥18, and \<70 years old, gender is not limited;
- Histopathologically or cytologically confirmed advanced malignant renal cell carcinoma of CD70+ with at least VEGFR-targeted therapy and an immune checkpoint therapy (either combination therapy or sequential therapy);
- At least one measurable lesion with a maximum diameter of less than 6 cm according to RECIST 1.1;
- Expected survival ≥12 weeks;
- ECOG score ≤2 points;
- Have sufficient hematologic function and have not received blood transfusion or cell growth factor therapy within 7 days prior to the hematologic evaluation during the screening period (2 weeks interval is required for...
- Neutrophil absolute value ≥1.5×109/L
- Hemoglobin ≥80g/L
- Platelets ≥75×109/L
- Lymphocytes (ALC) ≥0.3×109/L
- Adequate liver function: serum total bilirubin ≤1.5× upper limit of normal (ULN) (for Gilbert syndrome patients, total bilirubin ≤3×ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN; If...
- Adequate renal function: creatinine ≤1.5×ULN or endogenous creatinine clearance ≥50 mL/min (using Cockcroft Gault formula);
- Left ventricular ejection fraction (LVEF) of echocardiography was ≥50%.
- There was no evidence of dyspnea at rest and pulse oximetry was \>93% without oxygen.
- Activated partial thromboplastin time (APTT) ≤1.5×ULN and International normalized ratio (INR) ≤1.5×ULN;
- Good venous access (for apheresis) and no other contraindications for blood cell separation;
- Pregnancy tests for women of childbearing age must be negative. All people must agree to use an effective contraceptive method at the same time from the time of signing the informed consent to 12 months after the final...
What rules you out
- Patients are not eligible to participate in this trial if they meet any of the following conditions:
- Previous use of any CAR T cell products or other genetically modified T cell therapy;
- Patients who have a history of allogeneic stem cells or solid organ transplantation or are waiting for organ transplantation;
- Patients with acute or uncontrolled active infection who currently require intravenous anti-infective therapy, and patients taking antibiotics to prevent infection should be allowed to participate in the study at the...
- Active hepatitis B (hepatitis B surface antigen positive and hepatitis B DNA\>103 copies /mL or \>200IU/mL), active hepatitis C (hepatitis C antibody positive and RNA positive); Active syphilis infection (RPR or...
- Patients with low sodium and/or hypokalemia with blood sodium \<125mmol/L and/or blood potassium \<3.5mmol/L (unless sodium and/or potassium supplementation is required prior to study participation to restore blood...
- Imaging results showed that the proportion of liver replaced by tumor was ≥50%;
- There was clinically uncontrollable third space effusion, which was judged by the researcher not suitable for inclusion;
- Previously received anti-CD70 therapy;
- Receiving continuous systemic steroid medication (prednisone \> 10mg/ day or equivalent dose of other hormones) within 14 days of preapheresis or 3 days before cell therapy, except for recent or current topical steroid...
- Toxicity from previous antitumor therapy has not recovered (\>CTCAE version 5.0 Grade 1), except for alopecia, pigmentation, and other tolerable events as determined by the investigator or laboratory abnormalities...
- The eluting period of preaphermative antitumor therapy met the following requirements:
- ≦2 weeks or 5 half-lives of chemotherapy, small molecule targeted therapy, radiotherapy, endocrine therapy, immunomodulatory therapy, and Chinese medicine with anti-tumor indications
- ≦4 weeks of macromolecular targeted therapy and immunotherapy
- ≦4 weeks of anti-tumor vaccine
- ≦4 weeks of investigational medication/therapy
- Previous or current co-occurrence of other malignancies (other than basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix and other malignancies that have been cured or are free of disease and have...
- Previous history of primary or secondary tumors of the central nervous system (CNS) (except stable ≥4 weeks after treatment, no current CNS related signs and no drug control ≥14 days);
- Patients with other central nervous system diseases (such as seizures, cerebral hemorrhage, dementia, etc.) that researchers have judged may affect the safety of people;
- Uncontrolled hypertension (systolic blood pressure ≥150 MMHG and/or diastolic blood pressure ≥95mmHg after standard treatment), unstable angina, congestive heart failure of New York Heart Association grade III or...
- Patients with severe respiratory diseases, such as interstitial lung disease, active pulmonary tuberculosis, and patients who have received extensive radiation therapy in the lung, were not considered suitable for...
- Patients with active or past autoimmune diseases with the possibility of recurrence (e.g. systemic lupus erythematosus, rheumatoid arthritis, etc.), except for type 1 diabetes, hypothyroidism requiring hormone...
- In the investigator's judgment, any serious or uncontrollable systemic disease, systemic comorbiditis, other serious comorbiditis (such as hemophagic cell syndrome, etc.), or special conditions of the tumor may make the...
- Had any major surgery (other than exploratory laparotomy or laparoscopic exploration) or severe trauma within 4 weeks prior to apheresis, had major surgery scheduled during DLT observation, or had not fully recovered...
- Patients who are allergic to or intolerant to antisepsis agents that may be used during the study or to medications that are appropriate for the treatment of CRS, including but not limited to fludarabine and...
- Women who are pregnant, who plan to become pregnant during the trial, or who are breastfeeding;
- Patients judged by the investigator to be unable or unwilling to comply with clinical protocols;
- Persons involved in the planning and execution of the research.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.