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Suspended
NCT06586658
Anti-CD70-CAR-T Cell Injection for the Treatment of Locally Advanced or Relapsed/Metastatic CD70+ Inoperable Renal Cells
Conditions: Renal Cell Carcinoma
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 9
Sponsor: Shanghai Changzheng Hospital
Location: Changzheng hospital Shanghai Shanghai Municipality
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Understand and sign informed consent, and voluntarily participate in clinical research;
2. Age ≥18, and \93% without oxygen.
12. Activated partial thromboplastin time (APTT) ≤1.5×ULN and International normalized ratio (INR) ≤1.5×ULN;
13. Good venous access (for apheresis) and no other contraindications for blood cell separation;
14. Pregnancy tests for women of childbearing age must be negative. All subjects 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 administration of the study drug.
Exclusion Criteria:
Patients are not eligible to participate in this trial if they meet any of the following conditions:
1. Previous use of any CAR T cell products or other genetically modified T cell therapy;
2. Patients who have a history of allogeneic stem cells or solid organ transplantation or are waiting for organ transplantation;
3. 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 discretion of the investigator;
4. 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 TRUst-positive), human immunodeficiency virus (HIV) infection (HIV positive);
5. Patients with low sodium and/or hypokalemia with blood sodium \CTCAE version 5.0 Grade 1), except for alopecia, pigmentation, and other tolerable events as determined by the investigator or laboratory abnormalities permitted under the protocol;
11. 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
12. 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 not been treated in the past five years);
13. 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);
14. Patients with other central nervous system diseases (such as seizures, cerebral hemorrhage, dementia, etc.) that researchers have judged may affect the safety of subjects;
15. 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 higher, or significant abnormalities on ECG, Severe arrhythmias requiring treatment and a history of myocardial infarction within 6 months prior to initiation of study therapy;
16. 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 inclusion by researchers;
17. 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 replacement therapy, skin diseases without systemic treatment (e.g. vitiligo, psoriasis or alopecia);
18. 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 patient unfit to enter the study or affect protocol compliance, or significantly interfere with the correct evaluation of the safety, toxicity, and effectiveness of the investigatory drugs;
19. 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 from any previous invasive procedure;
20. 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 cyclophosphamide or toluzumab; Known to be allergic to anti-CD70-CAR-T ingredients; Or have any history of severe allergies, such as anaphylactic shock;
21. Women who are pregnant, who plan to become pregnant during the trial, or who are breastfeeding;
22. Patients judged by the investigator to be unable or unwilling to comply with clinical protocols;
23. Persons involved in the planning and execution of the research.
Source: ClinicalTrials.gov (NCT06586658). StuddyBuddy aggregates publicly available trial information.