A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors

Launched by ZHEJIANG UNIVERSITY · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called anti-CD70 UCAR-T cells for patients with specific types of advanced solid tumors that have not responded to previous therapies. The goal is to determine how safe and effective this treatment is and to find the right dosage for patients. The study will include adults aged 18 and older who have been diagnosed with certain cancers, such as renal cell carcinoma, ovarian cancer, or cervical cancer, and who have not had success with at least two prior treatments.

To be eligible for the trial, participants need to have tumors that show positive levels of a specific protein called CD70 and must have at least one measurable tumor lesion. They should also be in reasonably good health and expected to survive for at least 12 weeks. Participants will receive the UCAR-T cell treatment and will be closely monitored for any side effects and results. It’s important to note that this trial is not yet recruiting participants, so anyone interested should stay informed about when enrollment begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ability to understand and sign a written informed consent documen；
• • 2. Age ≥18 years old, male or female；
• • 3. Histopathological confirmed advanced or metastatic solid tumors failed to at least second-line treatment or initially diagnosed advanced/metastatic solid tumors that have no NCCN guideline recommended standard first-line therapy；
• • 4. Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor CD70 expression (tumor CD70 positive (IHC 2+) confirmed by histology or pathology));
• • 5. At least one measurable lesion at baseline per RECIST version 1.1；
• • 6. The expected survival time is more than 12 weeks;
• • 7. ECOG 0-1 points;
• 8. The function of important organs is basically normal:Hematopoietic function:
• • Hematopoietic function: neutrophils ≥ 1.5×109/L, platelets ≥ 90×109/L, hemoglobin ≥ 90g/dL;
• • Renal function: serum creatinine≤1.5×ULN;
• • WBC≥3.0×109/L,
• • Liver function: Total bilirubin ≤ 1.5×ULN(Except Gilbert syndrome), extrahepatic metastasis：ALT and AST ≤ 3.0×ULN (Nonhepatic metastasis：it can be relaxed to ≤ 5.0×ULN);
• • coagulation function：INR≤1.5×ULN，APTT≤1.5×ULN
• • 9. Subjects agree to use reliable and effective contraceptive methods for contraception within 6 months after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception);
• Exclusion Criteria:
• • 1. Received anti-CD70 drug treatment before screening;
• • 2. Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is longer) before Received;
• • 3. Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks prior to Received；
• • 4. Pregnant, lactating, or breastfeeding females;
• • 5. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA titer test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive; cytomegalovirus (CMV) DNA test positive;
• 6. Have any of the following heart conditions:
• • New York Heart Association (NYHA) stage III or IV congestive heart failure; Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment; Clinically significant ventricular arrhythmia, echocardiography showed cardiac ejection fraction\<50%,
• • 7. Active/symptomatic central nervous system metastases or meningeal metastases at the time of screening; subjects with brain metastases who have been treated must be confirmed to have no imaging evidence of progression ≥ 4 weeks after the end of treatment before they can be enrolled;
• • 8. Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation;
• • 9. Vaccination within 14 days of study enrollment;
• • 10. Received live attenuated vaccine within 4 weeks before screening;
• • 11. Malignant tumors other than the target tumor within 3 years prior to screening, except for the following: malignant tumors that have received radical treatment and no known active disease within ≥ 3 years prior to enrollment;
• • 12. Other investigators deem it inappropriate to participate in the study.
• • 13. Serious or uncontrollable systemic disease or any unstable systemic disease, including but not limited to uncontrolled hypertension, uncontrolled hyperglycemia, liver and kidney insufficiency or metabolic disease, central nervous system disease, etc