NCT05947487 CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors
| NCT ID | NCT05947487 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-07-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-07-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive advanced/metastatic solid tumors . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 (inclusive). 2. ECOG performance status ≤2 and Estimated life expectancy of more than 3 months. 3. Histopathological confirmed advanced or metastatic solid tumors failed to at least first-line treatment or initially diagnosed advanced/metastatic solid tumors that have no NCCN guideline recommended standard first-line therapy. CD70 antigen expression level ≥ 30%. 4. At least one measurable lesion at baseline per RECIST version 1.1. 5. Fresh solid tumor samples or formalin-fixed paraffin embedded tumor archival samples within 6 months are necessary; Fresh tumor samples are preferred. Subjects are willing to accept tumor rebiopsy in the process of this study. 6. Adequate organ function as defined by the following criteria: ANC≥1.5x10\^9/L; Platelet count ≥75x10\^9/L; Hemoglobin ≥90 g/L;Serum AST and serum ALT, ≤3.0 x ULN (≤5 x ULN for patients with liver cancer or metastases); Total serum bilirubin ≤1.5 x ULN(≤3 x ULN for patients with liver cancer or metastases); Serum creatinine ≤1.5 xULN or creatinine clearance of ≥60 mL/min. 7. Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year. 8. Ability to understand and sign a written informed consent documen. Exclusion Criteria: 1. Subjects are being treated with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. 2. Received cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives before enrollment; 3. Pregnant, lactating, or breastfeeding females; 4. Known positive test result for human immunodeficiency virus (HIV) oracquired immune deficiency syndrome (AIDS);Active infection of hepatitis B virus (HBV), or hepatitis C virus (HCV); 5. History of allergy or intolerance to study drug components; 6. Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation; 7. Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered. 8. Known brain metastases or active central nervous system (CNS).Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening. 9. Previous or concurrent cancer within 5 years prior to treatment start except for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors; 10. Any serious underlying medical (eg, pulmonary, renal, hepatic,gastrointestinal, or neurological) or psychiatric condition or any issue that would limit compliance with study requirements; 11. Vaccination within 30 days of study enrollment; 12. Previously received CD70-CAR T cell therapy; 13. Being participating any other trials or withdraw within 4 weeks; 14. Researchers believe that other reasons are not suitable for clinical trials.
Contact & Investigator
Yangbin Zhao, Ph.D
STUDY DIRECTOR
UTC Therapeutics Inc.
Frequently Asked Questions
Who can join the NCT05947487 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05947487 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05947487 currently recruiting?
Yes, NCT05947487 is actively recruiting participants. Contact the research team at hanwdrsw@sina.com for enrollment information.
Where is the NCT05947487 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05947487 clinical trial?
NCT05947487 is sponsored by Chinese PLA General Hospital. The principal investigator is Yangbin Zhao, Ph.D at UTC Therapeutics Inc.. The trial plans to enroll 30 participants.