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Clinical Trials in China / NCT07500805
Starting soon Phase 1

UCL70805F in Patients With CD70-positive Advanced Renal Clear Cell Carcinoma

NCT07500805 · tracked via the Priya Life Science China tracker
Sponsor
UTC Therapeutics Inc.
Phase
Phase 1
Started
2026-05-01
Last updated
2026-03-30

Condition(s) studied

CD70-positive Advanced Renal Clear Cell Carcinoma

Investigational drug(s) / intervention(s)

UCL70805F

UCL70805F: D0: 5×10\^4 cells ~ 4×10\^5 cells

Study summary

This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of UCL70805F in patients with CD70-positive advanced renal clear cell carcinoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Age from 18 to 75 years old (inclusive), gender is not limited. * Histopathologically confirmed advanced clear cell renal cell carcinoma (ccRCC) that has failed prior standard therapy, or is intolerant to standard therapy, or for which no effective treatment is available. * At least one measurable target lesion as defined by RECIST v1.1. * Fresh solid tumor samples or formalin fixed paraffin embedded tumor archival samples are necessary. * CD70 should be positive confirmed by Immunohistochemistry (IHC) in tumor tissue samples (H-Score \> 100 for CD70 membrane expression). * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Life expectancy ≥ 3 months. * The organ function must meet the protocol requirements. * Female participants of childbearing potential must have a negative pregnancy test. Female participants of childbearing potential or male participants have partners of childbearing potential must agree to use effective contraception throughout the screening period until 1 year after the last cell infusion. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Pregnant or lactating women. * Hepatitis C virus (HCV) antibody positive with quantitative PCR for peripheral blood HCV RNA above the lower limit of detection; human immunodeficiency virus (HIV) antibody positive; or active syphilis infection. * HBV surface antigen (HBsAg) positive and/or HBV core antibody (HBcAb) positive, with HBV-DNA ≥ 500 IU/mL. * Unresolved \> Grade 1 non-hematologic toxicity per CTCAE 5.0 associated with any prior treatments (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.), except for alopecia, peripheral sensory neuropathy. * History of allogeneic tissue/organ transplantation (including bone marrow transplantation, stem cell transplantation, liver transplantation, kidney transplantation, etc.), except for transplants not requiring immunosuppressive therapy (e.g., corneal transplantation, hair transplantation). * Receipt of other CD70-targeted CAR-T cell therapy. * Major surgery procedure without full recovery within 4 weeks prior to signing the informed consent, or a history of severe trauma that have not recovered, or plan to receive major surgery procedure within 12 weeks after cell infusion. * Known central nervous system metastasis lesions, except for the following participants: a. asymptomatic brain metastases; b. clinically stable status (i.e., no radiological progression within 4 weeks prior to cell apheresis, and any neurological symptoms have resolved to baseline level), and have not required corticosteroids or other therapy for brain metastases for ≥ 4 weeks. * Presence of clinically significant systemic disease (e.g., severe active infection or significant dysfunctions of the heart, lungs, liver, nervous system, or other organs), at the discretion of the Investigator, impairs the participant's ability to tolerate the treatment specified in this trial protocol or significantly increases the risk of complications. * History of severe systemic hypersensitivity to the drugs/components used in this trial \[e.g., fludarabine, cyclophosphamide, dimethyl sulfoxide (DMSO), low molecular weight dextran, human serum albumin (HSA)\]. * Receipt of live attenuated vaccine within 4 weeks prior to signing informed consent. * Participation in another clinical trial within 4 weeks prior to signing informed consent. * History of another malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ (e.g., breast, stomach, colon, cervix, etc.). * History of neuropsychiatric disorders diagnosed per ICD-11 criteria, or any neuropsychiatric disorder requiring exclusion as determined by the investigator, including but not limited to epilepsy, schizophrenia, dementia, or drugs/alcohol addiction. * Any other condition that, in the investigator's opinion, makes the patient unsuitable for participating in this trial.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

More UTC Therapeutics Inc. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07500805 on ClinicalTrials.gov ↗ ← All trials in China