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

March 24, 2026 updated by: UTC Therapeutics Inc.

An Exploratory Clinical Study to Evaluate the Safety and Preliminary Efficacy of UCL70805F in the Treatment of Patients With CD70-positive Advanced Renal Clear Cell Carcinoma

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will include two parts, dose escalation phase (modified "3+3" design) followed by a dose expansion phase.

All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by a single intravenous infusion of UCL70805F. The recommended phase 2 dose (RP2D) will be determined during the dose escalation phase. In the dose expansion phase, one or two dose levels may be selected to further characterize the safety profile and evaluate the efficacy of UCL70805F.

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: UCL70805F
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by UCL70805F.
Biological: UCL70805F
D0: 5×10^4 cells ～ 4×10^5 cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: 2 years
Incidence and severity of adverse events.
2 years
Serious Adverse Events (SAEs)
Time Frame: 2 years
Incidence and severity of serious adverse events.
2 years
Dose-limiting Toxicities (DLTs)
Time Frame: 4 weeks
Incidence and severity of dose-limiting toxicities (DLTs) following infusion of UCL70805F, at each dose level tested in dose escalation phase.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 2 years
The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
2 years
Disease Control Rate (DCR)
Time Frame: 2 years
Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
2 years
Cytokine Level in Peripheral Blood
Time Frame: 2 years
Level of cytokines in serum.
2 years
Progression-Free Survival (PFS)
Time Frame: 2 years
PFS is defined as the time from UCL70805F infusion to the date of the disease progression or death from any cause.
2 years
Overall Survival (OS)
Time Frame: 2 years
OS is defined as the time from UCL70805F infusion to the date of death due to any cause.
2 years
CAR copies in Peripheral Blood
Time Frame: 2 years
CAR copies will be measured by qPCR to evaluate the expansion and persistence of UCL70805F in vivo.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UTC Therapeutics Inc.

Collaborators

The First Affiliated Hospital of Zhengzhou University

Investigators

  • Principal Investigator: Yi Zhang, The First Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL70805F-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on CD70-positive Advanced Renal Clear Cell Carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe