CD70-positive Advanced Renal Clear Cell CarcinomaPhase 1NCT07500805
UCL70805F in Patients With CD70-positive Advanced Renal Clear Cell Carcinoma
A Phase 1 study testing UCL70805F in people with CD70-positive Advanced Renal Clear Cell Carcinoma, run by UTC Therapeutics Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CD70-positive Advanced Renal Clear Cell Carcinoma
- What is being tested?
- UCL70805F
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 May 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Yi Zhang, 15138928971, yizhang001@163.com
Xinfeng Chen, fengxinchen1985@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- UCL70805F
- Keywords
- Anti-CD70 CAR-T, Renal Clear Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCL70805FBiological
D0: 5×10^4 cells ～ 4×10^5 cells
| Study group | Role | What they receive |
|---|---|---|
| Experimental: UCL70805F | Experimental | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by UCL70805F. Receives: Biological: UCL70805F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Incidence and severity of adverse events.
Measured: 2 years
Serious Adverse Events (SAEs)
Incidence and severity of serious adverse events.
Measured: 2 years
Dose-limiting Toxicities (DLTs)
Incidence and severity of dose-limiting toxicities (DLTs) following infusion of UCL70805F, at each dose level tested in dose escalation phase.
Measured: 4 weeks
Secondary outcomes (6)
Objective Response Rate (ORR)
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.
Measured: 2 years
Disease Control Rate (DCR)
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.
Measured: 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from UCL70805F infusion to the date of the disease progression or death from any cause.
Measured: 2 years
Overall Survival (OS)
OS is defined as the time from UCL70805F infusion to the date of death due to any cause.
Measured: 2 years
CAR copies in Peripheral Blood
CAR copies will be measured by qPCR to evaluate the expansion and persistence of UCL70805F in vivo.
Measured: 2 years
Cytokine Level in Peripheral Blood
Level of cytokines in serum.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD70-positive Advanced Renal Clear Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Modified "3+3" design dose escalation phase followed by dose expansion phase
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UTC Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Zhang, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500805
- Sponsor's protocol ID
- UCL70805F-001
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07500805
- Acronym / sponsor ID
- UCL70805F-001
- Keywords
- Anti-CD70 CAR-T, Renal Clear Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- UTC Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Modified "3+3" design dose escalation phase followed by dose expansion phase
| Arm | Type | Receives |
|---|---|---|
| Experimental: UCL70805F | Experimental | Biological: UCL70805FA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by UCL70805F. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCL70805FD0: 5×10^4 cells ～ 4×10^5 cells | Biological | Experimental: UCL70805F |
Primary outcome
Adverse Events (AEs)
Time frame: 2 years
Incidence and severity of adverse events.
Serious Adverse Events (SAEs)
Time frame: 2 years
Incidence and severity of serious adverse events.
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.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
CAR copies in Peripheral Blood
Time frame: 2 years
Cytokine Level in Peripheral Blood
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi Zhang principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UCL70805F in people with CD70-positive Advanced Renal Clear Cell Carcinoma, run by UTC Therapeutics Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang (15138928971, yizhang001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.