Advanced Clear Cell Renal Cell CarcinomaPhase 1NCT06870279
A Clinical Research of CD70-targeted CAR-NKT Cells (CGC738) Therapy in RCC
A Phase 1 study testing CGC738 in people with Advanced Clear Cell Renal Cell Carcinoma, run by RenJi Hospital.
Trial summary
This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced clear cell renal cell carcinoma (ccRCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Clear Cell Renal Cell Carcinoma
- What is being tested?
- CGC738
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2025to 31 Dec 2026
- 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
- 1. Age 18 to 75 years.
- 2.ECOG 0-1 points.
- 3. The expected survival time is more than 3 months.
- 4. Patients with advanced ccRCC confirmed by histology or cytology to be recurrent or metastatic after at least first-line treatment.
- 5. IHC: CD70 positive.
- 6. At least one measurable lesion at baseline per RECIST version 1.1.
- 7. The functions of important organs are basically normal:
- 8. Pregnancy tests for women of childbearing age shall be negative, both men and women agreed to use effective contraception.
Who cannot join
- 1. Use of cell therapy within the previous one month.
- 2. Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.
- 3. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.
- 4. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
- 5. Active hepatitis B, HIV positive and HCV positive.
- 6. Active infection or uncontrollable infection.
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- 7. Uncontrollable or significant heart disease.
- 8. Unstable respiratory diseases, including interstitial pneumonia.
- 9. Uncontrolled ascites and pleural effusion.
- 10.Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc.
- 11.Subjects who are using systemic steroids or steroid inhalers for treatment.
- 12.Pregnant or lactating female subjects.
- 13.Other investigators deem it unsuitable to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects With Advanced Clear Cell Renal Cell Carcinoma
This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced clear cell renal cell carcinoma (ccRCC).
Read the detailed description
This is a single-arm, open-label study. This study will include two parts, dose escalation phase (3+3 design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by CAR-T cell injection.
Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of anti-CD70 CAR-T cell injection.
- Conditions
- Advanced Clear Cell Renal Cell Carcinoma
- Being tested
- CGC738
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGC738Drug
CAR-NKT Cells treatment
| Study group | Role | What they receive |
|---|---|---|
| CAR-NKT Cells Lymphodepleting regimen | Experimental | CAR-NKT Cells treatment Receives: Drug: CGC738 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Dose limiting toxicity (DLT) is an AE that meets the following criteria and occurs within 28 days of CGC738 infusion.AE is graded according to CTCAE version 5.0.
Measured: Day 28 after CGC738 infusion
Secondary outcomes (3)
ORR
Assess Objective response rate
Measured: Day 1 through week 56
DCR
Assess Disease control rate
Measured: Day 1 through week 56
AEs
Incidence of adverse events
Measured: Day 1 through week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start25 May 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870279
- Sponsor's protocol ID
- CGC738-IIT-02
- Status last verified
- Apr 2025
- First submitted
- 5 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects With Advanced Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06870279
- Acronym / sponsor ID
- CGC738-IIT-02
- Conditions
- Advanced Clear Cell Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (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 phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced clear cell renal cell carcinoma (ccRCC).
Detailed description
This is a single-arm, open-label study. This study will include two parts, dose escalation phase (3+3 design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by CAR-T cell injection.
Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of anti-CD70 CAR-T cell injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-NKT Cells Lymphodepleting regimen | Experimental | Drug: CGC738CAR-NKT Cells treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Age 18 to 75 years.
- 2.ECOG 0-1 points.
- 3. The expected survival time is more than 3 months.
- 4. Patients with advanced ccRCC confirmed by histology or cytology to be recurrent or metastatic after at least first-line treatment.
- 5. IHC: CD70 positive.
Key exclusion criteria (13 listed)
- 1. Use of cell therapy within the previous one month.
- 2. Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.
- 3. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.
- 4. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
- 5. Active hepatitis B, HIV positive and HCV positive.
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 |
|---|---|---|
| CGC738CAR-NKT Cells treatment | Drug | CAR-NKT Cells Lymphodepleting regimen |
Primary outcome
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Time frame: Day 28 after CGC738 infusion
Dose limiting toxicity (DLT) is an AE that meets the following criteria and occurs within 28 days of CGC738 infusion.AE is graded according to CTCAE version 5.0.
3 secondary outcomes
ORR
Time frame: Day 1 through week 56
DCR
Time frame: Day 1 through week 56
AEs
Time frame: Day 1 through week 56
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 24 Apr 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CGC738 in people with Advanced Clear Cell Renal Cell Carcinoma, run by RenJi Hospital.
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 8 inclusion and 13 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Zhai Wei (+8618701771959, jackyzw2007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) (time frame: Day 28 after CGC738 infusion). 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 24 Apr 2025.