Renal Cell CarcinomaPhase 1NCT06182735
CD70-targeted CAR-NKT Cells(CGC729) Therapy in the Renal Cell Carcinoma
A Phase 1 study testing Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells in people with Renal Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
This is a phase I, open-label, single-arm study conducted to evaluate the safety, tolerability, PK, and preliminary efficacy of CGC729 with Relapsed or Metastatic advanced renal cell carcinoma. Condition or disease:Renal Cell Carcinoma Intervention/treatment: Biological: CD70 CAR-NKT cells Phase 1 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2023to 28 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.
- Age 18 to 75 years.
- Patients with advanced clear cell renal cell carcinoma confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
- Archival and/or fresh tumor tissue samples are required.
- At least one measurable lesion at baseline per RECIST version 1.1.
- ECOG 0-1 points.
Show all 9Show fewer
- The expected survival time is more than 12 weeks.
- The functions of important organs are basically normal: Hematopoietic function: neutrophils 1.5×109/L, platelets 75×109/L, hemoglobin 80g/L; Renal function: creatinine clearance of ≥60 mL/min.; Liver function: ALT and AST≤2.5×ULN (≤5 × ULN for patients with liver metastases); Total bilirubin≤1.5×ULN. Coagulation INR < 1.7.
- Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.
Who cannot join
- Pregnant or lactating female subjects.
- Pregnant or lactating female subjects.
- Known positive test result for human immunodeficiency virus (HIV) oracquired immune deficiency syndrome (AIDS).
- Active infection or uncontrollable infection.
- Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .
- Having a history of any mental illness, including dementia, altered mental status, which may affect informed consent and the understanding of the subject by the relevant questionnaire.
Show all 16Show fewer
- Have a serious uncontrollable illness that may affect the subject receiving treatment for this study.
- 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.
- Subjects who are using systemic steroids or steroid inhalers for treatment.
- Use of anti-CD70 therapy or cell therapy within the previous 3 months.
- Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
- Subjects allergic to immunotherapy or related drugs.
- Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms in the past 6 months.
- Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standard therapy requiring special treatment, previous history of myocarditis, or myocardial infarction within 6 months.
- Earnestly received or organ transplantation or preparing to receive organ transplants.
- Other investigators deem it unsuitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jian Zhang
Shanghai
Jian Zhang, 18017312991, syner2000@163.com
Dingwei Ye, 021-64175590, ydw@163.com
About this study
Official title: A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-NKT in the Treatment of Relapsed or Metastatic Advanced Renal Cell Carcinoma.
This is a phase I, open-label, single-arm study conducted to evaluate the safety, tolerability, PK, and preliminary efficacy of CGC729 with Relapsed or Metastatic advanced renal cell carcinoma.
Condition or disease:Renal Cell Carcinoma Intervention/treatment: Biological: CD70 CAR-NKT cells Phase 1
Read the detailed description
Dose exploration for this study will be a 3+3 design with a target DLT rate of <1/3. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. Dose exploration can be discontinued once one or more dose levels with an acceptable safety profile and satisfactory antitumor activity have been selected for subsequent evaluation.
During the treatment period of the study, three dose levels of CGC729 will be evaluated. Each of the dose levels will evaluate the safety of the CAR-NKT cells.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells
- 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.
Cyclophosphamide + Fludarabine + Infusion of CAR-NKT CellsCombination product
Biological: CD70 CAR-NKT cells. Drug: Cyclophosphamide. Drug: Fludarabine.
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells | Experimental | Lymphodepleting regimen, Cyclophosphamide 250mg/m2 IV on day -5 to -3 and Fludarabine 25mg/m2 IV on days -5 to -3. Followed by infusion of CAR-NKT on day 0.
Potential CGC729 doses:
Dose level 1: 5.0×106 CAR- NKT cells/m2; Dose level 2: 1.5×107 CAR- NKT cells/m2; Dose level 3: 4.5×107 CAR- NKT cells/m2. Receives: Combination Product: Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing DLT
1.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 CGC729 infusion.AE is graded according to CTCAE version 5.0.
Measured: Day 28 after CGC729 infusion
Secondary outcomes (6)
ORR of CD70 CAR-NKT cell dynamics.
Assess Objective response rate(ORR)
Measured: Day 1 through week 52
DCR of CD70 CAR-NKT cell dynamics.
Disease control rate (DCR)
Measured: Day 1 through week 52
The safey of CD70 CAR-NKT cell dynamics
Adverse events (AEs) of CD70 CAR-NKT cell dynamics, Duration and severity of AEs,AE is graded according to CTCAE version 5.0.
Measured: Day 1 through week 52
Cmax of CD70 CAR-NKT cell dynamics.
Peak Plasma Concentration
Measured: Day 1 through week 52
Tmax of CD70 CAR-NKT cell dynamics.
Time to Maximum Plasma Concentration
Measured: Day 1 through week 52
AUC of CD70 CAR-NKT cell dynamics.
Area under the plasma concentration versus time curve
Measured: Day 1 through week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start17 Jul 2023
- Primary completion28 Jan 2025 (estimated)
- Study completion28 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding-Wei Ye, Fudan University
- Investigators
- Jian Zhang, Principal investigator, Fudan UniversityDingwei Ye, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182735
- Sponsor's protocol ID
- CGC729-IIT-01
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- 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 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-NKT in the Treatment of Relapsed or Metastatic Advanced Renal Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT06182735
- Acronym / sponsor ID
- CGC729-IIT-01
- Conditions
- Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 28 Jan 2025 (estimated)
- Study completion
- 28 Jan 2025 (estimated)
- First posted
- 27 Dec 2023 (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 safety, tolerability, PK, and preliminary efficacy of CGC729 with Relapsed or Metastatic advanced renal cell carcinoma.
Condition or disease:Renal Cell Carcinoma Intervention/treatment: Biological: CD70 CAR-NKT cells Phase 1
Detailed description
Dose exploration for this study will be a 3+3 design with a target DLT rate of <1/3. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. Dose exploration can be discontinued once one or more dose levels with an acceptable safety profile and satisfactory antitumor activity have been selected for subsequent evaluation.
During the treatment period of the study, three dose levels of CGC729 will be evaluated. Each of the dose levels will evaluate the safety of the CAR-NKT cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells | Experimental | Combination Product: Cyclophosphamide + Fludarabine + Infusion of CAR-NKT CellsLymphodepleting regimen, Cyclophosphamide 250mg/m2 IV on day -5 to -3 and Fludarabine 25mg/m2 IV on days -5 to -3. Followed by infusion of CAR-NKT on day 0. Potential CGC729 doses: Dose level 1: 5.0×106 CAR- NKT cells/m2; Dose level 2: 1.5×107 CAR- NKT cells/m2; Dose level 3: 4.5×107 CAR- NKT cells/m2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.
- Age 18 to 75 years.
- Patients with advanced clear cell renal cell carcinoma confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
- Archival and/or fresh tumor tissue samples are required.
- At least one measurable lesion at baseline per RECIST version 1.1.
Key exclusion criteria (16 listed)
- Pregnant or lactating female subjects.
- Pregnant or lactating female subjects.
- Known positive test result for human immunodeficiency virus (HIV) oracquired immune deficiency syndrome (AIDS).
- Active infection or uncontrollable infection.
- Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .
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 |
|---|---|---|
| Cyclophosphamide + Fludarabine + Infusion of CAR-NKT CellsBiological: CD70 CAR-NKT cells. Drug: Cyclophosphamide. Drug: Fludarabine. | Combination product | Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells |
Primary outcome
Percentage of Participants Experiencing DLT
Time frame: Day 28 after CGC729 infusion
1.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 CGC729 infusion.AE is graded according to CTCAE version 5.0.
6 secondary outcomes
ORR of CD70 CAR-NKT cell dynamics.
Time frame: Day 1 through week 52
DCR of CD70 CAR-NKT cell dynamics.
Time frame: Day 1 through week 52
The safey of CD70 CAR-NKT cell dynamics
Time frame: Day 1 through week 52
Cmax of CD70 CAR-NKT cell dynamics.
Time frame: Day 1 through week 52
Tmax of CD70 CAR-NKT cell dynamics.
Time frame: Day 1 through week 52
AUC of CD70 CAR-NKT cell dynamics.
Time frame: Day 1 through week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
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. This study is not recruiting at the moment.
Jian Zhang principal investigator
Fudan University
Dingwei Ye principal investigator
Fudan 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 Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells in people with Renal Cell Carcinoma, run by Fudan University 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 9 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang (18017312991, syner2000@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 DLT (time frame: Day 28 after CGC729 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 27 Dec 2023.