Solid TumorPhase 1NCT06394622
A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors
A Phase 1 study testing Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells in people with Solid Tumor, 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 efficacy, safety and PK of CGC729 in the treatment of advanced malignant solid tumors. Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- 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
- 12 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2024to 28 Jun 2026
- 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
- Age 18 to 75 years.
- ECOG 0-1 points.
- The expected survival time is more than 3 months.
- Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
- IHC: CD70 positive.
- At least one measurable lesion at baseline per RECIST version 1.1.
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- 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.Prothrombin time (PT) : INR < 1.7.
- Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.
- 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.
Who cannot join
- Use of cell therapy within the previous one month.
- Risk of severe bleeding in esophageal cancer
- 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.
- Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms in the past 6 months.
- Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
- Active hepatitis B, HIV positive and HCV positive
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- Active infection or uncontrollable infection.
- 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.
- Unstable respiratory diseases, including interstitial pneumonia.
- Uncontrolled ascites and pleural effusion
- Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .
- Subjects who are using systemic steroids or steroid inhalers for treatment.
- Pregnant or lactating female subjects.
- Other investigators deem it unsuitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University
Shanghai, Shanghai Municipality
Jian Zhang, 18017312991, Syner2000@163.com
About this study
This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC729 in the treatment of advanced malignant solid tumors.
Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I
Read the detailed description
This was a dose-expansion study, we plan to enroll 6 to 12 patients with CD70-positive advanced malignant solid tumors to CGC729 treatment. The intended enrollment for the evaluation of treatment efficacy and safety was planned to be 3 to 6 patients per tumor type.
We used leukapheresis for cell collection. The lymphodepletion procedure was conducted using a combination of fludarabine and cyclophosphamide.
- Conditions
- Solid Tumor
- Being tested
- Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells
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; 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.
ORR of CD70 CAR-NKT cell dynamics
Assess Objective response rate
Measured: Day 1 through week 56
Secondary outcomes (4)
DCR of CD70 CAR-NKT cell dynamics
Disease control rate
Measured: Day 1 through week 56
DOR of CD70 CAR-NKT cell dynamics
Duration of Response
Measured: Day 1 through week 56
PFS of CD70 CAR-NKT cell dynamics
Progress Free Survival
Measured: Day 1 through week 56
OS of CD70 CAR-NKT cell dynamics
Overall survival
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 posted1 May 2024
- Study start11 Apr 2024
- Primary completion28 Jun 2026 (estimated)
- Study completion28 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
- Investigators
- Jian Zhang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394622
- Sponsor's protocol ID
- CGC729-IIT-02
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2024
- Last updated
- 1 May 2024
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06394622
- Acronym / sponsor ID
- CGC729-IIT-02
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 1 May 2024 (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 CGC729 in the treatment of advanced malignant solid tumors.
Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I
Detailed description
This was a dose-expansion study, we plan to enroll 6 to 12 patients with CD70-positive advanced malignant solid tumors to CGC729 treatment. The intended enrollment for the evaluation of treatment efficacy and safety was planned to be 3 to 6 patients per tumor type.
We used leukapheresis for cell collection. The lymphodepletion procedure was conducted using a combination of fludarabine and cyclophosphamide.
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; |
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 18 to 75 years.
- ECOG 0-1 points.
- The expected survival time is more than 3 months.
- Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
- IHC: CD70 positive.
Key exclusion criteria (14 listed)
- Use of cell therapy within the previous one month.
- Risk of severe bleeding in esophageal cancer
- 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.
- Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms in the past 6 months.
- Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
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
ORR of CD70 CAR-NKT cell dynamics
Time frame: Day 1 through week 56
Assess Objective response rate
4 secondary outcomes
DCR of CD70 CAR-NKT cell dynamics
Time frame: Day 1 through week 56
DOR of CD70 CAR-NKT cell dynamics
Time frame: Day 1 through week 56
PFS of CD70 CAR-NKT cell dynamics
Time frame: Day 1 through week 56
OS of CD70 CAR-NKT cell dynamics
Time frame: Day 1 through week 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jian Zhang 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 Solid Tumor, 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 10 inclusion and 14 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 1 May 2024. 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?
ORR of CD70 CAR-NKT cell dynamics (time frame: Day 1 through week 56). 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 1 May 2024.