Renal Cell CarcinomaPhase 1/2NCT03393936
Safety and Efficacy of CCT301 CAR-T in Adult Subjects With Recurrent or Refractory Stage IV Renal Cell Carcinoma
A Phase 1/2 study testing CCT301-38 and CCT301-59 in people with Renal Cell Carcinoma, run by Shanghai PerHum Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This is a two arm, open-label, dose escalation and dose expansion clinical study to evaluate the safety and efficacy of infusion of autologous CCT301-38 or CCT 301-59 T cells in adult subjects with relapsed and refractory stage IV metastatic renal cell carcinoma.Subjects with ROR2 positive biopsy will receive… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- CCT301-38 and CCT301-59
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2018to 30 Jun 2023
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18~70 years old.
- Patients are diagnosed as refractory / recurrent, Stage IV renal cell carcinoma by histological method with FDG PET signal > 3 SUV in measurable metastatic lesion.
- Patients with at least two metastatic lesions, including one measurable metastatic tumor lesion >10 mm measurable by CT.
- Tumor tissues samples confirmed CCT301 target positive IHC. Patient with histological biopsy.
- tumor tissue with greater than or equal to 50% positive staining by IHC method for ROR2 ;
- tumor tissue with greater than or equal to 50% positive staining by IHC method for AXL that is ROR2 negative.
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- Expected survival ≥12 weeks.
- ECOG 0-1
- Adequate organ function as documented by:
- ANC≥1.9X10^9/L
- PLT≥100x10^9/L
- Hb≥9.0g/dL
- rCCR≥50ml/min
- ALT and AST≤2.5ULN; for liver metastasis, ALT and AST ≤5ULN
- Serum TBiL≤3.0mg/dL, TBiL≤2.5ULN
- PT: INR < 1.7 or extended PT to normal value < 4s
- Adequate venous access for venous blood collection, and no other contraindication of blood cell separation
- Patients with willingness to be in this study and able to provide informed consent
- Capable of receiving treatment and follow up, included patients are required to receive treatment in the enrolled centre
- Women of childbearing age are required to take acceptable measures to minimize the possibility of pregnancy during whole session. Women of childbearing age must have negative results of serum or urine tests within 24 hours prior to infusion. Women patients must not be in lactation;
- Immunological detection
Who cannot join
- Pregnant women or women in lactation.
- Active HBV or HCV infection.
- HIV/AIDS infection.
- Active infection
- Previously suffered from diseases or concurrent diseases as follows:
- Patients confirmed as severe autoimmune diseases in long-term (over 2 months) need of systemic immune inhibitors (steroid) or as immune-mediated symptomatic diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (for example, Wegener's granulomatosis)
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- Patients with previous diagnosis as motor neuron disease caused by autoimmunity
- Patients previously suffered from toxic epidermal necrolysis (TEN)
- Patients with any mental diseases including dementia, mental status change that may impinge the understanding and performance of informed consent and related questionnaire
- Patients with severe, uncontrollable diseases judged by investigator that may hinder them receiving this treatment
- Patients with other previously active malignant tumors including basal or squamous skin cancer, superficial bladder cancer, and in situ breast carcinoma within 5 years who had been completely cured without the need of follow-up treatment are not excluded.
- Ongoing treatment using systemic steroid or steroid inhalants.
- Previous treatment used gene/cell therapy products.
- Previous experience of immunotherapies including CIK, DC, DC-CIK, LAK for the treatment of cancer.
- Allergic to immunotherapies or related drugs
- Patients in need of treatment for heart failure with ≥2 NYHA or for poor controlled hypertension.
- Patients with unstable or active peptic ulcer or alimentary tract hemorrhage.
- Patients with previous organ transplantation or ready for organ transplantation.
- Patients in need of anticoagulant therapy treatment (warfarin or heparin)
- Patients judged by investigators as not appropriate for this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 200000
About this study
Official title: A Dose Escalation and Dose Expansion Trial to Assess the Safety, Tolerability and Anti-tumor Activity of Autologous T Cell Modified Chimeric Antigen Receptor (CAR) CCT 301-38 or CCT 301-59 in Patients With Recurrent or Refractory Stage IV Renal Cell Carcinoma
This is a two arm, open-label, dose escalation and dose expansion clinical study to evaluate the safety and efficacy of infusion of autologous CCT301-38 or CCT 301-59 T cells in adult subjects with relapsed and refractory stage IV metastatic renal cell carcinoma.Subjects with ROR2 positive biopsy will receive CCT301-59. Subjects with AXL positive biopsy that are ROR2 negative will receive CCT301-38.
- Conditions
- Renal Cell Carcinoma
- Being tested
- CCT301-38, CCT301-59
- Keywords
- CCT301-38, CCT301-59, stage IV metastatic renal cell carcinoma, AXL, ROR2
- 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.
CCT301-38Biological
Subjects will undergo blood draw to isolate peripheral blood mononuclear cells (PBMCs) for the production of CCT301-38. During CCT301-38 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocyte depletion. After lymphodepletion, subjects will receive one dose treatment with CCT301-38 by intravenous (IV) injection.
CCT301-59Biological
Subjects will undergo blood draw to isolate peripheral blood mononuclear cells (PBMCs) for the production of CCT301-59. During CCT301-59 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocyte depletion. After lymphodepletion, subjects will receive one dose treatment with CCT301-59 by intravenous (IV) injection.
| Study group | Role | What they receive |
|---|---|---|
| CCT301-59 | Experimental | The safety and efficacy of CCT301-59 will be evaluated for subjects with ROR2 positive biopsy in a standard 3+3 dose escalation approach. 3 CAR T dosage will be tested in this study: 1×10^5/kg, 1×10^6/kg, 1×10^7/kg CAR+ T cells. Receives: Biological: CCT301-59 |
| CCT301-38 | Experimental | The safety and efficacy of CCT301-38 will be evaluated for subjects with AXL positive but ROR2 negative biopsy in a standard 3+3 dose escalation approach. 3 CAR T dosage will be tested in this study: 1×10^5/kg, 1×10^6/kg, 1×10^7/kg CAR+ T cells. Receives: Biological: CCT301-38 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I Safety (Incidence of adverse events defined as dose-limiting toxicities(DLT)
Incidence of adverse events defined as dose-limiting toxicities (DLT)
Measured: Up to 28 days from cell infusion
Phase II Objective Response Rate
Objective Response Rate of confirmed complete and partial remission by independent radiology review RECIST (1.1)
Measured: Up to 9 months from cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start26 Mar 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2023
Why it stopped: Adjustment of study strategy
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Subjects with ROR2 positive biopsy will receive CCT301-59. Subjects with AXL positive biopsy that are ROR2 negative will receive CCT301-38.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai PerHum Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center
- Responsible party
- Sponsor
- Investigators
- Tongyu Zhu, Principal investigator, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393936
- Sponsor's protocol ID
- CCT301-mRCC01; Phase I/II
- Status last verified
- Oct 2021
- First submitted
- 25 Dec 2017
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation and Dose Expansion Trial to Assess the Safety, Tolerability and Anti-tumor Activity of Autologous T Cell Modified Chimeric Antigen Receptor (CAR) CCT 301-38 or CCT 301-59 in Patients With Recurrent or Refractory Stage IV Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03393936
- Acronym / sponsor ID
- CCT301-mRCC01; Phase I/II
- Conditions
- Renal Cell Carcinoma
- Keywords
- CCT301-38, CCT301-59, stage IV metastatic renal cell carcinoma, AXL, ROR2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adjustment of study strategy
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Shanghai PerHum Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Jan 2018 (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 two arm, open-label, dose escalation and dose expansion clinical study to evaluate the safety and efficacy of infusion of autologous CCT301-38 or CCT 301-59 T cells in adult subjects with relapsed and refractory stage IV metastatic renal cell carcinoma.Subjects with ROR2 positive biopsy will receive CCT301-59. Subjects with AXL positive biopsy that are ROR2 negative will receive CCT301-38.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects with ROR2 positive biopsy will receive CCT301-59. Subjects with AXL positive biopsy that are ROR2 negative will receive CCT301-38.
| Arm | Type | Receives |
|---|---|---|
| CCT301-59 | Experimental | Biological: CCT301-59The safety and efficacy of CCT301-59 will be evaluated for subjects with ROR2 positive biopsy in a standard 3+3 dose escalation approach. 3 CAR T dosage will be tested in this study: 1×10^5/kg, 1×10^6/kg, 1×10^7/kg CAR+ T cells. |
| CCT301-38 | Experimental | Biological: CCT301-38The safety and efficacy of CCT301-38 will be evaluated for subjects with AXL positive but ROR2 negative biopsy in a standard 3+3 dose escalation approach. 3 CAR T dosage will be tested in this study: 1×10^5/kg, 1×10^6/kg, 1×10^7/kg CAR+ T cells. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Men or women aged 18~70 years old.
- Patients are diagnosed as refractory / recurrent, Stage IV renal cell carcinoma by histological method with FDG PET signal > 3 SUV in measurable metastatic lesion.
- Patients with at least two metastatic lesions, including one measurable metastatic tumor lesion >10 mm measurable by CT.
- Tumor tissues samples confirmed CCT301 target positive IHC. Patient with histological biopsy.
- Expected survival ≥12 weeks.
Key exclusion criteria (20 listed)
- Pregnant women or women in lactation.
- Active HBV or HCV infection.
- HIV/AIDS infection.
- Active infection
- Previously suffered from diseases or concurrent diseases as follows:
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 |
|---|---|---|
| CCT301-38Subjects will undergo blood draw to isolate peripheral blood mononuclear cells (PBMCs) for the production of CCT301-38. During CCT301-38 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocyte depletion. After lymphodepletion, subjects will receive one dose treatment with CCT301-38 by intravenous (IV) injection. | Biological | CCT301-38 |
| CCT301-59Subjects will undergo blood draw to isolate peripheral blood mononuclear cells (PBMCs) for the production of CCT301-59. During CCT301-59 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocyte depletion. After lymphodepletion, subjects will receive one dose treatment with CCT301-59 by intravenous (IV) injection. | Biological | CCT301-59 |
Primary outcome
Phase I Safety (Incidence of adverse events defined as dose-limiting toxicities(DLT)
Time frame: Up to 28 days from cell infusion
Incidence of adverse events defined as dose-limiting toxicities (DLT)
Phase II Objective Response Rate
Time frame: Up to 9 months from cell infusion
Objective Response Rate of confirmed complete and partial remission by independent radiology review RECIST (1.1)
Results and safety
The study was stopped early (reason given: Adjustment of study strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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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.
Tongyu Zhu principal investigator
Shanghai Public Health Clinical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CCT301-38 and CCT301-59 in people with Renal Cell Carcinoma, run by Shanghai PerHum Therapeutics Co., Ltd. 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 21 inclusion and 20 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: stopped early, as of the sponsor's last update on 28 Oct 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Adjustment of study strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I Safety (Incidence of adverse events defined as dose-limiting toxicities(DLT) (time frame: Up to 28 days from cell infusion). The study lists 2 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 28 Oct 2024.