- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03393936
Safety and Efficacy of CCT301 CAR-T in Adult Subjects With Recurrent or Refractory Stage IV Renal Cell Carcinoma
October 19, 2021 updated by: Shanghai PerHum Therapeutics Co., Ltd.
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
66
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200000
- Shanghai Public Health Clinical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CCT301-59
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.
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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.
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Experimental: CCT301-38
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase I Safety (Incidence of adverse events defined as dose-limiting toxicities(DLT)
Time Frame: Up to 28 days from cell infusion
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Incidence of adverse events defined as dose-limiting toxicities (DLT)
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Up to 28 days from cell infusion
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Phase II Objective Response Rate
Time Frame: Up to 9 months from cell infusion
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Objective Response Rate of confirmed complete and partial remission by independent radiology review RECIST (1.1)
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Up to 9 months from cell infusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tongyu Zhu, Shanghai Public Health Clinical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 26, 2018
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
December 25, 2017
First Submitted That Met QC Criteria
January 3, 2018
First Posted (Actual)
January 9, 2018
Study Record Updates
Last Update Posted (Actual)
October 21, 2021
Last Update Submitted That Met QC Criteria
October 19, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCT301-mRCC01; Phase I/II
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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