A Clinical Study of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
A Phase I Clinical Study of CD70-targeting CAR-T Therapy in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors
1 other identifier
interventional
36
1 country
1
Brief Summary
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CD70-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2021
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2021
CompletedFirst Submitted
Initial submission to the registry
June 12, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedAugust 18, 2023
August 1, 2023
2 years
June 12, 2022
August 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse events after CD70 CAR-T cells infusion [Safety and Tolerability]
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
28 days
Obtain the maximum tolerated dose of CD70 CAR-T cells[Safety and Tolerability]
Dose-limiting toxicity after cell infusion
28 days
Secondary Outcomes (9)
Disease control rate of CAR-T cell preparations in CD70 positive advanced malignancies [Effectiveness]
3 months
Objective response rate (ORR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]
3 months
Duration of Response (DOR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]
3 months
Overall survival(OS)of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]
2 years
Progress-free survival(PFS) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]
2 years
- +4 more secondary outcomes
Other Outcomes (5)
The correlation between CD70 positive rate and safety
2 years
Correlation between CD70 positive rate and efficacy
2 years
Overall survival(OS)of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]
2 years
- +2 more other outcomes
Study Arms (2)
Intravenous of CD70-targeted CAR-T
EXPERIMENTALInfusion of CD70-targeted CAR-T cells by dose of 1-10x106 cells/kg
intraperitoneal injection of CD70-targeted CAR-T
EXPERIMENTALInfusion of CD70-targeted CAR-T cells by dose of 1-10x106 cells/kg
Interventions
Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
Eligibility Criteria
You may qualify if:
- Age ≥18 years old, male or female;
- Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor CD70 expression (tumor CD70 positive (IHC 3+) confirmed by histology or pathology));
- Failure or intolerance after standard treatment (disease progression or intolerance such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.), and there is currently no effective treatment;
- According to the RECIST version 1.1 standard, at least one target lesion with measurable diameter and evaluable, measurable lesions are defined as: extranodal CT scan long diameter ≥ 10mm, lymph node lesions CT scan short diameter ≥ 15mm, scan slice thickness Not larger than 5mm, and has not received local treatment;
- ECOG 0-2 points;
- The expected survival time is more than 12 weeks;
- No serious mental disorder;
- The function of important organs is basically normal:
- Hematopoietic function: neutrophils\>1.0×109/L, platelets\>75×109/L, hemoglobin\>80g/L;
- Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;
- Renal function: serum creatinine≤2.0×ULN;
- Liver function: ALT and AST ≤2.0×ULN (for patients with liver tumor infiltration, it can be relaxed to ≤3.0×ULN);
- Total bilirubin ≤2.0×ULN (Gilbert syndrome or combined liver tumor infiltration can be relaxed to ≤3.0×ULN);
- Oxygen saturation \> 92% in non-oxygen state.
- Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;
- +2 more criteria
You may not qualify if:
- Received CAR-T therapy or other gene-modified cell therapy prior to screening;
- Received anti-CD70 drug treatment before screening;
- Active/symptomatic central nervous system metastases or meningeal metastases at the time of screening; subjects with brain metastases who have been treated must be confirmed to have no imaging-proven progression ≥4 weeks after the end of treatment before they can be enrolled;
- Received any of the following treatments prior to screening:
- Participated in other interventional clinical studies before screening, including: the last use of unmarketed new drugs is less than 3 months before cell reinfusion, or the last use of marketed drugs is less than 5 half-lives from cell reinfusion;
- Received anti-tumor therapy such as chemotherapy and targeted therapy within 2 weeks or at least 5 half-lives (whichever is shorter) before apheresis;
- Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks prior to apheresis (inhalation or topical is allowed in the absence of active autoimmune disease Use steroids and adrenal corticosteroid replacement at doses greater than 10 mg/day of prednisone);
- Received live attenuated vaccine within 4 weeks before screening;
- Active infection or uncontrollable infection requiring systemic treatment within 1 week before screening;
- Malignant tumors other than the target tumor within 3 years prior to screening, except for the following: malignant tumors that have received radical treatment and no known active disease within ≥ 3 years prior to enrollment; or adequately treated of non-melanoma skin cancers with no evidence of disease;
- Have any of the following heart conditions:
- New York Heart Association (NYHA) stage III or IV congestive heart failure;
- Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
- Clinically significant ventricular arrhythmia, or a history of unexplained syncope (except those caused by vasovagal or dehydration);
- History of severe nonischemic cardiomyopathy.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second People's Hospital of Shandong Province
Jinan, Shandong, 250000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianfeng Bi, M.D
The Second People's Hospital of Shandong Province
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2022
First Posted
June 15, 2022
Study Start
December 31, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
August 18, 2023
Record last verified: 2023-08