A Clinical Study of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors

ConditionsMetastatic Tumor Advanced Solid Tumor Renal Cell Carcinoma Ovarian Cancer Cervix Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorWeijia Fang, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

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;

Trial design

Design model

Parallel

Treatments tested in this trial

CD70 CAR-T cells
Biological/Vaccine
Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
CD70 CAR-T cells
Biological/Vaccine
Administration method: intraperitoneal injection； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Intravenous of CD70-targeted CAR-TExperimental treatment 1 intervention

Group B: intraperitoneal injection of CD70-targeted CAR-TExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

28 days

Obtain the maximum tolerated dose of CD70 CAR-T cells[Safety and Tolerability]

Dose-limiting toxicity after cell infusion

Time frame

28 days

Secondary outcomes

Disease control rate of CAR-T cell preparations in CD70 positive advanced malignancies [Effectiveness]

Disease control rate: including CR, PR and SD

Time frame

3 months

Objective response rate (ORR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]

Objective response rate includes：CR、PR

Time frame

3 months

Duration of Response (DOR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]

DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause

Time frame

3 months

AUCS of CD70 CAR-T cells [Cell dynamics]

AUCS is defined as the area under the curve in 28 days and 90 days

Time frame

3 months

Other outcomes

The correlation between CD70 positive rate and safety

assessment the correlation between CD70 positive rate and the incidence of CRA and ICANS

Time frame

1 years

Correlation between CD70 positive rate and efficacy

assessment the correlation between CD70 positive rate and the disease control rate，Disease control rate: including CR, PR and SD

Time frame

1 years

Overall survival(OS)of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]

OS will be assessed from the first CD70-CAR-T cell infusion to death from any cause (Assessed by investigators based on IRECIST criteria)

Time frame

1 years

Progress-free survival(PFS) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]

PFS will be assessed from the first CD70-CAR-T cell infusion to death from any cause or the first assessment of progression (Assessed by investigators based on IRECIST criteria)

Time frame

1 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weijia Fang, MD

Lead sponsor

Zhejiang University

Sponsor institution

Chongqing Precision Biotech Co., Ltd

Collaborator

Source ClinicalTrials.gov

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