What is CD70-targeted CAR-T studying for advanced or metastatic solid tumors?

CD70-targeted CAR-T is being studied to assess its safety and how well it works in treating advanced or metastatic solid tumors that express the CD70 protein. This research aims to find the right doses and delivery methods to help patients with few other treatment options. The study is sponsored by Chongqing Precision Biotech Co., Ltd.

Who may be eligible for this advanced/metastatic solid tumor clinical trial?

Adults aged 18 years or older with CD70-positive advanced or metastatic solid tumors who have not responded to standard treatments may be eligible. Both men and women can participate, but pregnant or breastfeeding women and those planning pregnancy within a year are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced/metastatic solid tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID06010875

A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive AdvancedMetastatic Solid Tumors

Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-11-08

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CD70-targeted CAR-T cells in treating patients with CD70-positive advanced or metastatic solid tumors. This phase 1, single-center study involves two groups based on the delivery method intravenous infusion and intraperitoneal injection. The study aims to find the recommended doses and infusion patterns for these treatments using a dose-escalation design. Each group undergoes two phases a dose discovery phase with four dose levels using a 33 design to recruit about 12 subjects, followed by a dose expansion phase where one or two dose levels are further tested for safety and efficacy with about 6 subjects per dose group. Before CAR-T cell infusion, patients receive lymphodepletion with fludarabine and cyclophosphamide. The doses range from 1 to 10 million cells per kilogram. During the study, participants will be closely monitored for side effects and treatment responses. Researchers will measure adverse events within 28 days and determine the maximum tolerated dose. Effectiveness outcomes include disease control rate, objective response rate, duration of response, progression-free survival, and overall survival over periods up to two years. The study also evaluates the behavior of CAR-T cells in the body over three months. Participants organ functions, quality of life, and safety will be regularly assessed throughout the trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older, male or female
Confirmed advanced or metastatic solid tumor with positive CD70 expression (IHC 3+) by histology or pathology
Disease progression or intolerance after TKI/PARPi, anti-vascular drug treatment, or no effective standard treatment available
Measurable and evaluable lesions defined by RECIST version 1.1, including MRI lesion size criteria
ECOG performance status of 0 to 2
Expected survival time greater than 12 weeks
No serious mental disorder
Basic normal function of important organs including hematopoietic, cardiac, renal, and liver functions
Oxygen saturation above 92% without oxygen support
Suitable for apheresis or venous blood collection without contraindications
Agreement to use effective contraception for 1 year after CAR-T infusion
Informed consent signed by participant or guardian

You will not qualify if you...

Previous treatment with anti-CD70 drugs
Active or symptomatic central nervous system or meningeal metastases unless stable for at least 4 weeks post-treatment
Participation in other interventional clinical studies with recent use of unmarketed or marketed drugs within specified timelines
Recent chemotherapy, targeted therapy, or systemic corticosteroids above 10 mg/day prednisone equivalent before apheresis
Recent live attenuated vaccine within 4 weeks before screening
Active or uncontrolled infection requiring systemic treatment within 1 week before screening
Other malignant tumors within 3 years except treated non-active cancers
Severe heart diseases including NYHA stage III-IV heart failure, recent myocardial infarction or CABG, significant arrhythmias, or severe cardiomyopathy
Active or uncontrolled autoimmune diseases
Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus above normal ranges
Recent venous thromboembolic events requiring anticoagulation or severe bleeding sequelae
Poorly controlled hypertension above 150/90 mmHg unless controlled with treatment
Pregnancy, breastfeeding, or planning pregnancy within 1 year after CAR-T infusion
Other conditions deemed unsuitable by investigators

Research Team

Fei Li, M.D

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