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

CD70-targeted CAR-T therapy is being studied to evaluate its safety and tolerability in patients with advanced or metastatic solid tumors that express the CD70 protein. Researchers aim to find the highest safe dose and understand how this treatment may help patients who have no effective standard options. The study is led by Dr. Weijia Fang.

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

Adults 18 years and older with CD70-positive advanced or metastatic solid tumors that have progressed after standard treatment may be eligible. Both men and women can participate if they have measurable tumors and good organ function. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced or 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 related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID05518253

A Phase I Clinical Study of CD70-targeting CAR-T Therapy in the Treatment of CD70-positive AdvancedMetastatic Solid Tumors

Led by Weijia Fang, MD · Updated on 2025-05-31

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and tolerability of a new CAR-T cell therapy targeting CD70 in patients with advanced or metastatic solid tumors that express CD70. This phase I study aims to find the highest dose patients can safely receive and to recommend a dose for future studies. The trial focuses on patients who have not responded to or cannot tolerate standard treatments and have measurable tumors. The study has two groups receiving CD70-targeted CAR-T cells either by intravenous infusion or intraperitoneal injection. Each group includes three dose levels using a dose-escalation design called 33, with about nine patients planned for each group. Before receiving the CAR-T cells, patients are treated with Fludarabine and Cyclophosphamide. This is an open-label trial without randomization or masking. Participants will be closely monitored for adverse events and dose tolerance during the first 28 days after infusion. Researchers will also assess disease control, objective response rates, treatment duration, and pharmacodynamics over three months. Evaluations include imaging scans, blood tests, and clinical assessments. The total study duration includes safety monitoring, with ongoing follow-up to understand the therapys effects and safety profile.

CONDITIONS

Brief Title

A Clinical Study of 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
Diagnosed with advanced or metastatic solid tumor with positive tumor CD70 expression confirmed by pathology
Disease progression or intolerance after standard treatments like surgery, chemotherapy, or radiotherapy, with no current effective treatment
At least one measurable target lesion according to RECIST 1.1 criteria
ECOG performance status between 0 and 2
Expected survival time of more than 12 weeks
No serious mental disorder
Normal important organ functions including hematopoietic, cardiac, renal, and liver functions
Oxygen saturation greater than 92% without oxygen support
Eligible for apheresis or venous blood collection without contraindications
Agree to use effective contraception methods for 1 year after CAR-T infusion
Provide informed consent and understand the trial procedures

You will not qualify if you...

Prior treatment with anti-CD70 drugs before screening
Active or symptomatic central nervous system or meningeal metastases
Participation in other interventional clinical studies within 3 months or use of certain drugs within specified times before cell reinfusion
Recent chemotherapy, targeted therapy, or high-dose corticosteroids before apheresis
Live attenuated vaccine within 4 weeks before screening
Active or uncontrolled infections requiring systemic treatment
Other malignant tumors within 3 years except treated non-melanoma skin cancers or tumors without active disease
Severe heart conditions including NYHA stage III or IV heart failure, recent myocardial infarction, significant arrhythmia, or severe cardiomyopathy
Active or uncontrolled autoimmune diseases
Positive for certain infections including hepatitis B or C, HIV, syphilis, or cytomegalovirus with abnormal lab values
History of serious venous thromboembolic events requiring ongoing anticoagulation or with lasting symptoms
Poorly controlled hypertension
Pregnancy, breastfeeding, or planning pregnancy within 1 year after CAR-T treatment
Any other condition deemed unsuitable by investigators

Research Team

Weijia Fang, M.D

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