Clinical Study of CD70-Targeted Chimeric Antigen Receptor T Lymphocytes (CAR-T) in Advanced CD70-Positive Malignant Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CD70-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CD70-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CD70-positive advanced malignancies were obtained and the recommended dose and infusion schedule.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years, regardless of gender;

• Histologically or cytologically confirmed advanced/metastatic solid tumors (tumors with positive CD70 expression, confirmed histopathological ly with IHC 3+ score);

• Failed or intolerant to standard second-line treatments (at least one of the following: tyrosine kinase inhibitors (TKIs), poly(ADP-ribose) polymerase inhibitors (PARPi), anti-angiogenic therapy; disease progression or inability to tolerate surgery, chemotherapy, radiotherapy, or targeted therapy);

• At least one measurable lesion per RECIST 1.1 criteria, with measurable lesions defined as:

∙ Extranodal lesions with a long axis ≥10mm on CT scan;

‣ Lymph node lesions with a short axis ≥15mm on CT scan;

‣ CT slice thickness ≤5mm.

• ECOG performance status of 0-2 ;

• Expected survival ≥12 weeks;

• No history of severe psychiatric disorders;

• Adequate organ function as defined by the following:

∙ Hematology: White blood cell count \>2.0×10⁹/L, neutrophils \>0.8×10⁹/L, lymphocytes \>0.5×10⁹/L, platelets \>50×10⁹/L, hemoglobin \>90g/L;

‣ Cardiac: Echocardiogram showing left ventricular ejection fraction (LVEF) ≥50%, and ECG with no significant abnormalities;

‣ Renal: Serum creatinine ≤2.0×ULN;

‣ Hepatic: ALT and AST ≤3.0×ULN (may be relaxed to ≤5.0×ULN in cases with liver tumor infiltration); total bilirubin ≤2.0×ULN (may be relaxed to ≤3.0×ULN in cases with Gilbert's syndrome or liver tumor infiltration);

‣ Oxygen saturation ≥92% without supplemental oxygen;

• Ability to undergo single or venous blood collection, with no contraindications to cellular collection;

⁃ Female subjects must agree to use reliable contraception (excluding fertility awareness methods) from the time of informed consent until 1 year after CAR-T cell infusion;

⁃ Subject or authorized guardian agrees to participate in the trial and signs the informed consent form (ICF), indicating understanding of the trial's purpose and procedures and willingness to participate.

Locations
Other Locations
China
The 901 Hospital of Joint Logistics Support Force of People Liberation Army
RECRUITING
Hefei
Contact Information
Primary
Donglai Lv, MD
lvxunhuan@163.com
+8613655600090
Time Frame
Start Date: 2025-09-12
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 90
Treatments
Experimental: Intravenous of CD70-targeted CAR-T
Infusion of CD70-targeted CAR-T cells by dose of 3-10x10\^5 cells/kg
Experimental: Intrapleural infusion of CD70-targeted CAR-T
Infusion of CD70-targeted CAR-T cells by dose of 3-10x10\^5 cells/kg
Experimental: Intraperitoneal infusion of CD70-targeted CAR-T
Infusion of CD70-targeted CAR-T cells by dose of 3-10x10\^5 cells/kg
Sponsors
Leads: Chongqing Precision Biotech Co., Ltd

This content was sourced from clinicaltrials.gov

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