U87 CART in Treatment of Advanced Solid Tumor

NCT05605197 | Unknown Phase 1

• 1 other identifier: U87-3
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, open-label, phase 1 study to evaluate the safety and efficacy of U87 CART in treating advanced solid tumor .

Conditions

Pancreatic Cancer; Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse events after U87 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) Dose-limiting toxicity after U87 CAR-T cells infusion.

  28 days post administration of CAR-T-cells

Secondary Outcomes (9)

• Disease control rate (DCR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]

  2 years post CAR T cell infusion

• Objective response rate (ORR) of U87 CAR-T cells treatment in advanced solid tumor. [Effectiveness]

  2 years post CAR T cell infusion

• Duration of Response (DOR) of U87 CAR-T cells treatment in advanced solid tumot[Effectiveness]

  2 years post CAR T cell infusion

• Progress-free survival(PFS) of U87 CAR-T cells treatment in advanced solid tumor[Effectiveness]

  2 years post CAR T cell infusion

• Overall survival(OS) of U87 CAR-T cells treatment in advanced solid tumor [Effectiveness]

  2 years post CAR T cell infusion

Study Arms (1)

U87 CAR-T cells

EXPERIMENTAL

The Patients are enrolled into 2 dose level cohorts in sequence

Drug: U87 CAR-T

Interventions

U87 CAR-T DRUG

Subjects will be pretreated with cyclophosphamide 250\~500 mg/m2( body surface area) for 3 days prior to Intravenous injection of U87, followed by intraartery of U87 14 days later with intravenous IL-2. Researchers can perform intratumoral injection based on their judgment.This study will explore two dose of dose 1 (DL-1): 1×106 (±20%) to dose 2 (DL-2): 1×107 (±20%),each group was enrolled in 3\~6 patients.

U87 CAR-T cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary informed consent is given;
• Age 18 to 75;
• Patients with pathologically confirmed advanced solid tumor who have failed first-line therapy; or patients who are intolerant to first-line standard therapy and voluntarily give up standard therapy;
• Immunohistochemical (IHC) staining of tumor tissue samples from patients was positive for U87 specific antigen (≥ 2 +, and the expression rate was ≥ 20%);
• Expected survival ≥12 weeks;
• Measurable tumor lesions according to RECIST 1.1;
• ECOG performance score 0-1;
• Sufficient venous access for mononuclear cell collection;
• HBc Ab positive, HBsAg negative can be included in the group when the PCR detection of HBV DNA is negative;
• Patients should maintain adequate organ function;
• Dyspnea (CTCAE v5.0) ≤ Grade 1; Blood oxygen saturation\>91% without oxygen inhalation;
• Pregnancy test was negative in women of childbearing age; Both male and female subjects should agree to use effective contraceptives during the treatment period and within the following year;

You may not qualify if:

• Pregnant or lactating women;
• Uncontrolled active infections;
• Active Syphilis, HIV, hepatitis B or hepatitis C infection;
• Congenital immunodeficiency;
• Have serious allergic reaction to any drug to be used in this study;
• Other incurable malignant tumors in the past three years;
• History or presence of clinically relevant CNS pathology such as epilepsy, Cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease;
• Have undergone cardiac angioplasty or stent implantation within 12 months, or have a history of myocardial infarction, unstable angina or other clinically significant heart diseases;
• Subjects requiring anticoagulation or long-term antiplatelet therapy;
• Subjects who have undergone major surgery or significant trauma within four weeks before enrolled in the study.
• Other situations that the investigator thinks are not suitable for participating in this study.

Sponsors & Collaborators

• Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd: lead
• Shanghai 10th People's Hospital: collaborator

Study Sites (1)

China Shanghai 10th People's Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Maoquan Li, doctor

CONTACT

021-66300114*3506; cjr.limaoquan@vip.163.com

Shilong Han, doctor

CONTACT

021-66303247

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: November 4, 2022
• Study Start: October 19, 2022
• Primary Completion: December 31, 2024
• Study Completion: October 8, 2025
• Last Updated: May 28, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)