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NOT YET RECRUITING
NCT06939270
PHASE1/PHASE2

CD73/AXL Targeted HypoSti.CAR-T Cells in CD73/AXL Positive Advanced/Metastatic Solid Tumors

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of novel autologous hypoxia-activated CAR-T cell therapy targeting CD73 and AXL ( CD73/AXL.HypoSti.CAR-T) will be evaluated in patients with CD73/AXL antigen positive advanced/metastatic solid tumors. In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses Of CD73/AXL.HypoSti.CAR-T cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD73/AXL.HypoSti.CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).

Official title: Phase I/II Clinical Trial of CD73/AXL Targeted HypoSti.CAR-T Cells in Treating Patients With CD73/AXL Positive Advanced/Metastatic Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-05-01

Completion Date

2028-05-01

Last Updated

2025-04-22

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

CD73/AXL.HypoSti.CAR-T cells

Dose escalation: Dose1 (1×10\^6 cells/kg) , Dose 2(3×10\^6 cells/kg) ,Dose 3 (1×10\^7cells/kg); Dose expansion: RP2D.

DRUG

Albumin-Bound Paclitaxel

Administered intravenously at dose of 100-200mg/m2 on day -5 .

DRUG

Cyclophosphamide

Administered intravenously at a total dose of 15-30mg/kg on day -3 and day -2 .

DRUG

Fludarabine

Administered intravenously at dose of 30mg/m2/d on day -3 and day -2.

Locations (1)

Biotherapeutic Department, Chinese PLA General Hospital

Beijing, Beijing Municipality, China