Pan-T Booster Co-expressing MSLN CAR T Cell Therapy in Advanced/Metastatic Solid Tumors

NCT05693844 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-05-10

No results posted yet for this study

Summary

In preclinical study, investigators have demonstrated that the newly developed pan-T booster (harbouring CD40 agonist and one T cell costimulator agonist) co-expressing MSLN CAR T cell possess more powerful antitumor activity than previously reported MSLN-CAR T cells. In this clinical trial, enrolled patients receive an initial dose of pan-T booster co-expressing MSLN CAR T cells at 1×10\^6 cells/kg based on the basic principle of dose escalation design, in order to evaluate the safety, feasibility, pharmacokinetics/pharmacodynamics, and efficacy of pan-T booster co-expressing MSLN CAR T cell in vivo.

Conditions

  • Advanced or Metastatic Solid Tumors

Interventions

BIOLOGICAL

Pan-T booster co-expressing MSLN CAR T cell

Starting Dose: 1×10\^6 cells/kg

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

Sponsors & Collaborators

  • UTC Therapeutics Inc.

    collaborator INDUSTRY
  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Yangbin Zhao, PhD · UTC Therapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05693844 on ClinicalTrials.gov