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UnknownPhase 1NCT04660929
Official study title

CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Study summary

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCT-0508 and Pembrolizumab

The study team can explain what participation involves.

Who it may be forHER2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 18, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Carisma Therapeutics Inc

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Carisma Therapeutics Inc
Interventions being studied
Biological: CT-0508; Biological: Pembrolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
HER2→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • HER2-positive recurrent or metastatic solid tumors for which there are no available curative treatment options.
  • Breast cancer and gastric/gastroesophageal junction cancers must have failed approved HER2-targeted agents.
  • Other HER2-positive tumor types must have failed standard of care therapies, while prior therapy with anti-HER2 drugs is not required.
  • Subject must be willing and able to undergo tumor tissue biopsy procedures
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Subject has adequate bone marrow and organ function
Reasons someone may not be able to joinExclusion criteria
  • HIV, active hepatitis B or hepatitis C infection.
  • Diagnosis of immunodeficiency or chronic exposure to systemic corticosteroid therapy or any other form of immunosuppressive therapy
  • Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis. o Subjects with small, asymptomatic CNS metastases that do not require treatment are permitted to enroll.
  • Left ventricular ejection fraction (LVEF) \<50% as determined by ECHO or multiple gated acquisition scan (MUGA) Other protocol-defined Inclusion/Exclusion may apply. CT-0508 in Combination with Pembrolizumab Substudy Only:

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope National Medical CenterDuarte, California
  • UNC Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina
  • OHSU Knight Cancer InstitutePortland, Oregon
  • Abramson Cancer CenterPhiladelphia, Pennsylvania
  • Tennessee Oncology / Sarah Cannon Research InstituteNashville, Tennessee
  • M D Anderson Cancer CenterHouston, Texas
  • Fred Hutchinson Cancer CenterSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 18, 2024. Always confirm current availability with the study team.

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