CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

  • STATUS
    Recruiting
  • End date
    Feb 24, 2023
  • participants needed
    18
  • sponsor
    Carisma Therapeutics Inc
Updated on 24 March 2022
cancer
breast cancer
bone marrow procedure
HER2
primary cancer
erbb2

Summary

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

Description

A Phase 1, First in Human Study of Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects with HER2 Overexpressing Solid Tumors

Details
Condition HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer, Bladder Cancer, Breast Cancer, Breast Neoplasm, Carcinoma, Ductal, Carcinoma, Hepatocellular, Cancer, Lung Cancer, Non-Small-Cell, Carcinoma, Ovarian Epithelial, Carcinoma, Small Cell, Carcinoma, Squamous, Carcinoma, Transitional Cell, Colorectal Cancer, Esophagogastric Junction Neoplasms, Inflammatory Breast Cancer, Stomach Neoplasms, Malignant Neoplasms, Ovarian Neoplasms, Pancreatic Cancer, HER2-positive Solid Tumors, HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, Prostate Cancer, Head and Neck Cancer, Endometrial Cancer, Lung Cancer, Small Cell
Treatment CT-0508
Clinical Study IdentifierNCT04660929
SponsorCarisma Therapeutics Inc
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion 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

Exclusion 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
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
Other protocol-defined Inclusion/Exclusion may apply
acquisition scan (MUGA)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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