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Brief Title: CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

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

INTRODUCTION

  • Org Study ID: 101
  • Secondary ID: N/A
  • NTC ID: NCT04660929
  • Sponsor: Carisma Therapeutics Inc

BRIEF SUMMARY

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

DETAILED 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

  • Overall Status
    Recruiting
  • Start Date
    February 2, 2021
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors.

Primary Outcome 1 - Timeframe: 14 months

Primary Outcome 2 - Measure: Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria.

Primary Outcome 2 - Timeframe: 12 months

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

ELIGIBILITY

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.
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.
-

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Debora Barton, MD

Role: Study Director

Affiliation: Carisma Therapeutics

Overall Contact

Name: Debora Barton, MD

Phone: 267-491-6422

Email: debora.barton@carismatx.com

LOCATION

Facility Status Contact
Facility: City of Hope National Medical Center
Duarte, California 91010
United States
Status: Recruiting Contact: Contact
Yuan Yuan, MD
833-310-2278
yuanyuan@coh.org
Facility: UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact: Contact
Cheng
919-445-4208
catherine_cheng@med.unc.edu
Facility: Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Ciminera
215-220-9678
krista.ciminera@pennmedicine.upenn.edu