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BRIEF TITLE: Adenovirally Transduced Autologous Macrophages Engineered to Contain an Anti-HER2 Chimeric Antigen Receptor in Subjects With 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


  • Org Study ID: 101
  • Secondary ID:
  • NCT ID: NCT04660929
  • NCT Alias:
  • Sponsor: Carisma Therapeutics Inc - Industry
  • Source: 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

Overal Status Start Date Phase Study Type
Recruiting January 2021 Phase 1 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 - Time Frame: 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 - Time Frame: 12 months

Condition:

  • HER2-positive
  • Adenocarcinoma
  • Bile Duct Cancer
  • Biliary Tract Cancer
  • Bladder Cancer
  • Breast Cancer
  • Breast Neoplasm
  • Carcinoma, Ductal
  • Carcinoma, Hepatocellular
  • Cancer
  • Carcinoma, Non-Small-Cell Lung
  • 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

Eligibility

Criteria:
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.

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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: Chief Medical Officer

Phone: 267-491-6422

Email: debora.barton@carismatx.com

Locations

Facility Status Contact
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Not yet recruiting Cheng
919-445-4208
catherine_cheng@med.unc.edu
Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
Recruiting Ciminera
215-220-9678
krista.ciminera@pennmedicine.upenn.edu