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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


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


Phase 1, first-in-human, open label study of CAR macrophages in 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

Main Study - Group 1 and Group 2 all HER2 overexpressing solid tumors

Intraperitoneal Substudy - HER2 overexpressing peritoneal disease

89[Zr] radiolabeled CT-0508 Substudy - All HER2 overexpressing solid tumors (Univ of Penn, Abramson Cancer Center only)

CT-0508 Combination with Pembrolizumab Substudy - All HER2 overexpressing solid tumors

  • Overall Status
    Active, not recruiting
  • Start Date
    February 2, 2021
  • Phase
    Phase 1
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • 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


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.
CT-0508 in Combination with Pembrolizumab Substudy Only:
Exclusion Criteria:
* Subjects with severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients

- * Subjects with an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).

- * Subjects who have a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

- * Subjects who have had an allogeneic tissue/solid organ transplant

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Jeanett Wetzel

Role: Study Director

Affiliation: Carisma Therapeutics

Overall Contact

Name: N/A

Phone: N/A

Email: N/A


Facility Status Contact