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

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

Primary Outcome 3 - Measure: Assess the safety and tolerability of CT-0508 in combination with pembrolizumab by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors (CT-0508 and pembrolizumab substudy only)

Primary Outcome 3 - Timeframe: 14 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.
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

OFFICIAL INFORMATION

Name: Ramona Swaby, MD

Role: Study Director

Affiliation: Carisma Therapeutics

Overall Contact

Name: Ramona Swaby, MD

Phone: (610) 427-3494

Email: Ramona.Swaby@carismatx.com

LOCATION