Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Carcinoma

Prostatic Neoplasms

Adenocarcinoma

Neoplasm Metastasis

Stomach Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cholangiocarcinoma

Urinary Bladder Neoplasms

Head and Neck Neoplasms

Carcinoma, Ductal

Carcinoma, Transitional Cell

Carcinoma, Small Cell

Inflammatory Breast Neoplasms

Endometrial Neoplasms

Biliary Tract Neoplasms

Bile Duct Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Non-Small-Cell Lung

Small Cell Lung Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Stomach Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Biliary Tract Diseases

Bile Duct Diseases

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Liver Neoplasms

Liver Diseases

Neoplasms, Squamous Cell

Carcinoma, Bronchogenic

Bronchial Neoplasms

Stomach Cancer

Pancreatic Cancer

Ovarian Cancer

Bile Duct Cancer

Menopause

Biliary Tract Cancer

Inflammatory Breast Cancer

Small Cell Lung Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Pembrolizumab

Immunomodulating Agents

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Both groups will receive the full dose manufactured per patient. Group 1 will undergo intra subject dose escalation of IV administrations of up to 500 million total cells on Day 1, up to 1.5 billion total cells on Day 3, and up to 3.0 billion total cells on Day 5. Group 2 will receive the full dose IV on Day 1 of up to 5 billion cells total.

All cohorts will receive the full dose manufactured per patient. Cohorts 1-3 will undergo intrasubject dose escalations of IP administration as follows:

Cohort 1 up to 500 million total cells on Day 1, up to 1 billion total cells on Day 3 and up to 1.5 billion total cells on Day 5.

Cohort 2 up to 1.5 billion total cells on Day 1, up to 2 billion total cells on Day 3 and any remaining cells on Day 5.

Cohort 3 up to 2.5 billion total cells on Day 1 and up to 2.5 billion total cells on Day 3.

Cohort 4 will 1 dose on Day 1 of up to 5 billion total cells.

89\[Zr\] radiolabeled group will receive a full dose IV on Day 1 of up to 500 million total cells of 89\[Zr\] radiolabeled CT-0508 and non-radiolabeled CT-0508 of up to 4.5 billion total cells (Univ of Penn Abramson Cancer Center only).

All regimen levels will receive the full dose manufactured per patient up to 5 billion total cells. Regimen Levels 1 and 2 will undergo intrasubject dose escalations of IV administration as follows:

Regimen Level 1: up to 500 million total cells on Day 1, up to 1.5 billion total cells on Day 3, and up to 3.0 billion total cells on Day 5 plus pembrolizumab 200 mg q3w starting on Day 8.

Regimen Level 2: up to 500 million total cells on Day 1, up to 1.5 billion total cells on Day 3, and up to 3.0 billion total cells on Day 5 plus pembrolizumab 200 mg q3w starting on Day 1.

Regimen Level 3 will receive the full dose IV on Day 1 of up to 5 billion total cells plus pembrolizumab 200 mg q3w starting on Day 1.

CT-0508

Jeanett Wetzel

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

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

Frequency and severity of adverse events including, but not limited to, estimating frequency and severity of Cytokine Release Syndrome (CRS)

Percentage of products that pass release criteria among all manufactured products.

Proportion of subjects with an objective response (either a complete response \[CR\] or partial response \[PR\]) in subjects who received at least 1 dose of CT-0508 and at least the 8-week tumor evaluation as determined by the investigator using RECIST v1.1.

Defined as the time between the date of first dose and the date of first documented disease progression as determined by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first.

Defined as the time between the date of first dose and the date of first documented disease progression as determined by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first.

Carisma Therapeutics Inc

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors	NCT04660929	HER2-positive Adenocarcinoma Bile Duct Cance... Biliary Tract C... Bladder Cancer Breast Cancer Breast Neoplasm Carcinoma, Duct... Carcinoma, Hepa... Cancer Lung Cancer, No... Carcinoma, Ovar... Carcinoma, Smal... Carcinoma, Squa... Carcinoma, Tran... Colorectal Canc... Esophagogastric... Inflammatory Br... Stomach Neoplas... Malignant Neopl... Ovarian Neoplas... Pancreatic Canc... HER2-positive S... HER2-positive B... HER2-positive G... HER-2 Protein O... HER-2 Gene Ampl... Prostate Cancer Head and Neck C... Endometrial Can... Lung Cancer, Sm...	CT-0508 Pembrolizumab	18 Years -	Carisma Therapeutics Inc
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors	NCT04660929	HER2-positive Adenocarcinoma Bile Duct Cance... Biliary Tract C... Bladder Cancer Breast Cancer Breast Neoplasm Carcinoma, Duct... Carcinoma, Hepa... Cancer Lung Cancer, No... Carcinoma, Ovar... Carcinoma, Smal... Carcinoma, Squa... Carcinoma, Tran... Colorectal Canc... Esophagogastric... Inflammatory Br... Stomach Neoplas... Malignant Neopl... Ovarian Neoplas... Pancreatic Canc... HER2-positive S... HER2-positive B... HER2-positive G... HER-2 Protein O... HER-2 Gene Ampl... Prostate Cancer Head and Neck C... Endometrial Can... Lung Cancer, Sm...	CT-0508 Pembrolizumab	18 Years -	Carisma Therapeutics Inc

Spots Global Cancer Trial Database for esophagogastric junction neoplasms