Description:
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid
tumors.
Title
- Brief Title: CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
101
- NCT ID:
NCT04660929
Conditions
- 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
Interventions
Drug | Synonyms | Arms |
---|
CT-0508 | | Group 1 and Group 2 |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
Group 1 and Group 2 | Experimental | 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. | |
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.
-
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
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. |
Time Frame: | 14 months |
Safety Issue: | |
Description: | Frequency and severity of adverse events including, but not limited to, estimating frequency and severity of Cytokine Release Syndrome (CRS) |
Secondary Outcome Measures
Measure: | Estimate the objective response rate (ORR), according to RECIST v1.1, of at least 1 dose of CT-0508 among subjects with HER2 overexpressing solid tumors. |
Time Frame: | 24 months |
Safety Issue: | |
Description: | 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. |
Measure: | Estimate progression-free survival (PFS). |
Time Frame: | 24 months |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Carisma Therapeutics Inc |
Trial Keywords
- HER2-positive solid tumors
- Phase 1
- cell therapy
- CAR-macrophage
- immunotherapy
- advanced cancer
- post menopausal
- premenopausal
- metastatic cancer
- Prostate Cancer
- Head and Neck Cancer
- Lung Cancer, Small Cell
- Endometrial Cancer
- Lung Cancer, Non-Small Cell
Last Updated
June 1, 2021