Trial record 1 of 1 for:
CT-0508 | her2
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04660929 |
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Recruitment Status :
Recruiting
First Posted : December 9, 2020
Last Update Posted : February 2, 2022
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Sponsor:
Carisma Therapeutics Inc
Information provided by (Responsible Party):
Carisma Therapeutics Inc
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Brief Summary:
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Biological: CT-0508 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 18 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 2, 2021 |
| Estimated Primary Completion Date : | February 2022 |
| Estimated Study Completion Date : | February 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1 and Group 2
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.
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Biological: CT-0508
anti-HER2 CAR macrophages |
Primary Outcome Measures :
- 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 ]Frequency and severity of adverse events including, but not limited to, estimating frequency and severity of Cytokine Release Syndrome (CRS)
- Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria. [ Time Frame: 12 months ]Percentage of products that pass release criteria among all manufactured products.
Secondary Outcome Measures :
- 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 ]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.
- Estimate progression-free survival (PFS). [ Time Frame: 24 months ]
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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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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
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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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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660929
Contacts
| Contact: Ramona Swaby Vice President, Clinical development, MD | (610) 427-3494 | Ramona.Swaby@carismatx.com |
Locations
| United States, California | |
| City of Hope National Medical Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Yuan Yuan, MD 833-310-2278 yuanyuan@coh.org | |
| United States, North Carolina | |
| UNC Lineberger Comprehensive Cancer Center | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Cheng 919-445-4208 catherine_cheng@med.unc.edu | |
| United States, Pennsylvania | |
| Abramson Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Ciminera 215-220-9678 krista.ciminera@pennmedicine.upenn.edu | |
| United States, Tennessee | |
| Tennessee Oncology / Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: AskSarah 615-329-7274 | |
| Principal Investigator: Melissa Johnson, MD | |
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Angela Alexander 713-792-9137 Aalexand@mdanderson.org | |
Sponsors and Collaborators
Carisma Therapeutics Inc
Investigators
| Study Director: | Ramona Swaby, MD | Carisma Therapeutics |
Publications:
| Responsible Party: | Carisma Therapeutics Inc |
| ClinicalTrials.gov Identifier: | NCT04660929 |
| Other Study ID Numbers: |
101 |
| First Posted: | December 9, 2020 Key Record Dates |
| Last Update Posted: | February 2, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Carisma Therapeutics Inc:
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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 |
Additional relevant MeSH terms:
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Carcinoma Breast Neoplasms Neoplasms Lung Neoplasms Prostatic Neoplasms Stomach Neoplasms Head and Neck Neoplasms Endometrial Neoplasms Biliary Tract Neoplasms Bile Duct Neoplasms Ovarian Neoplasms Carcinoma, Hepatocellular Inflammatory Breast Neoplasms Carcinoma, Squamous Cell Carcinoma, Small Cell |
Carcinoma, Non-Small-Cell Lung Carcinoma, Transitional Cell Small Cell Lung Carcinoma Carcinoma, Ductal Carcinoma, Ovarian Epithelial Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms by Site Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Genital Neoplasms, Male |