HER2 Clinical Trial | Refer a Patient

NOTE: Information on this webpage is applicable to Healthcare Professionals (HCPs) only.

The CT-0508 Study 101 and CT-0508 in combination with pembrolizumab substudy are sponsored by Carisma Therapeutics. It is a Phase 1, first in human clinical research study to explore the safety and tolerability of adenovirally transduced autologous macrophages engineered to contain an anti-HER2 chimeric antigen receptor in subjects with HER2 overexpression in solid tumors. This study is currently taking place in the USA with 7 study centers currently located in California, North Carolina, Oregon, Pennsylvania, Tennessee, Texas, and Washington.

Primary study objective

Main Study

Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpression in solid tumors. [Time Frame: 14 months]

CT-0508 in Combination with Pembrolizumab Substudy

Assess the safety and tolerability of CT-0508 in combination with pembrolizumab in subjects with HER2 overexpressing solid tumors. [Time Frame: 14 months]

Study Treatment & Rationale

CT-0508 is a cell product comprised of autologous, peripheral blood monocyte-derived, pro inflammatory macrophages, transduced with an adenoviral vector containing an anti-HER2 CAR.

Adoptive T cell–based cellular therapies have led to remarkable advances among patients with hematologic malignancies, but not in those with solid tumors. Among the multiple factors impeding T cell immunotherapy in solid tumors is the inability of T cells, including CAR-T cells, to infiltrate the microenvironment surrounding tumor cells. Macrophages, by contrast, are actively recruited into the tumor microenvironment. While macrophages contain the necessary machinery for phagocytosis and antigen presentation, macrophages in the tumor microenvironment (TME), called tumor-associated macrophages (TAMs), typically demonstrate immunosuppressive rather than antitumor behavior. Thus, macrophages engineered to be proinflammatory may be an ideal vector to administer adoptive cellular therapy in solid tumors.

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Study Overview

Participation in the CT-0508 main study could last about 13 months from the screening visit and is separated into 2 groups. Study design includes the following:

Pre-infusion Period

Both Groups (7 weeks)

This phase consists of screening to confirm participant eligibility with procedures including blood tests, complete physical examination, biopsy, CT/MRI, apheresis, and mobilization.

Infusion Period

Group 1 (Day 1, 3, & 5)

Participants receive CT-0508 3 times, 2 days apart.

Group 2 (Day 1)

Participants receive CT-0508 once.

Post-infusion Period

Group 1 (Day 8 through Week 4)

Group 2 (Day 2 through Week 4)

Subjects will be followed for dose limiting toxicity (DLT) after the subject’s last infusion. A Safety Review Committee (SRC) will convene when the second event of a DLT is observed to assess and decide on the best course of action, which may include pausing enrollment.

Efficacy Follow-up and End of Study Visit

Both Groups (Weeks 8 through 52)

Participants visit the study clinic regularly and will undergo tests and assessments (such as tumor biopsies, physical exams, and blood tests) and answer questions about their health.

CT-0508 in Combination with Pembrolizumab substudy

Participants receive Pembrolizumab in combination with CT-0508 either 1 week after CT-0508 or on Day 1 in combination with CT-0508 and and then every 21 days until the end of the study

Key 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.
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 criteria may apply.