The CT-0508 study is 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 US with 5 total study locations in California, North Carolina, Pennsylvania, Tennessee, and Texas.
- 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]
- Assess the feasibility of manufacturing CT-0508 by describing the percentage of products passing release criteria. [Time Frame: 12 months]
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 evince 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 participation could last about 13 months from the screening visit and is separated into 2 groups. Study design includes the following:
Both Groups (7 weeks)
- This phase consists of screening to confirm participant eligibility with procedures including biopsy, CT/MRI, leukapheresis, mobilization, and apheresis.
Group 1 (Day 1, 3, & 5)
- Participants receive the study therapy 3 times, 2 days apart.
Group 2 (Day 1)
- Participants receive the study therapy once.
Group 1 (Day 8 through Week 4)
Group 2 (Day 2 through Week 4)
- Subjects will be followed for DLT after the subject’s last infusion. An 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.
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.
- 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
- 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.
For more information, please contact Carisma Therapeutics via email at email@example.com.Send Email
Additional study information can also be found on clinicaltrials.gov/NCT04660929
Use the filters, map, and listing to find the nearest study clinic. You can contact the study clinic using the associated email link or phone number.
Sarah Cannon and HCA Research Institute
250 25th Ave N., Suite 307, Nashville, TN 37203