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.
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 safety and tolerability of CT-0508 in combination with pembrolizumab in subjects with HER2 overexpressing solid tumors. [Time Frame: 14 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 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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*Do not fill out if you are a patient interested in joining the study. Visit the Study Clinic Locations to email the site closest to you.
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:
Both Groups (7 weeks)
Group 1 (Day 1, 3, & 5)
Group 2 (Day 1)
Group 1 (Day 8 through Week 4)
Group 2 (Day 2 through Week 4)
Both Groups (Weeks 8 through 52)
*Other protocol-defined Inclusion/Exclusion criteria may apply.
For more information, please contact Carisma Therapeutics via email at firstname.lastname@example.org.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.