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DRUG:

CT-0508

i
Other names: CT-0508, Ad5f35-transduced anti-HER2 CAR-M, CARMA-0508, HER2 targeted autologous CAR macrophage, CT-0285
Company:
CARISMA Therap
Drug class:
HER2 inhibitor, Macrophage stimulant
Related drugs:
22d
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors (clinicaltrials.gov)
P1, N=48, Active, not recruiting, Carisma Therapeutics Inc | Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2023 --> Dec 2024
Enrollment closed • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 overexpression
|
Keytruda (pembrolizumab) • CT-0508
1year
A mesothelin targeting chimeric antigen receptor macrophage (CAR-M) for solid tumor immunotherapy: pre-clinical development of CT-1119 (AACR 2023)
We have previously developed CT-0508, a chimeric antigen receptor macrophage (CAR-M) targeting HER2 which showed efficacy in a variety of pre-clinical models and is currently in a Phase I clinical trial for patients with HER2+ solid tumors. The presented results demonstrate that CT-1119, an autologous human anti-mesothelin CAR-M, can cause phagocytosis, tumor cell killing, and pro-inflammatory cytokine release in response to stimulation with mesothelin. These results show that CAR-M is a feasible approach for the treatment of mesothelin expressing sold tumors via the potential for induction of a systemic anti-tumor response.
Preclinical • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • MSLN (Mesothelin) • TNFA (Tumor Necrosis Factor-Alpha)
|
HER-2 overexpression • MSLN expression • MSLN overexpression • MSLN positive
|
CT-0508 • CT-1119
over1year
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors (clinicaltrials.gov)
P1, N=48, Recruiting, Carisma Therapeutics Inc | N=18 --> 48 | Trial completion date: Feb 2023 --> Dec 2024 | Trial primary completion date: Feb 2022 --> Jul 2023
Enrollment change • Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 overexpression
|
Keytruda (pembrolizumab) • CT-0508
2years
Chimeric antigen receptor macrophages (CAR-M) sensitize solid tumors to anti-PD1 immunotherapy (AACR 2022)
Moreover, our findings provide rationale for the combination of CAR-M with immune checkpoint inhibitors. The anti-HER2 CAR-M, CT-0508, is under evaluation in a phase I clinical trial for patients with HER2 overexpressing solid tumors.
PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8)
|
HER-2 overexpression • HER-2 negative
|
CT-0508
2years
Pre-clinical development of CAR Monocytes (CAR Mono) for solid tumor immunotherapy (AACR 2022)
Our previously developed human chimeric antigen receptor macrophage (CAR-M) platform has shown potent anti-tumor activity in pre-clinical solid tumor models1, and the anti-HER2 CAR-M CT-0508 is currently being evaluated in a Phase I trial... The CAR-mono platform enables an automated, same-day manufacturing process while maintaining the key characteristics of CAR-M therapy. The use of Ad5f35 for human monocyte transduction primes the cells toward M1 macrophage differentiation and produces a cell population phenotypically and functionally similar to our established CAR-M platform. These data provide strong pre-clinical support to advance the CAR-mono platform into clinical testing.1Klichinsky M, et al.
Preclinical • IO biomarker
|
CD14 (CD14 Molecule) • CSF2 (Colony stimulating factor 2) • IL4 (Interleukin 4)
|
CT-0508
3years
[VIRTUAL] Chimeric Antigen Receptor Macrophages (CAR-M) Induce Anti-Tumor Immunity and Synergize with Immune Checkpoint Inhibitors in Pre-Clinical Solid Tumor Models (ASGCT 2021)
The anti-HER2 CAR-M, CT-0508, is under evaluation in a phase I clinical trial for patients with HER2 overexpressing solid tumors (NCT04660929).1...Nat Biotechnol. 2020;38(8):947-953.
Preclinical • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8)
|
HER-2 overexpression • HER-2 negative • MHC-II expression
|
CT-0508
3years
[VIRTUAL] Chimeric antigen receptor macrophages (CAR-M) induce anti-tumor immunity and synergize with T cell checkpoint inhibitors in pre-clinical solid tumor models (AACR 2021)
Moreover, our findings provide rationale for the combination of CAR-M with immune checkpoint inhibitors. The anti-HER2 CAR-M, CT-0508, is under evaluation in a phase I clinical trial for patients with HER2 overexpressing solid tumors.
Preclinical • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8)
|
HER-2 overexpression • HER-2 negative • MHC-II expression
|
CT-0508
over3years
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors (clinicaltrials.gov)
P1, N=18, Recruiting, Carisma Therapeutics Inc | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 overexpression
|
CT-0508
over3years
Clinical • New P1 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • HER-2 overexpression
|
CT-0508
over3years
[VIRTUAL] CAR macrophages (CAR-M) elicit a systemic anti-tumor immune response and synergize with PD1 blockade in immunocompetent mouse models of HER2+ solid tumors (SITC 2020)
Moreover, our findings provide rationale for the combination of CAR-M with immune checkpoint inhibitors. The anti-HER2 CAR-M CT-0508 will be evaluated in an upcoming Phase I clinical trial.
Preclinical • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8)
|
HER-2 expression
|
CT-0508
over3years
[VIRTUAL] CAR macrophages (CAR-M) elicit a systemic anti-tumor immune response and synergize with PD1 blockade in immunocompetent mouse models of HER2+ solid tumors (SITC 2020)
Moreover, our findings provide rationale for the combination of CAR-M with immune checkpoint inhibitors. The anti-HER2 CAR-M CT-0508 will be evaluated in an upcoming Phase I clinical trial.
Preclinical • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • CD8 (cluster of differentiation 8)
|
HER-2 expression
|
CT-0508