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    DRUG:

    MB-105

    i
    Other names: MB-105, MB-105 PSCA CAR, PSCA(dCH2)BBzeta-CAR T-cell, MB105
    Associations

    News

    Trials
    Company:
    Fortress
    Drug class:
    PSCA-targeted CAR-T immunotherapy
    Related drugs:
    Associations

    News

    Trials
    2ms
    PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=21, Recruiting, City of Hope Medical Center | Trial completion date: Jul 2028 --> Nov 2026 | Trial primary completion date: Aug 2027 --> Nov 2026
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    MB-105
    5ms
    PSCA-CAR T cell therapy in metastatic castration-resistant prostate cancer: a phase 1 trial. (PubMed, Nat Med)
    These results support future clinical studies to optimize dosing and combination strategies to improve durable therapeutic outcomes. ClinicalTrials.gov identifier NCT03873805 .
    P1 data • Journal • CAR T-Cell Therapy • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    MB-105
    7ms
    PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=14, Active, not recruiting, City of Hope Medical Center | Trial completion date: Mar 2024 --> Dec 2024
    Trial completion date • CAR T-Cell Therapy • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    cyclophosphamide • fludarabine IV • MB-105
    7ms
    Human anti-PSCA CAR macrophages possess potent antitumor activity against pancreatic cancer. (PubMed, Cell Stem Cell)
    We optimized the cryopreservation of CAR-iMac progenitors that remain functional upon thawing, providing an off-the-shelf, allogeneic cell product that can be developed into CAR-iMacs. Overall, our preclinical data strongly support the potential clinical translation of this human iPSC-derived platform for solid tumors, including pancreatic cancer.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • PSCA (Prostate Stem Cell Antigen 2)
    |
    MB-105
    8ms
    PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=14, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Mar 2024
    Trial completion date • CAR T-Cell Therapy • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    cyclophosphamide • fludarabine IV • MB-105
    9ms
    PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=21, Recruiting, City of Hope Medical Center | Trial completion date: Nov 2025 --> Jul 2028 | Trial primary completion date: Nov 2025 --> Aug 2027
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    MB-105
    12ms
    PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=21, Recruiting, City of Hope Medical Center | Phase classification: P1b --> P1 | Trial completion date: Feb 2026 --> Nov 2025 | Trial primary completion date: Feb 2026 --> Nov 2025
    Phase classification • Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    MB-105
    over1year
    PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1b, N=21, Recruiting, City of Hope Medical Center | Initiation date: Jul 2023 --> Oct 2023
    Trial initiation date • CAR T-Cell Therapy • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    MB-105
    over1year
    PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, City of Hope Medical Center | Trial primary completion date: Nov 2023 --> Aug 2022
    Trial primary completion date • CAR T-Cell Therapy • Metastases
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    cyclophosphamide • fludarabine IV • MB-105
    over1year
    PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=30 --> 15
    Enrollment closed • Enrollment change • CAR T-Cell Therapy • Metastases
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    cyclophosphamide • fludarabine IV • MB-105
    over1year
    PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1b, N=21, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Initiation date: Sep 2023 --> May 2023
    Enrollment open • Trial initiation date • CAR T-Cell Therapy • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    MB-105
    over1year
    Final results from phase I study of PSCA-targeted chimeric antigen receptor (CAR) T cells in patients with metastatic castration resistant prostate cancer (mCRPC). (ASCO 2023)
    12(86%) had previously been treated with chemotherapy; 9 received two taxanes and 3 docetaxel only...The protocol was amended to reduce the LD dose to 300 mg/m2 cyclophosphamide D1-3... PSCA-CAR T cells have anti-cancer activity in mCRPC with DLT of cystitis. LD was required for greater expansion and activity; lower dose LD improved toxicity without clear negative impact on expansion. Clinical trial information: NCT03873805.
    Clinical • P1 data • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    docetaxel • cyclophosphamide • MB-105
    over1year
    PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1b, N=21, Not yet recruiting, City of Hope Medical Center
    New P1 trial • CAR T-Cell Therapy • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    MB-105
    over1year
    Development of adoptive T-cell therapies to target heterogeneity of mCRPC (AACR 2023)
    Additionally, we are actively developing combinations of PSCA-CAR T-cells with secretable T-cell bispecific antibodies to target NEPC antigens. Our studies encompass the in vitro and in vivo safety and efficacy of CAR T-cells engineered to co-target PrAd and NEPC for the treatment of heterogeneous mCRPC.
    PSCA (Prostate Stem Cell Antigen 2)
    |
    MB-105
    over2years
    PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=33, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    cyclophosphamide • fludarabine IV • MB-105
    almost3years
    Off-the-shelf PSCA-directed chimeric antigen receptor natural killer cell therapy to treat pancreatic cancer. (PubMed, Gastroenterology)
    PSCA CAR_s15 NK cells showed therapeutic efficacy in human metastatic PC models without signs of systematic toxicity, providing a strong rationale to support clinical development.
    Journal • IO biomarker
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    MB-105
    almost3years
    Phase 1 study of PSCA-targeted chimeric antigen receptor (CAR) T cell therapy for metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2022)
    The plan was to begin at a dose of 100 million (M) without lymphodepletion (LD) chemotherapy consisting of fludarabine and cyclophosphamide, then add LD to 100M prior to dose escalation to maximum 600M. PSCA-CAR T cell therapy is feasible in pts with mCRPC with DLT of cystitis, and shows preliminary anti-tumor effect at a dose of 100M plus LD. Dose escalation to 300M may proceed.
    P1 data
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    cyclophosphamide • fludarabine IV • MB-105
    3years
    M2 macrophage-mediated immune suppression of chimeric antigen receptor T cells via PD-L1 signaling in prostate cancer (SITC 2021)
    Results We observed significant hampering of PSCA-CAR T cell activity in vitro with the presence of M2 macrophages, but not M1 macrophages, coinciding with a robust induction of PD-L1 in both tumor cells and macrophages...Conclusions Recently, immune checkpoint (IC) blockade (ICB) has been utilized in combination with chimeric antigen receptor (CAR) T cell therapy, with the notion that induction of immune responses with CAR T cells may instigate checkpoint pathways in immunologically cold tumors that would otherwise not respond to ICB. This study gives insights to a mechanism by which CAR T cells and ICB work in synergy to modulate immune landscape of immunologically cold tumors, and our ongoing studies will continue to elucidate the TME-mediated immunosuppression of CAR T cell therapy.
    CAR T-Cell Therapy • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • PSCA (Prostate Stem Cell Antigen 2)
    |
    PD-L1 expression
    |
    MB-105
    over3years
    PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=33, Recruiting, City of Hope Medical Center | Trial completion date: Feb 2021 --> Dec 2022 | Trial primary completion date: Feb 2021 --> Dec 2022
    Clinical • Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • PSCA (Prostate Stem Cell Antigen 2)
    |
    PSCA Expression
    |
    fludarabine IV • MB-105 • cyclophosphamide intravenous