Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)

Part of paid clinical trials in Duarte, California.

Sponsor
Minerva Biotechnologies Corporation
Study ID
NCT04020575
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells — BIOLOGICAL
    huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells are an autologous T cell product transduced with a proprietary lentiviral vector backbone coding for humanized MNC2-scFv (the targeting head).
  • huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D — BIOLOGICAL
    huMNC2-CAR44 T cells or huMNC2-CAR22 CAR T cells are an autologous T cell product transduced with a proprietary lentiviral vector backbone coding for humanized MNC2-scFv (the targeting head) @ RP2D

Study Details

Phase I/II study of adoptive immunotherapy for advanced MUC1\* positive breast cancer with autologous T cells engineered to express either a chimeric antigen receptor, huMNC2-CAR44 or huMNC2-CAR22, which are specific for a cleaved form of MUC1 (MUC1\*).

Key Dates

Start date
Jan 15, 2020
Status verified
Jun 2023
Primary completion
Jan 31, 2025
Completion
Jan 15, 2035

Study Design

Enrollment
69 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Dose escalation or de-escalation is tested in cohorts of 3 patients each using standard "3+3" dose-finding.
  • Experimental: Luminal
    Dose Expansion - 15 patients will be enrolled with luminal (hormone receptor positive, HER2 negative) metastatic breast cancer.
  • Experimental: HER2+
    Dose Expansion - 15 patients will be enrolled with HER2+ metastatic breast cancer.
  • Experimental: Triple Negative
    Dose Expansion - 15 patients will be enrolled with triple negative metastatic breast cancer.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: Within 35 days after T cell infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-3000
Joanne Mortimer, MD
800-826-4673
Joanne Mortimer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
City of Hope Medical Center· Duarte, CA

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