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A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults with Relapsed and/or Refractory Solid Tumor Malignancies
Cancer Categories
Breast,Lung
Karmanos Trial ID
2022-053
NCT ID
NCT05274451
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I
Principal Investigator
Hirva
Mamdani, M.D.
Lung Cancer Screening, Oncology - Medical
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Objective:
Primary Objectives:
To evaluate the safety and tolerability of LYL797 in patients with relapsed/refractory TNBC and NSCLC
To determine the recommended Phase 2 dose (RP2D) of LYL797
Secondary Objectives:
To evaluate the anti-tumor activity of LYL797
To evaluate the pharmacokinetics (PK) (eg, expansion and persistence) in peripheral blood (PB) samples of LYL797
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
≥ 18 years of age at time of informed consent
Histologically confirmed TNBC or NSCLC that is relapsed or refractory, metastatic or locally advanced and unresectable that is ROR1+ by central laboratory immunohistochemistry (IHC)
Measurable disease including a target lesion and an additional lesion for biopsy
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ and marrow function
Women of childbearing potential must have a negative pregnancy test at screening
All participants must agree to practice highly effective methods of contraception
Exclusion Criteria:
Prior treatment with any adoptive T-cell therapy or anti-ROR1 therapy
Prior solid organ transplantation
Active, untreated brain metastasis or leptomeningeal disease; stable, treated brain involvement by disease is allowed
Untreated or active infection at the time of screening or leukapheresis
HIV-positive, HTLV-1-positive, active acute or chronic HBV or HCV, or active tuberculosis
Impaired cardiac function or clinically significant cardiac disease
Uncontrolled pleural or pericardial effusion
Systemic corticosteroids or other immunosuppressive medications within 14 days of leukapheresis
Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or Factor Xa inhibitors
Pregnant or lactating/nursing women
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Breast; Lung
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
CAR-T
Drugs
LYL797
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