Genetically Modified T-Cell Therapy in Treating Patients With Advanced ROR1+ Malignancies
This phase I trial studies the side effects and best dose of genetically modified T-cell therapy in treating patients with receptor tyrosine kinase-like orphan receptor 1 positive (ROR1+) chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), stage IV non-small cell lung cancer (NSCLC), or triple negative breast cancer (TNBC) that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Genetically modified therapies, such as ROR1 specific chimeric antigen receptor (CAR) T-cells, are taken from a patient's blood, modified in the laboratory so they specifically may kill cancer cells with a protein called ROR1 on their surfaces, and safely given back to the patient after conventional therapy. The "genetically modified" T-cells have genes added in the laboratory to make them recognize ROR1.
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This describes the study’s primary purpose.
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Checked against the public recordLast updated Aug 31, 2022 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Fred Hutchinson Cancer Center
- Interventions being studied
- Other: Laboratory Biomarker Analysis; Biological: ROR1 CAR-specific Autologous T-Lymphocytes
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- INCLUSION CRITERIA FOR PATIENTS WITH CLL, MCL OR ALL (COHORT A)
- CLL who are beyond first remission and who have failed combination chemoimmunotherapy with regimens containing a purine analogue and anti-CD20 antibody, or who have failed tyrosine kinase or phosphatidylinositol 3 (PI3) kinase inhibitors, or who were not eligible for or declined such therapy; patients with fludarabine refractory disease are eligible
- Mantle cell lymphoma patients who are beyond first remission and previously treated with chemoimmunotherapy; patients who have relapsed following autologous hematopoietic cell transplant (HCT) are eligible
- ALL patients who have relapsed or have residual disease following treatment with curative intent; ALL patients must have ROR1 expressed on \> 90% of the leukemia blasts to be eligible
- Confirmation of diagnosis by internal pathology review of initial or subsequent biopsy or other pathologic material at the Fred Hutchinson Cancer Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA)
- Evidence of ROR1 expression by immunohistochemistry or flow cytometry on any prior or current tumor specimen
- Karnofsky performance status \>= 70%
- Negative pregnancy test for women of childbearing potential; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year
- Fertile male and female patients must be willing to use a contraceptive method before, during, and for at least two months after the T cell infusion
- Ability to understand and provide informed consent INCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B):
- Patients with non-small cell lung cancer that is metastatic or inoperable and who have been treated with at least one line of prior therapy or declined conventional therapy
- Patients with known epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations must have been treated on at least one line of molecularly targeted therapy (e.g., erlotinib, crizotinib)
- Patients must have measurable disease by at least one of the criteria below:
- Extra skeletal disease that can be accurately measured in at least one dimension as \>= 10 mm with conventional computed tomography (CT) techniques as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Skeletal or bone-only disease measurable by fludeoxyglucose F 18 (FDG) positron emission tomography (PET) imaging
- ROR1 expression in \> 20% of the primary tumor or metastasis by immunohistochemistry (IHC)
- Karnofsky performance status of \>= 70%
- Patients must be off chemotherapy for a minimum of 3 weeks prior to start of treatment; targeted therapies must be stopped at least 3 days prior to start of lymphodepletion
- Negative pregnancy test for women of childbearing potential; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year
- Fertile male and female patients must be willing to use a contraceptive method before, during and for at least two months after the T cell infusion
- Ability to understand and provide informed consent INCLUSION CRITERIA FOR TNBC:
- Histologically confirmed diagnosis of metastatic TNBC; i.e. breast cancer that is estrogen receptor (ER) negative (=\< 10%), progesterone receptor (PR) negative (=\< 10%), and human epidermal growth factor receptor 2 (HER2) negative (0 or 1+ by immunohistochemistry or negative for gene amplification by fluorescence in situ hybridization \[FISH\])
- Patients must have measurable disease by at least one of the criteria below:
- Extra skeletal disease that can be accurately measured in at least one dimension as \>= 10 mm with conventional CT techniques as defined by RECIST 1.1
- Skeletal or bone-only disease measurable by FDG PET imaging
- Patients must have received standard adjuvant, neoadjuvant, and/or metastatic chemotherapy per National Comprehensive Cancer Network (NCCN) or institutional practice; no maximum on number of prior systemic treatment regimens
- Patients may receive agents to protect against skeletal related complications such as zoledronic acid or denosumab
- ROR1 expression in \> 20% of the primary tumor or metastasis by IHC
- Karnofsky performance status of \>= 70%
- Patients must be off chemotherapy for a minimum of 3 weeks prior to planned leukapheresis
- Negative pregnancy test for women of childbearing potential; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year
- Fertile male and female patients must be willing to use a contraceptive method before, during and for at least two months after the T cell infusion
- Ability to understand and provide informed consent
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 31, 2022. Always confirm current availability with the study team.