Genetically Modified T-Cell Therapy in Treating Patients With Advanced ROR1+ Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Refractory Chronic Lymphocytic Leukemia
- Hematopoietic and Lymphoid Cell Neoplasm
- Malignant Solid Neoplasm
- Metastatic Lung Non-Small Cell Carcinoma
- Metastatic Triple-Negative Breast Carcinoma
- Recurrent Acute Lymphoblastic Leukemia
- Recurrent Mantle Cell Lymphoma
- Stage III Lung Non-Small Cell Cancer AJCC v7
- Stage IIIA Lung Non-Small Cell Cancer AJCC v7
- Stage IIIB Lung Non-Small Cell Cancer AJCC v7
- Stage IV Lung Non-Small Cell Cancer AJCC v7
- Unresectable Lung Non-Small Cell Carcinoma
- Stage IV Breast Cancer AJCC v6 and v7
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To evaluate the safety of adoptive T cell therapy using ex vivo expanded autologous cluster of differentiation (CD)8+ and CD4+ ROR1 CAR-T cells for patients with advanced ROR1+ hematologic (Cohort A) and epithelial (Cohort B) malignancies. SECONDARY OBJECTIVES: I. To determine ...
PRIMARY OBJECTIVE: I. To evaluate the safety of adoptive T cell therapy using ex vivo expanded autologous cluster of differentiation (CD)8+ and CD4+ ROR1 CAR-T cells for patients with advanced ROR1+ hematologic (Cohort A) and epithelial (Cohort B) malignancies. SECONDARY OBJECTIVES: I. To determine duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells. II. To determine trafficking of adoptively transferred T cells traffic to the bone marrow or other tumor site and function in vivo. III. To determine preliminary antitumor activity of the adoptive transfer of ROR1 CAR-T cells in patients with measurable tumor burden prior to T cell transfer. OUTLINE: This is a dose escalation study of ROR1 CAR-specific autologous T-lymphocytes. Patients receive chemotherapy comprising fludarabine phosphate and cyclophosphamide as determined by the referring physician in consultation with the protocol principal investigator (PI). Beginning within 36-96 hours after completion of lymphodepleting chemotherapy, patients receive ROR1 CAR-specific autologous T-lymphocytes intravenously (IV) over 20-30 minutes. Patients may receive a second infusion of ROR1 CAR-specific autologous T-lymphocytes with or without additional cytoreductive therapy at the same (for those that received the highest cell dose) or up to the next highest dose level and there is persistent disease, there were no toxicities attributed to the first infusion, and the patient is at least 21 days from the first T cell infusion. After completion of study treatment, patients are followed up for at least 15 years.
Tracking Information
- NCT #
- NCT02706392
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: David Maloney Fred Hutch/University of Washington Cancer Consortium
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