Advanced/Metastatic Clear Cell Renal Cell Carcinoma
Conditions
Keywords
CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-316, ALLO-647, CCRCC, Clear Cell Renal Cell Carcinoma
Brief summary
This is a Phase 1 dose escalation study following a 3+3 study design. The purpose of the TRAVERSE study is to assess the safety, efficacy, and cell kinetics of ALLO-316 in adults with advanced or metastatic clear cell renal cell carcinoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, with or without ALLO-647 to define a Phase 2 dose.
Interventions
GENETICALLO-316
ALLO-316 is an allogeneic CAR T cell therapy targeting CD70
BIOLOGICALALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
DRUGFludarabine
Chemotherapy for lymphodepletion
DRUGCyclophosphamide
Chemotherapy for lymphodepletion
Sponsors
Allogene Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed renal cell carcinoma with a predominant clear cell component. * Must have received a checkpoint inhibitor and a VEGF inhibitor in the advanced and/or metastatic setting. * At least one measurable lesion as defined by RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. * Absence of donor (product)-specific anti-HLA antibodies (DSA). * Adequate hematological, renal, liver, pulmonary, and cardiac functions.
Exclusion criteria
* Central nervous system (CNS) metastatic disease (unless controlled and stable for at least 4 weeks), leptomeningeal disease, or cord compression. * Clinically significant CNS dysfunction. * Any other active malignancy within 3 years prior to enrollment. * Prior treatment with anti-CD70 therapies. * Current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy. * Prior treatment with anti-CD52 monoclonal antibody in the past 12 months. * Patients unwilling to participate in the extended safety monitoring period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316 | 28 days |
| Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316 | 33 days |
Countries
United States
Outcome results
None listed