Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Purpose

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, and ALLO-647 to define a Phase 2 dose.

Condition

  • Advanced/Metastatic Clear Cell Renal Cell Carcinoma

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ALLO-647, ALLO-316
  • Genetic: ALLO-316
    ALLO-316 is an allogeneic CAR T cell therapy targeting CD70
  • Biological: ALLO-647
    ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion

Recruiting Locations

Georgetown University Hospital
Washington, District of Columbia 20007

More Details

Status
Recruiting
Sponsor
Allogene Therapeutics

Study Contact

Allogene
415-604-5696
clinicaltrials@allogene.com