Print

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.