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

Allogene Therapeutics

Status and phase

Active, not recruiting

Phase 1

Conditions

Advanced/Metastatic Clear Cell Renal Cell Carcinoma

Treatments

Drug: Fludarabine

Biological: ALLO-647

Drug: Cyclophosphamide

Genetic: ALLO-316

Study type

Interventional

Funder types

Industry

Identifiers

NCT04696731

ALLO-316-101

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.