Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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

Official Title

A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 Following ALLO-647 Containing Conditioning Regimen in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Keywords

Advanced/Metastatic Clear Cell Renal Cell Carcinoma CAR T Cell Therapy Allogeneic Cell Therapy Cellular Immuno-therapy AlloCAR T ALLO-316 ALLO-647 CCRCC Clear Cell Renal Cell Carcinoma Carcinoma Carcinoma, Renal Cell Cyclophosphamide Fludarabine ALLO-647, ALLO-316

Eligibility

You can join if…

Open to people ages 18-75

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allogene Therapeutics
ID
NCT04696731
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated