Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by David Oh
Headshot of David Oh
David Oh

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, Renal Cell Carcinoma, 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

  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • City of Hope terminated
    Duarte California 91010 United States
  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCSF

  • David Oh
    I am a physician-scientist focused on developing novel immunotherapies with enhanced activity and reduced toxicity, for patients with solid cancers. Clinically, I see patients in the Cancer Immunotherapy Program where I lead numerous early phase trials, with a particular focus on adoptive cell therapies for solid tumors (CAR-T and TCR).

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