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NCT Number: NCT04696731

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

This is a Phase 1 dose escalation study using a 3+3 study design, followed by a phase 1b expansion study. 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced/Metastatic Clear Cell Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Clear-cell metastatic renal cell carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope, Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Participants unwilling to participate in the extended safety monitoring period.

Treatment and study plan

ALLO-316

Genetic

ALLO-316 is an allogeneic CAR T cell therapy targeting CD70

ALLO-647

Biological

ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

Fludarabine

Drug

Chemotherapy for lymphodepletion

Cyclophosphamide

Drug

Chemotherapy for lymphodepletion

Primary outcomes

  1. Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316

    Time frame: 28 days

  2. Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316

    Time frame: 33 days

Sponsors and collaborators

Lead sponsor

Allogene Therapeutics

Industry

Registry information

Official study title

A Phase 1A/1B Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 With Cyclophosphamide/Fludarabine Lymphodepletion Alone or Including ALLO-647 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)

Acronym: TRAVERSE

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Jan 6, 2021
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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