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

Advanced/Metastatic Clear Cell Renal Cell Carcinoma Clinical Trial

— TRAVERSE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696731
• Other study ID #: ALLO-316-101
• Status: Recruiting
• Phase: Phase 1
• Start date: February 24, 2021
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: Allogene Therapeutics
• Contact: Allogene
• Phone: 415-604-5696
• Email: clinicaltrials[@]allogene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced/Metastatic Clear Cell Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell

Intervention

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
• Cyclophosphamide
Chemotherapy for lymphodepletion

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California
United States	MD Anderson Cancer Center	Houston	Texas
United States	UCLA Medical Center	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Providence Portland Medical Center	Portland	Oregon
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allogene Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316		28 days
Primary	Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316		33 days