Kidney Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT04696731

Recruitment Status:

Recruiting

Sponsor:

Allogene Therapeutics

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There are 6 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
UCLA Medical Center
Los Angeles California, 90095, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT04696731

Recruitment Status:

Recruiting

Sponsor:


Allogene Therapeutics

How clear is this clinincal trial information?

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