ACTIVE_NOT_RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, with or without ALLO-647 to define a Phase 2 dose.

Official 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)

Quick Facts

Study Start:2021-02-24

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04696731

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

UCLA Medical Center

Los Angeles, California, 90095

United States

UCSF Medical Center

San Francisco, California, 94143

United States

Yale School of Medicine

New Haven, Connecticut, 06520

United States

Georgetown University Hospital

Washington D.C., District of Columbia, 20007

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

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

Collaborators and Investigators

Sponsor: Allogene Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-24

Study Completion Date2025-12

Study Record Updates

Study Start Date2021-02-24

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

CAR T
Cell Therapy
Allogeneic Cell Therapy
Cellular Immuno-therapy
AlloCAR T
ALLO-316
ALLO-647
CCRCC
Clear Cell Renal Cell Carcinoma

Additional Relevant MeSH Terms

Advanced/Metastatic Clear Cell Renal Cell Carcinoma