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

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ClinicalTrials.gov Identifier: NCT04696731

Recruitment Status : Recruiting

First Posted : January 6, 2021

Last Update Posted : March 29, 2022

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Allogene Therapeutics

Tracking Information

First Submitted Date ^ICMJE

January 4, 2021

First Posted Date ^ICMJE

January 6, 2021

Last Update Posted Date

March 29, 2022

Actual Study Start Date ^ICMJE

February 24, 2021

Estimated Primary Completion Date

December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316 [ Time Frame: 28 days ]
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316 [ Time Frame: 33 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Advanced/Metastatic Clear Cell Renal Cell Carcinoma

Intervention ^ICMJE

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
Drug: Cyclophosphamide
Chemotherapy for lymphodepletion

Study Arms ^ICMJE

Experimental: ALLO-647, ALLO-316

Interventions:

Genetic: ALLO-316
Biological: ALLO-647
Drug: Fludarabine
Drug: Cyclophosphamide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Original Estimated Enrollment ^ICMJE

Estimated Study Completion Date ^ICMJE

October 2025

Estimated Primary Completion Date

December 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Allogene

415-604-5696

clinicaltrials@allogene.com

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04696731

Other Study ID Numbers ^ICMJE

ALLO-316-101

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Allogene Therapeutics

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Allogene Therapeutics

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Allogene Therapeutics

Verification Date

March 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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