Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma (TRAVERSE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04696731|
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : March 29, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Advanced/Metastatic Clear Cell Renal Cell Carcinoma||Genetic: ALLO-316 Biological: ALLO-647 Drug: Fludarabine Drug: Cyclophosphamide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 24, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||October 2025|
|Experimental: ALLO-647, ALLO-316||
ALLO-316 is an allogeneic CAR T cell therapy targeting CD70
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Chemotherapy for lymphodepletion
Chemotherapy for lymphodepletion
- 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 ]
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04696731
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|UCLA Medical Center||Recruiting|
|Los Angeles, California, United States, 90095|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|United States, Oregon|
|Providence Portland Medical Center||Recruiting|
|Portland, Oregon, United States, 97213|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Responsible Party:||Allogene Therapeutics|
|Other Study ID Numbers:||
|First Posted:||January 6, 2021 Key Record Dates|
|Last Update Posted:||March 29, 2022|
|Last Verified:||March 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Allogeneic Cell Therapy
Clear Cell Renal Cell Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action