Clinical Trial

Disease: Renal Cell Carcinoma, RCC, (NCT04696731)

Disease info:

Renal cell cancer (also called kidney cancer or renal cell adenocarcinoma) is a disease in which malignant (cancer) cells are found in the lining of tubules (very small tubes) in the kidney. There are 2 kidneys, one on each side of the backbone, above the waist. Tiny tubules in the kidneys filter and clean the blood. 

Cancer that starts in the ureters or the renal pelvis (the part of the kidney that collects urine and drains it to the ureters) is different from renal cell cancer. 

The prognosis and treatment options depend on the stage of the disease, and the patient's age and general health. After renal cell cancer has been diagnosed, tests are done to find out if cancer cells have spread within the kidney or to other parts of the body. The cancer may come back in the kidney or in other parts of the body after initial treatment.

There are different types of treatment for patients with renal cell cancer. Five types of standard treatment are used:

  • Surgery
  • Radiation therapy
  • Chemotherapy
  • Immunotherapy
  • Targeted therapy

New types of treatment are being tested in clinical trials. Patients can enter clinical trials before, during, or after starting their cancer treatment. Follow-up tests may be needed.

Frequency:
The American Cancer Society estimates about 81,800 new cases of kidney cancer will be diagnosed in the United States in 2023, and approximately 14,890 will die from the disease.
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
Who:

Contact

Allogene Therepeutics, Inc.

Phone: 415-604-5696

Email: clinicaltrials@allogene.com

Sponsor:

Allogene Therapeutics, Inc.

Partners:
Locations:

United States, California

City of Hope, Duarte, California, United States, 91010

UCLA Medical Center, Los Angeles, California, United States, 90095

UCSF Medical Center, San Francisco, California, United States, 94143

 

United States, Connecticut

Yale School of Medicine, New Haven, Connecticut, United States, 06520

 

United States, Columbia

Georgetown University Hospital, Washington, District of Columbia, United States, 20007

 

United States, Florida

Moffitt Cancer Center, Tampa, Florida, United States, 33612

 

United States, Michigan

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

 

United States, New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

 

United States, Oregon

Providence Portland Medical Center, Portland, Oregon, United States, 97213

 

United States, Texas

MD Anderson Cancer Center, Houston, Texas, United States, 77030

 

Study start:
Feb. 24, 2021
Enrollment:
120 participants
Gene editing method:
TALENs
Type of edit:
Gene knock-out, gene knock-in
Gene:
CD52 molecule, T Cell Receptor Alpha Constant (TRAC), anti-CD70 CAR knock-in,
Delivery method:
Lentivirus (LV) and Electroporation - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/NCT04696731
Safety updates:

(07-11-2024) Allogene Therapeutics Announces Positive Phase 1 Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Patients with Advanced Renal Cell Carcinoma at SITC and IKCS

(29-10-2024) Allogene Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ALLO-316, an AlloCAR T™ Investigational Product for Adult Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)

(14-05-2023) Allogene Therapeutics Announces Oral Presentation of Phase 1 Data on ALLO-316 at the American Association of Cancer Research (AACR) Annual Meeting

(17-04-2023) Allogene Therapeutics Presents Interim Phase 1 Data on ALLO-316 in Renal Cell Carcinoma at the American Association of Cancer Research (AACR) Annual Meeting

Other links:

LinkRenal Cell Carcinoma InformationLinkRenal Cell Carcinoma FrequencyLinkExplainer: The Clinical Development PathLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem QasimLinkApplying Innovative Technology to Develop AlloCARSLinkGene-Editing IND and Pre-clinical Update

Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

AlloCAR T therapy uses T cells from healthy donors. These cells are isolated in a manufacturing facility, engineered to express CARs to recognise and destroy cancer cells, and modified via gene editing to limit autoimmune response when given to a patient.

The process for manufacturing Allogenes' investigational off-the-shelf AlloCAR T therapy begins by harvesting healthy, selected, screened and tested T cells from healthy donors. Next, the T cells are engineered to express CARs, which recognise certain cell-surface proteins that are expressed in hematologic or solid tumors (i.e CD70 molecule). The next step in the process involves gene editing to reduce the risk of graft-vs-host disease (GVHD) and allogeneic rejection. A T cell receptor gene is knocked out to avoid GVHD. The CD52 gene is knocked out to render the CAR T product resistant to anti-CD52 antibody treatment. The engineered T cells then undergo a purification step and are ultimately cryopreserved in vials for delivery to patients.

Last updated: Nov. 17, 2024
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