A PHASE 1B STUDY EVALUATING THE SAFETY AND EFFICACY OF AN ALLOGENEIC CELL THERAPY IN SUBJECTS WITH CLEAR CELL RENAL CELL CARCINOMA (ccRCC)
Grant Award Details
Grant Type:
Grant Number:
CLIN2-15343
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$15,000,000
Status:
Pre-Active
Grant Application Details
Application Title:
A PHASE 1B STUDY EVALUATING THE SAFETY AND EFFICACY OF AN ALLOGENEIC CELL THERAPY IN SUBJECTS WITH CLEAR CELL RENAL CELL CARCINOMA (ccRCC)
Public Abstract:
Therapeutic Candidate or Device
An allogeneic anti-CD70 CAR-T cell product will be evaluated for the treatment of advanced or metastatic clear cell renal cell carcinoma (ccRCC).
Indication
Advanced or metastatic clear cell renal cell carcinoma (ccRCC)
Therapeutic Mechanism
The product is an allogeneic TRAC/CD52-knockout CAR T cell therapy targeting CD70. In this clinical study, the allogeneic product will be evaluated for the treatment of subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC) and will be administered after a lymphodepletion regimen. Binding of the chimeric antigen receptor (CAR) to CD70 expressed on ccRCC tumors triggers the CAR T cells to specifically kill the tumor cells.
Unmet Medical Need
For patients with the most common kidney cancer globally, metastatic RCC, there are no approved treatments after second line TKI/ICI. Allogeneic CAR T cells that target CD70 positive cancer cells shows promising response rates and shorter time to initiation of treatment.
Project Objective
Phase 1b trial completion
Major Proposed Activities
An allogeneic anti-CD70 CAR-T cell product will be evaluated for the treatment of advanced or metastatic clear cell renal cell carcinoma (ccRCC).
Indication
Advanced or metastatic clear cell renal cell carcinoma (ccRCC)
Therapeutic Mechanism
The product is an allogeneic TRAC/CD52-knockout CAR T cell therapy targeting CD70. In this clinical study, the allogeneic product will be evaluated for the treatment of subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC) and will be administered after a lymphodepletion regimen. Binding of the chimeric antigen receptor (CAR) to CD70 expressed on ccRCC tumors triggers the CAR T cells to specifically kill the tumor cells.
Unmet Medical Need
For patients with the most common kidney cancer globally, metastatic RCC, there are no approved treatments after second line TKI/ICI. Allogeneic CAR T cells that target CD70 positive cancer cells shows promising response rates and shorter time to initiation of treatment.
Project Objective
Phase 1b trial completion
Major Proposed Activities
- Manufacture product to supply the proposed trial
- Assess safety, tolerability, and preliminary efficacy of the allogeneic product at Phase 1b expansion cohort dose regimen
- Determine the recommended phase 2 regimen (RP2R)
Statement of Benefit to California:
The company is in a unique position to deliver transformative allogeneic CAR-T treatment to Californians and the world due our understanding of the product, manufacturing capabilities, and proven track record of delivering CAR-T cellular therapy since 2019. We have a state-of-the-art manufacturing facility in California, that is capable of producing life-saving products that will help the people in the state and the world.