Data on BCMA/CD19 dual-targeting FasTCAR-T GC012F showed 100% minimal residual disease (MRD) negativity and 82.8% MRD negative stringent complete response (sCR) in a predominantly high-risk relapsed/refractory multiple myeloma (RRMM) population
Data on GC012F for treatment of B-NHL will be presented on
In the single-arm, open label, multicenter investigator-initiated trial (IIT), 29 RRMM patients were enrolled and treated with GC012F, between
As of the
- 93.1% (27/29) overall response rate (ORR), with 89.6% (26/29) of patients achieving a very good partial response (VGPR) or better;
- 82.8% (24/29) of patients achieved MRD- sCR;
- 100.0% (29/29) of treated patients achieved MRD negativity.
In this predominantly high-risk patient population, GC012F demonstrated durable responses:
- Median duration of response (DOR) was 37.0 months (95% CI: 11.0-NR);
- Median progression free survival (PFS) was 38.0 months (95% CI: 11.8-NR);
- Longer PFS was achieved in patients with 12-month sustained MRD negativity;
- 34% (10/29) of patients sustained MRD- sCR for more than 12 months and had an estimated PFS rate of 100% at 36 months.
GC012F continued to show a favorable safety profile:
- No new safety findings in the longer-term follow-up, including no any neurotoxicity;
- No second primary malignancies reported;
- Cytokine release syndrome (CRS) were mostly low grade (Grade 1/2: 79%). Grade 3 CRS was observed in two patients (2/29, 7%) with quick recovery after standard of care treatment. No Grade 4/5 CRS events occurred;
- No neurotoxicity or immune effector cell-associated toxicity (ICANS) of any grade was observed;
"Longer-term results for our evaluation of GC012F in patients with RRMM further demonstrate the potential of our lead candidate," said Dr.
Additional information about the presentation and the 2023 ASCO Annual Meeting is available on the ASCO website.
GC012F is Gracell's FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer and autoimmune disease treatment by driving fast, deep and durable responses with improved safety profile. GC102F is currently being evaluated in investigator-initiated trials in multiple myeloma and B-cell non-Hodgkin's lymphoma (B-NHL), and has demonstrated a consistently strong efficacy and safety profile. In
Introduced in 2017, FasTCAR is Gracell's revolutionary next-day autologous CAR-T cell manufacturing platform. FasTCAR is designed to lead the next generation of therapy for cancer and autoimmune diseases, and improve outcomes for patients by enhancing effect, reducing costs, and enabling more patients to access critical CAR-T treatment. FasTCAR drastically shortens cell production from weeks to overnight, potentially reducing patient wait times and probability for their disease to progress. Furthermore, FasTCAR T-cells appear younger and are more robust than traditional CAR-T cells, making them more proliferative and effective at killing cancer cells. In
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