GC012F: ASH 2022 Wendy Li First-Line Therapy Newly Diagnosed MM

By Wendy Li, MD

How can GC012F help patients with newly diagnosed multiple myeloma? This is a phase 1 open label single arm study of a BCMA/CD19 Dual-Targeting CAR T cells, FasTCAR-T therapy for first line therapy for transplant eligible high newly diagnosed multiple myeloma.

What is the standard of care for patients with multiple myeloma?  

Yes, compare with the standard of the care. Yeah, I think the very important things to understand that's a current standard of care. Yeah, for newly diagnosed multiple myeloma patients is a 6 to 8 cycles of the triple or quadruple, triplet, quadruple plate treatment.

 For like induction therapy, followed by ASaT and then have to have the long term maintenance treatment. So this treatment together, they call the first line therapy, so  one wide use of triple is RAD,  I think the people call VRD, they're the same.

Okay, which is an dexamethasone,  and as a demonstrated in the study.  The RAD plus the transplant could yield sCR rate is about 47%,  and MRD negativity rate around the 50%.  So with our product GC012F, achieving 88% of sCR and 100% MRD negativity.

And we believe the early clinical data of the GC012F like this study right now, the clinical data has demonstrated the potential substantial improvement over the current available therapies.

Can you tell us about the trial design of the GC012F clinical trial?  

This study is focusing on the high risk and transplant eligible, newly diagnosed multiple myeloma patients,  phase 1 study, single arm.

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What is GC012F?

GC012F is an autologous CAR-T therapy candidate that targets both BCMA and CD19 and is manufactured using Gracell's proprietary FasTCAR next-day manufacturing platform. It is also known as BCMA/CD19 Dual-Targeting FasTCAR-T Cells.

GC012F is a FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T (therapy) product candidate being studied in China for the treatment of multiple myeloma and B-cell non-lymphoma. Hodgkin's GC012F targets CD19 and BCMA at the same time to induce rapid, deep and durable responses (response rate), which may increase effectiveness and minimize relapse in patients with multiple myeloma and B-NHL.

What are the key takeaways from this research and data on GC012F, BCMA/CD19 Dual-Targeting CAR T?  

Yes, since this is a Dual CAR T, Dual-Targeting CAR T. So focusing on BCMA/CD19 dual CART. So it would be very favorable. We got the safety data, our profile with just 25% patient grade 1 to 2 CRS,  in other words 75%, there's no CRS and also no grade 3 CRS or more than grade 3 CRS and no ICANS or any toxicity observed in the clinical trial.

 And also, 100% ORR reached in high risk populations, and the other things actually I'd like to mention about, because 100%, patients with multiple high risk factors, 2 and more, even 5 factors, they have. So we got the 88% sCR, and 100% reached very good PR and even better results.

So the patient continue being followed up, for the deepening and the durable response rate and also we got a 100% MRD in negativity, and since this study is still ongoing, so median DR is not reached.  This GCF012F BCMA/CD19 Dual CAR T Cell therapy shows very, actually, I would say encouraging anti-tumor negativity in transplant eligible, high risk, newly diagnosed multiple myeloma patients.

They really, actually very positive when we talk with all the physicians. They're very exciting and very encouraging information, feedback, and they really hope. When will be your, the product in the market or in the us.  So yeah, that's a, this kind of the question, we really hope this product can be brain brought to the US, as soon as possible.

What are your final thoughts about this study?  

So I really like to mention again, this is a very good and a safe product for the patients and compare with current, the standard of care, treatment or other product in the market right now, we believe we can bring, this is the best in class, the product to the patients for newly diagnosed in the marketing.

Wendy Li, MD - About The Author, Credentials, and Affiliations

Since August 2022, Wendy Li, MD has served as our Chief Medical Officer of Gracell Biotechnologies. She has over 20 years of expertise overseeing all important parts of clinical and medical operations at start-up and major pharmaceutical companies in the United States and China. Her expertise includes conducting early- and late-stage clinical studies for various therapeutic candidates for the treatment of hematological malignancies and solid tumors, as well as supervising over 30 successful INDs, NDAs, and BLAs that resulted in multiple multibillion-dollar blockbuster medications. Prior to joining Gracell, Dr. Li worked as CMO of EXUMA Biotech, where she provided strategic medical and clinical leadership for the development of the company's cell treatment pipeline in the United States and Asia. She has previously held leadership positions in clinical development and medical affairs at Pfizer, Sanofi, Genentech, and Sihuan Pharmaceutical. Dr. Li received his medical degree from Sun Yat-sen University of Medical Sciences.

Reference:

PR Newswire - Gracell Biotechnologies Presents Clinical Data for FasTCAR-T GC012F for High Risk, Newly Diagnosed Multiple Myeloma Demonstrating 100% Overall Response Rate. PR Newswire, December 10, 2022