Unveiling BCMA/CD19 CAR-T Therapy: Why ORR Reaches 100% in NDMM

At the 2025 American Society of Hematology (ASH) Annual Meeting, DXY Hematology Times, in collaboration with the internationally renowned media platform Audio Journal of Oncology, hosted a special "DXY Sound Research Institute" session. Senior journalist Peter Goodwin from Audio Journal of Oncology invited Professor Du Juan from Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine for an on-site interview regarding her team’s research: "FasTCAR-T (GC012F/AZD0120) targeting both BCMA and CD19 as a first-line treatment for newly diagnosed multiple myeloma (NDMM)."

Journalist Peter Goodwin:

I’m Peter Goodwin, reporting live from the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. With me today is Professor Du Juan from Shanghai, China.

You just presented a CAR-T study called an "off-the-shelf" CAR-T, which is very interesting. Could you share the results of this research?

Professor Du Juan:

Thank you very much. We know that CAR-T therapy has demonstrated significant efficacy in relapsed and refractory multiple myeloma (RRMM).

However, the role of CAR-T therapy in newly diagnosed multiple myeloma (NDMM)—especially in patients with high-risk features and advanced age—remains to be clarified.

Administering CAR-T therapy as an early treatment may help reduce tumor heterogeneity at an early stage, thereby avoiding the development of drug resistance.

For this reason, we conducted two studies on NDMM, both using the dual-target CAR-T therapy GC012F, aiming to evaluate its safety and efficacy in NDMM.

Journalist Peter Goodwin:

Your drug targets B-cell maturation antigen (BCMA) and CD19. What are the advantages of dual-target CAR-T, and what is the significance of this combination?

Professor Du Juan:

As we all know, BCMA is universally expressed on malignant plasma cells and is a well-recognized therapeutic target for multiple myeloma (MM).

CD19 is expressed on most plasma cells and also on progenitor cells, indicating that CD19 may possess stem cell-like characteristics.

Therefore, combined targeting of BCMA and CD19 can achieve rapid and sustained therapeutic responses with controllable safety. This is the reason we integrated these two targets into the CAR-T therapy.

Journalist Peter Goodwin:

You have been dedicated to researching the treatment of NDMM. Could you share why you chose this research direction? What is the basis for NDMM patients to receive the new BCMA/CD19 CAR-T therapy?

Professor Du Juan:

We know that this dual-target CAR-T has shown promising efficacy in RRMM patients, but we hope to advance it to newly diagnosed patients.

In our research, we actually conducted two studies. The first study included transplant-eligible high-risk MM patients, including those with R-ISS Stage II and III, high-risk cytogenetics, and extramedullary disease (EMD).

The other study enrolled transplant-ineligible patients.

There are many reasons why patients may be ineligible for transplantation, such as comorbidities and age factors, but in this study, we focused solely on the elderly patient population.

All patients in the second study were over 70 years old, so this study exclusively included elderly patients.

Journalist Peter Goodwin:

Your research mentions a manufacturing process called FasTCAR-T, the FasTCAR-T platform. Could you explain what kind of technology this is and what potential benefits it may bring?

Professor Du Juan:

We know that the production cycle of conventional CAR-T cells typically takes 4–8 weeks.

FasTCAR-T technology not only allows myeloma patients to receive treatment quickly but also enhances the adaptability of T cells.

Therefore, from these two aspects, I believe FasTCAR-T provides more treatment opportunities for myeloma patients.

Journalist Peter Goodwin:

How does this differ from the so-called "off-the-shelf" CAR-T? Is it a solution that can accelerate the entire process?

Professor Du Juan:

This "off-the-shelf" CAR-T therapy, in terms of technical advantages, can benefit patients.

Journalist Peter Goodwin:

So essentially, this product is readily available and can be prepared for patients within 24 hours. What was the actual situation in the study?

Professor Du Juan:

Yes, in fact, the entire production process can save a significant amount of time.

For CAR-T therapy, it still takes some time from apheresis to the completion of the final product—patients usually need 2 or 3 weeks to receive the finished CAR-T cells.

Journalist Peter Goodwin:

From your research data, we can see that this "off-the-shelf" CAR-T therapy achieves deep, durable remission with a high MRD-negative rate. What are the main research results so far?

Professor Du Juan:

The median follow-up time of this study has reached 36.5 months. We observed an Overall Response Rate (ORR) of 100%, and particularly a stringent Complete Response (sCR) rate as high as 97%.

MRD testing was performed using the Euroflow standard with a sensitivity of 10⁻⁶. A total of 30 patients were enrolled in the study, and we observed that all patients achieved MRD negativity.

Journalist Peter Goodwin:

CAR-T therapy is indeed very promising. This seems to be a step forward, especially in terms of treatment waiting time, and the efficacy also appears to be improved.

Do you think this model is changing the current treatment landscape?

Professor Du Juan:

Yes, I hope so.

Currently, significant milestones have been achieved in cancer treatment, especially in immunotherapy.

We hope that immunotherapy can cure MM. Therefore, I believe the results of this study may change the treatment paradigm for multiple myeloma.

Journalist Peter Goodwin:

However, we have to consider the issues of treatment accessibility and cost. Currently, CAR-T therapy is relatively expensive. What are your thoughts on this?

Professor Du Juan:

Yes, this is also a challenge for patients, as some cannot afford it.

But we still need more CAR-T therapies and more diverse platforms—especially for universal CAR-T and in-vivo CAR-T therapies. I believe this can significantly reduce costs.

Journalist Peter Goodwin:

With FasTCAR-T technology and off-the-shelf CAR-T therapy, can more diverse populations receive treatment?

Professor Du Juan:

Yes, I think so. Because our research results have shown that, especially for NDMM, all patients have very high-quality T-cell quantity and function.

This means more patients will be able to receive FasTCAR-T treatment.

Journalist Peter Goodwin:

Could you briefly summarize your research findings for other physicians? And what does this mean for the treatment of NDMM patients?

Professor Du Juan:

Our research shows that dual-target CAR-T therapy can achieve a deep ORR. This means that for NDMM, CAR-T therapy can serve as a potentially effective treatment option, expanding the range of choices for newly diagnosed patients.

—The above content is for reference only for healthcare professionals in specified clinical contexts.

(Abstract link: https://meetings-api.hematology.org/api/abstract/vmpreview/291409)