Chinese Regulatory Agency Clears CT103A for Clinical Studies in Relapsed or Refractory Multiple Myeloma

Chinese Regulatory Agency Clears CT103A for Clinical Studies in Relapsed or Refractory Multiple Myeloma

IASO Biotherapeutics and Innovent Biologics are preparing the launch of a Phase 1b/2 clinical trial in China to evaluate the companies’ novel CAR T-cell product, CT103A, in people with relapsed or refractory multiple myeloma.

The announcement comes after the therapy was granted Investigational New Drug status by the National Medical Products Administration — the Chinese agency for regulating therapies and medical devices.

“This is an important milestone that allows us to continue with CT103A’s clinical development for the treatment of relapsed-refractory multiple myeloma,” Hu Guang, PhD, director of research and development at IASO, said in a news release. “We’re a young company, and this is a big step forward in achieving our objectives to develop and bring to market the most advanced therapies for treating patients more effectively.”

CT103A is a chimeric antigen receptor (CAR) T-cell therapy designed to target and kill malignant cancer cells that carry the BCMA protein. BCMA, or B-cell maturation antigen, is a cell surface protein produced at high levels by several cancer cell types, including multiple myeloma and other B-cell malignancies.

Because CT103A contains a fully-human BCMA antibody, it is expected to reduce the side effects associated with other similar therapies. It also contains other activating factors designed to make it more potent and last longer than other therapies.

In a pilot clinical study, (ChiCTR1800018137), CT103A led to strong anti-cancer responses in patients with relapsed-refractory multiple myeloma, including those who relapsed after receiving prior CAR T-cell therapy.

The most recent findings were discussed at the 17th Annual International Myeloma Workshop in Boston, in the oral presentation “Clinical Responses and Pharmacokinetics of fully human BCMA Targeting CAR T Cell Therapy in Relapsed/Refractory Multiple Myeloma” (Abstract OAB-033).

At the time of the analysis, 18 patients received an infusion of CT103A at one of three doses (one million, three million, or six million cells per kilogram of body weight), after receiving a conditioning chemotherapy regimen of cyclophosphamide plus fludarabine.

These patients had received a median of four prior treatments, and some had relapsed after being treated with a murine (mouse-based) anti-BCMA CAR T-cell therapy.

The CT103A treatment was well-tolerated across all doses, and was effective at the lowest dose tested, where seven of eight evaluable patients (88%) achieved a very good partial response or better.

A total of 17 patients (94%) experienced a common side effect of immunotherapies called cytokine release syndrome (CRS) — where the immune system becomes overactive and potentially damages healthy tissues and cells. This reaction was mostly mild to moderate (grade 1–2) and generally manageable with no neuronal damage.

A severe case was reported in the highest dose group, which was considered as a dose-limiting toxicity event. In patients treated with the lowest dose, one had a serious CRS (grade 3 or worse).

These results show that CT103A has a good safety profile, and could represent a “competitive therapeutic to treat patients with relapse-refractory multiple myeloma,” the researchers wrote.

The upcoming Phase 1b/2 trial will determine the best dose of CT103A to be used in relapsed or refractory myeloma patients. The company anticipates that the therapy will move into a Phase 2 shortly thereafter, with the hope that it may get final approval in 2021.

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Inês holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.

2 comments

  1. Jaime Watkins says:

    My husband has multiple myeloma and we just went through a bone marrow transplant. The transplant did not work, his cancer is back. He is high risk and in stage 3, what could this mean for us.

    • Robert Sullivan says:

      Jaime I don’t know about your husbands situation and I have no medical back ground .. I came down with Multiple Myeloma in 2004 and was treated for 10 mo with thalidomide and Dex. at that point I was taken off the meds as my numbers for light chains etc were good , I was not declared in remission and told I probably had from 3 to 5 years to live as you can see that proved Not to be the case , I have had no further treatment for the MM but go in every 6 mo for blood tests , It is showing the the MM is still there but below the level that would require treatment , I have taken it on myself to make myself as healthy as possible by eating top quality foods , Greek and Asian in particular also for breakfast I eat a mixture of fruits and veg’s , ie apples , pairs . oranges ,radish’s , tomatoes , I do Not eat Potatoe’s -they are a member of the nightshade family- … I also drink tart cherry juice , and take several vit. B,C,D,E …. The Vit D I take 5000 IU daily , the E ..400 IU’s .. I just had my blood test and still in the ok range .. I have ask my oncologist why I am still here .. he does not have a clue … I have no idea if what I am doing actually has any effect and not prescribing that any one follow my example but my thoughts are if it won’t hurt me and could help I am going that route …

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