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ASH 2025: In Vivo CAR-T Produced MRD Negativity in All Study Particpants in Small Clinical Trial

Posted: Dec 22, 2025
ASH 2025: In Vivo CAR-T Produced MRD Negativity in All Study Particpants in Small Clinical Trial image

CAR T-cell therapy has revolutionized the way many people with relapsed and refractory blood cancers, including myeloma, are treated. But CAR-T therapy is expensive, even with health insurance, and it is a time-consuming process. This is because cells need to be collected from the patient, sent to a lab where they are modified, and then returned to the patient for infusion. The cost, delay in production, and availability make CAR-T therapy inaccessible for some people. 

In contrast, in vivo CAR-T therapy engineers the T-cells in a patient’s own body through gene therapy. This type of off-the-shelf CAR-T could change the treatment landscape of multiple myeloma again, expanding access to this potentially curative therapy for more patients. 

At the 2025 ASH Annual Meeting, early results from the inMMyCAR study (NCT07075185) showed that one dose of the investigational off-the-shelf in vivo CAR-T treatment called KLN-1010 produced MRD negativity for all patients enrolled in the clinical trial.

How does an in vivo CAR T-cell therapy treat multiple myeloma?

KLN-1010 is a type of gene therapy. It modifies the patient’s genes using a process called selective transduction. During selective transduction, new genetic information is delivered to a patient’s cells using a virus. KLN-1010 is delivered on a virus called vesicular stomatitis virus. By adding a CD3 protein to the virus, the genetic information is able to enter the T cells.

Once the virus has delivered the genetic material, the T cells can start to find and target BCMA. BCMA is a biomarker that is highly expressed on myeloma cells. After the T cells have been engineered to recognize BCMA, they start targeting and attacking myeloma cells. 

KLN-1010 is given as a single infusion. Lymphodepleting chemotherapy is not needed before treatment with KLN-1010.

About the inMMyCAR study

The phase 1 inMMyCAR study is a first-in-human clinical trial. This means it is the first time KLN-1010 is being given to people after earlier lab and animal studies. This clinical trial is ongoing and still enrolling people with relapsed/refractory multiple myeloma.

Very early results are available for three patients enrolled in the study. The patients are between the ages of 61 and 72 with high-risk cytogenetics. They had three to four prior lines of therapy, but none had previously received anti-BCMA therapy. 

What were the early results of the inMMyCAR study?

Early results of this clinical trial were promising. All three patients experienced minimal residual disease (MRD) negativity one month after treatment. MRD is a small amount of cancer cells still in the body. MRD negativity means that only a very small amount of cancer cells are found. Achieving MRD negativity is a way for researchers to measure how effective a treatment is for multiple myeloma. One patient had follow-up data at 3 months and was still MRD negative. 

All of the patients had a partial response to treatment that deepened over time. All three continue to respond to treatment and have not had disease progression. 

What adverse events or side effects were seen in patients treated with in vivo CAR-T?

All patients experienced adverse events during the inMMyCAR study. Infusion-related reactions were seen in 2 out of 3 patients. The reactions were seen within an hour of the infusion and resolved within 48 hours. Tocilizumab was used to help prevent infusion-related reactions.

Two patients experienced grade 2 (low blood pressure, and low oxygen saturation) cytokine release syndrome (CRS). One patient experienced neutropenia (low neutrophils) and another anemia (low red blood cells). In both cases, it resolved quickly. After one month, none of the patients had any infection-related adverse events. 

What does this mean for patients with relapsed/refractory multiple myeloma?

These results of the inMMyCAR clinical trial are very preliminary, but promising. More research needs to be done to understand if the early response to treatment continues and to monitor the patients for safety. If those studies show that the treatment is effective and safe, it may become available for more patients.

Currently, the only way to receive treatment with KLN-1010 is through the inMMyCAR clinical trial. It is currently enrolling and ongoing. Learn more about how to enroll in this clinical trial at ClinicalTrials.gov

Read this abstract: Minimal residual disease (MRD)-negative outcomes following a novel, in vivo gene therapy generating anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR)-T cells in patients with relapsed and refractory multiple myeloma (RRMM): Preliminary results from inMMyCAR, the first-in-human phase 1 study of KLN-1010

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CAR T-cell therapy has revolutionized the way many people with relapsed and refractory blood cancers, including myeloma, are treated. But CAR-T therapy is expensive, even with health insurance, and it is a time-consuming process. This is because cells need to be collected from the patient, sent to a lab where they are modified, and then returned to the patient for infusion. The cost, delay in production, and availability make CAR-T therapy inaccessible for some people. 

In contrast, in vivo CAR-T therapy engineers the T-cells in a patient’s own body through gene therapy. This type of off-the-shelf CAR-T could change the treatment landscape of multiple myeloma again, expanding access to this potentially curative therapy for more patients. 

At the 2025 ASH Annual Meeting, early results from the inMMyCAR study (NCT07075185) showed that one dose of the investigational off-the-shelf in vivo CAR-T treatment called KLN-1010 produced MRD negativity for all patients enrolled in the clinical trial.

How does an in vivo CAR T-cell therapy treat multiple myeloma?

KLN-1010 is a type of gene therapy. It modifies the patient’s genes using a process called selective transduction. During selective transduction, new genetic information is delivered to a patient’s cells using a virus. KLN-1010 is delivered on a virus called vesicular stomatitis virus. By adding a CD3 protein to the virus, the genetic information is able to enter the T cells.

Once the virus has delivered the genetic material, the T cells can start to find and target BCMA. BCMA is a biomarker that is highly expressed on myeloma cells. After the T cells have been engineered to recognize BCMA, they start targeting and attacking myeloma cells. 

KLN-1010 is given as a single infusion. Lymphodepleting chemotherapy is not needed before treatment with KLN-1010.

About the inMMyCAR study

The phase 1 inMMyCAR study is a first-in-human clinical trial. This means it is the first time KLN-1010 is being given to people after earlier lab and animal studies. This clinical trial is ongoing and still enrolling people with relapsed/refractory multiple myeloma.

Very early results are available for three patients enrolled in the study. The patients are between the ages of 61 and 72 with high-risk cytogenetics. They had three to four prior lines of therapy, but none had previously received anti-BCMA therapy. 

What were the early results of the inMMyCAR study?

Early results of this clinical trial were promising. All three patients experienced minimal residual disease (MRD) negativity one month after treatment. MRD is a small amount of cancer cells still in the body. MRD negativity means that only a very small amount of cancer cells are found. Achieving MRD negativity is a way for researchers to measure how effective a treatment is for multiple myeloma. One patient had follow-up data at 3 months and was still MRD negative. 

All of the patients had a partial response to treatment that deepened over time. All three continue to respond to treatment and have not had disease progression. 

What adverse events or side effects were seen in patients treated with in vivo CAR-T?

All patients experienced adverse events during the inMMyCAR study. Infusion-related reactions were seen in 2 out of 3 patients. The reactions were seen within an hour of the infusion and resolved within 48 hours. Tocilizumab was used to help prevent infusion-related reactions.

Two patients experienced grade 2 (low blood pressure, and low oxygen saturation) cytokine release syndrome (CRS). One patient experienced neutropenia (low neutrophils) and another anemia (low red blood cells). In both cases, it resolved quickly. After one month, none of the patients had any infection-related adverse events. 

What does this mean for patients with relapsed/refractory multiple myeloma?

These results of the inMMyCAR clinical trial are very preliminary, but promising. More research needs to be done to understand if the early response to treatment continues and to monitor the patients for safety. If those studies show that the treatment is effective and safe, it may become available for more patients.

Currently, the only way to receive treatment with KLN-1010 is through the inMMyCAR clinical trial. It is currently enrolling and ongoing. Learn more about how to enroll in this clinical trial at ClinicalTrials.gov

Read this abstract: Minimal residual disease (MRD)-negative outcomes following a novel, in vivo gene therapy generating anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR)-T cells in patients with relapsed and refractory multiple myeloma (RRMM): Preliminary results from inMMyCAR, the first-in-human phase 1 study of KLN-1010

Never miss a multiple myeloma research update

Get the latest research updates, helpful articles, upcoming events, and more, delivered straight to your inbox. Sign up for the HealthTree Foundation’s weekly myeloma newsletter.

Sign Up Now

 

The author Leslie Fannon Zhang

about the author
Leslie Fannon Zhang

Leslie Fannon Zhang is a health and science writer and editor who joined HealthTree in 2025. She is passionate about making information about cancer and cancer care as accessible as possible. Leslie has written for the American Society of Clinical Oncology, the American Cancer Society, and the American Association for the Advancement of Science. 

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