How it is administered

Obecabtagene autoleucel is administered as an intravenous (IV) infusion. It is a personalized therapy made from your own T cells, which are collected from your blood through a process called leukapheresis. The cells are then genetically modified and expanded in a laboratory before being returned to your treatment center.

The medication is supplied in patient-specific infusion bags and is given as a split dose on Day 1 and Day 10 (±2 days), depending on your disease burden. Before receiving the infusion, you will receive a chemotherapy regimen (fludarabine and cyclophosphamide) to prepare your body for the treatment. Premedication with acetaminophen is also recommended to reduce the risk of infusion reactions.

How it works

Obecabtagene autoleucel is a type of CAR T-cell therapy designed to treat certain blood cancers. It works by using your own immune cells (T cells), which are collected and then genetically modified in the lab to express a chimeric antigen receptor (CAR) that specifically targets CD19, a protein found on the surface of B cells, including cancerous B cells in acute lymphoblastic leukemia (ALL).

Once infused back into your body, these modified T cells seek out and bind to CD19-expressing cells. This binding activates the T cells, leading to the destruction of the cancerous B cells. The therapy also includes co-stimulatory domains (4-1BB and CD3-zeta) that help the T cells multiply and persist in your body, enhancing their ability to fight the cancer over time. After treatment, a period of low B cell counts (B cell aplasia) is expected as a sign of the therapy working.

Who Should take it

Obecabtagene autoleucel is indicated for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This means it is intended for patients whose disease has come back after previous treatments or has not responded to standard therapies.

It is especially considered for those who have failed multiple lines of therapy, have relapsed after a short remission, or have relapsed after a stem cell transplant. Your healthcare team will determine if this therapy is suitable for you based on your medical history, current health status, and previous treatments.

Who should not take it

There are no absolute contraindications listed for obecabtagene autoleucel, but it should not be administered to patients with clinically significant active systemic infections, as severe infections can worsen with this therapy.

Patients with active hepatitis B, hepatitis C, or HIV should not receive this treatment, as there is no experience with manufacturing the product for these populations. The safety and efficacy in pediatric patients have not been established, and it is not recommended for use during pregnancy due to potential risks to the fetus. Discuss with your doctor if you are pregnant, planning to become pregnant, or have any active infections.

Commonly used with

Obecabtagene autoleucel is used in combination with a lymphodepleting chemotherapy regimen (fludarabine and cyclophosphamide) given prior to the CAR T-cell infusion. This chemotherapy helps prepare your body to receive the modified T cells and improves their effectiveness.

Supportive medications such as acetaminophen (for premedication) and tocilizumab (to manage cytokine release syndrome) are also commonly used during treatment.

Commonly tested with

In clinical studies, obecabtagene autoleucel has been tested in patients who have previously received other therapies for ALL, including blinatumomab and inotuzumab ozogamicin, as well as those who have undergone stem cell transplantation. The therapy is given after lymphodepleting chemotherapy (fludarabine and cyclophosphamide), and supportive care medications are used as needed to manage side effects.