What is this trial about?
It is well known that osteosarcoma (OS) treatments have had limited success in helping patients with the disease.
Previous research shows you can ’arm’ T-cells with a special molecule called GD2-specific antibody. GD2 is protein found in nearly all OS cells. CD3 is a glycoprotein in T cells. CD3-specific and GD2-specific antibodies help T-cells identify OS cells and kill them.
GD2 and CD3-specific antibodies are mapped onto T-cells, which are then given back to the patient’s body to kill cancer cells.
In this study, the researchers proposed that the T-cells may have a better chance at killing tumour cells if they are armed with these GD2 and CD-3-specific antibodies. They gave this treatment to patients with OS to see if this is an effective treatment.
How does the treatment work?
The treatment in this study is a type of immunotherapy called GD2BATs. GD2BATs therapy is a type of immunotherapy.
Immunotherapies are drugs that use the body’s immune system to kill cancer cells. In this case, GD2BATs are a type of immune cell that has been armed with antibodies that target GD2 and CD3 markers on cancer cells.
The doctors in this study wanted to see what the maximum dose of this treatment is to be effective in treating cancer.
What happened in the trial?
Patients were all under 30 years of age. 3 out of the 12 patients in this trial had OS.
Immunotherapy treatment as described above was given twice a week alongside G-CSF (Granulocyte-Colony Stimulating Factor). G-CSF is a drug that’s most often prescribed after chemotherapy. White blood cells called neutrophils are often destroyed during chemotherapy, causing a condition called neutropenia. G-CSF helps increase white blood cells that protect you from infection.
Results
- All patients who received treatment had cytokine release syndrome (known as CRS). These are symptoms such as chills, headache and fever. CRS is a normal response to GD2BATs cell therapy where the immune system is responding to treatment.
- 5 of the 9 patients who responded to treatment survived for more than one year after treatment.
- The average survival rate was 18 months after receiving treatment.
- This treatment had a clinical response in those paediatric patients who had not previously responded to treatment.
- It is a safe and potentially effective treatment option for those OS patients who have not responded to previous therapies.
What does this mean for osteosarcoma patients?
It is possible that this treatment could help prolong survival rates in osteosarcoma patients who have not responded to previous treatment. However, the participant numbers were very low which makes it harder to apply the findings widely. Low recruitment numbers are common in rare cancer trials such as OS. Therefore, more phase 2 and 3 clinical trials are needed to further look at GD2BATs therapy at its maximum dose for successful treatment.
References:
- Yankelevich M, Thakur A, Modak S, Chu R, Taub J, Martin A, Schalk DL, Schienshang A, Whitaker S, Rea K, Lee DW, Liu Q, Shields A, Cheung NK, Lum LG. Targeting GD2-positive RefractoryCancer that does not respond to treatment./Resistant Neuroblastoma and Osteosarcoma with Anti- CD3 x Anti-GD2 Bispecific AntibodyPart of the immune system which recognises things that do not belong in the body and sticks to them including cancer cells. Armed T cells. Res Sq [Preprint]. 2023 Nov 9:rs.3.rs-3570311. doi: 10.21203/rs.3.rs-3570311/v1. Update in: J Immunother CancerA disease where cells divide and grow uncontrollably and can spread to other areas of the body.. 2024 Mar 21;12(3):e008744. doi: 10.1136/jitc-2023-008744. PMID: 37986911; PMCID: PMC10659559.