Afamitresgene Autoleucel for Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have received certain treatments like cytotoxic chemotherapy, tyrosine kinase inhibitors, immune therapy, or corticosteroids before participating. It's best to discuss your current medications with the trial team.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who have received certain treatments like cytotoxic chemotherapy, tyrosine kinase inhibitors, and immune therapies before joining. It's best to discuss your specific medications with the trial team.
What safety data is available for Afamitresgene Autoleucel treatment in sarcoma?
Afamitresgene autoleucel (afami-cel) has been evaluated in a phase 1 trial for safety in patients with MAGE-A4+ solid tumors, including synovial sarcoma. All patients experienced Grade ≥3 hematologic toxicities, and 55% experienced cytokine release syndrome, mostly Grade ≤2. The treatment showed an acceptable benefit-risk profile, with early and durable responses, especially in metastatic synovial sarcoma. The trial's small size limits conclusions, but results support further testing.12345
Is afamitresgene autoleucel safe for humans?
In a phase 1 trial, afamitresgene autoleucel showed a manageable safety profile, with all patients experiencing some blood-related side effects and over half experiencing cytokine release syndrome (a condition where the immune system releases too many proteins into the blood too quickly). Despite these side effects, the treatment was considered to have an acceptable balance of benefits and risks, especially for synovial sarcoma patients.12345
Is the treatment afamitresgene autoleucel a promising treatment for sarcoma?
How is the treatment afamitresgene autoleucel unique for sarcoma?
Afamitresgene autoleucel is a unique treatment for sarcoma because it uses genetically engineered T-cells to specifically target and attack cancer cells expressing the MAGE-A4 antigen, which is not a standard approach for sarcoma. This therapy has shown promising results, especially in synovial sarcoma, with a high disease control rate and manageable side effects.12346
What data supports the idea that Afamitresgene Autoleucel for Sarcoma is an effective treatment?
The available research shows that Afamitresgene Autoleucel, also known as ADP-A2M4, is effective in treating synovial sarcoma, a type of cancer. In a phase 1 trial, 44% of patients with synovial sarcoma showed a positive response to the treatment, meaning their tumors shrank. Additionally, the treatment had a disease control rate of around 90% for synovial sarcoma, indicating that it was able to stop the cancer from getting worse in most patients. These results suggest that Afamitresgene Autoleucel is a promising treatment for this type of cancer.12347
What data supports the effectiveness of the treatment afamitresgene autoleucel for sarcoma?
Research shows that afamitresgene autoleucel, a treatment using engineered T-cells to target a specific cancer protein, shrank tumors in various cancers, with the best results in synovial sarcoma, achieving a disease control rate of about 90% and a partial response rate of 44% in a small trial.12347
Who Is on the Research Team?
Dejka Araujo, MD
Principal Investigator
MD Anderson Cancer Center; Houston TX 77030
Are You a Good Fit for This Trial?
This trial is for people aged 16-75 with advanced synovial sarcoma or myxoid/round cell liposarcoma, who've had certain chemotherapies. They must have measurable disease, be HLA-A*02 positive without the HLA-A*02:05 allele, and show MAGE-A4 expression. Exclusions include autoimmune diseases, other active cancers, significant heart disease, uncontrolled illnesses, infections like HIV or hepatitis B/C, pregnancy/breastfeeding and allergies to study drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive T-cell infusion and are monitored for response and adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term safety and survival outcomes
What Are the Treatments Tested in This Trial?
Interventions
- afamitresgene autoleucel
afamitresgene autoleucel is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adaptimmune
Lead Sponsor