Immunotherapy for Solid Cancers
(REST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new immunotherapy treatment for individuals with high-risk solid tumors that haven't responded to standard treatments or have returned after treatment. The goal is to determine if a special immune cell infusion, called Tumor Associated Antigen Lymphocytes (TAA-CTL), can safely help the body combat these challenging cancers, such as Ewing sarcoma or esophageal carcinoma. Researchers are studying two groups: one includes patients who have undergone a specific type of stem cell transplant, and the other includes those who have not. Suitable candidates have a diagnosed high-risk solid tumor that either didn't respond to regular treatment or has recurred after treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on steroids, the dose must be less than 0.5 mg/kg/day of prednisone (or equivalent). Also, you should not have received certain immunosuppressive treatments like ATG or Campath within 28 days before the cell infusion.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that a type of immune cell called TAA-CTL has been studied for its safety in treating solid tumors. In earlier studies, patients have tolerated these special cells well. Reports suggest they might offer a non-toxic treatment option for tumors that have returned or are difficult to treat.
One study found that TAA-CTLs could safely help patients live longer with these challenging conditions. Patients did not experience severe side effects from this treatment, making it a promising option for those whose tumors do not respond to other treatments.
Overall, while more research is needed, early findings suggest that TAA-CTLs are safe and could be effective for treating high-risk solid tumors.12345Why are researchers excited about this study treatment for solid cancers?
Researchers are excited about tumor-associated antigen lymphocytes (TAA-CTL) because they offer a targeted approach to treating solid cancers. Unlike traditional therapies like chemotherapy and radiation, which attack all rapidly dividing cells, TAA-CTL specifically targets cancer cells by recognizing unique markers on their surface. This precision can potentially reduce side effects and improve effectiveness. Additionally, TAA-CTL can be infused after a patient has undergone either a stem cell transplant or conventional therapy, providing flexibility in treatment plans. This innovative approach represents a significant step forward in cancer immunotherapy.
What evidence suggests that this treatment might be an effective treatment for solid cancers?
Research has shown that a type of immune cell treatment, called TAA-CTL, may effectively treat solid tumors. In previous studies, 73% of patients treated with these cells experienced a halt in cancer growth for at least six months. This indicates that most patients had a pause in cancer progression during this period. Additionally, about 75% of patients with aggressive or recurring cancer achieved some level of disease control after receiving this treatment. In this trial, participants in Group A, who have undergone an allogeneic hematopoietic stem cell transplant, and participants in Group B, who have received conventional therapy, will receive TAA-CTLs. These results suggest that TAA-CTLs could offer new hope for people with difficult-to-treat cancers.24678
Are You a Good Fit for This Trial?
This trial is for people aged 6 months to 60 years with high-risk solid tumors like Ewing sarcoma or adenocarcinoma, who have either not responded to standard treatments or whose cancer has returned. Participants need a minimum level of immune cells and organ function, must not be pregnant or breastfeeding, agree to use contraception if applicable, and cannot have uncontrolled infections or recent immunotherapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TAA-CTL infusions with dose escalation to determine the maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants with stable disease or better may receive additional doses of CTLs at 28-day intervals
What Are the Treatments Tested in This Trial?
Interventions
- Tumor associated antigen lymphocytes (TAA-CTL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's National Research Institute
Lead Sponsor