Immunotherapy for Solid Cancers
(REST Trial)
Trial Summary
What is the purpose of this trial?
Patients with high-risk solid tumors, those that are refractory to standard up front therapy or relapse after completion of therapy, have a very poor prognosis despite attempts to induce remission with salvage regimen. Novel therapies are critical for this patient population with high-risk cancer. The ability of tumors to be recognized and lysed by the immune system offers a unique opportunity to aid in tumor eradication by expanding and activating these anti-tumor cells. Through this ability to harness sophisticated and specific immunotherapy, residual or relapsed disease that is resistant to chemotherapy and/or radiotherapy could be eradicated. Prior studies have suggested both safety of expanded specific T cells and efficacy in the setting of melanoma, lymphoma or viral eradication. While this therapy has previously been limited by the versatility of the tumor to down-regulate antigens and evade a single immune-target, the use of multi-antigen specific T cells may permit better and more durable anti-tumor immunity. Thus, the investigators propose to infuse these specific multi-antigen anti-tumor T lymphocytes into patients with high risk solid tumors. This trial will be conducted to demonstrate safety of these cells and generate efficacy and biology data that may be important for future studies that may enhance tumor immunotherapy.
Eligibility Criteria
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
Treatment Details
Interventions
- Tumor associated antigen lymphocytes (TAA-CTL) (CAR T-cell Therapy)