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CAR T-cell Therapy

Immunotherapy for Solid Cancers (REST Trial)

Phase 1

Waitlist Available

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient or parent/guardian capable of providing informed consent

Aspartate aminotransferase (AST)/ Alanine transaminase (ALT) ≤ 5x the upper limit of normal for age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

REST Trial Summary

This trial is testing whether it is safe to give patients with high-risk solid tumors, who have had no luck with other treatments, a new immunotherapy.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests the safety and potential effectiveness of TAA-CTLs—immune cells trained to target multiple tumor-associated antigens—in patients with tough-to-treat solid tumors. The goal is to see if these specialized T cells can help fight off cancers that haven't responded well to other treatments.See study design

What are the potential side effects?

While specific side effects are not listed here, similar therapies often involve risks such as an immune reaction against normal tissues (autoimmunity), infusion reactions, fatigue, fever, chills, and increased susceptibility to infections.

REST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I (or my guardian) can understand and agree to the study's terms.

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My liver enzymes are within the normal range.

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I have been diagnosed with a high-risk solid tumor.

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My kidney function, measured by creatinine, is within the normal range.

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My cancer did not respond to standard treatment, or it came back.

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My heart functions well, even after full-body radiation.

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I can do most activities but may need help.

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I am between 6 months and 60 years old.

REST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Product-Emergent Adverse Events

Secondary outcome measures

Tumor associated antigen lymphocytes (TAA-CTL) responses

REST Trial Design

2Treatment groups

Experimental Treatment

Group I: Group BExperimental Treatment1 Intervention

Group B includes patients who have undergone conventional (standard) therapy which does not include an allogeneic HSCT. Within group B, a cohort of patients with relapsed or refractory Wilms tumor will be enrolled and receive a lymphodepleting chemotherapy regimen followed by TAA-T. Group B patients (no prior allogeneic HSCT): TAA-T will be infused any time >1 week after completing most recent course of conventional (non-investigational) therapy for their disease. Patients receiving lymphodepletion will be >2 weeks from most recent course of conventional therapy and have nadired and recovered before beginning protocol therapy.

Group II: Group AExperimental Treatment1 Intervention

Group A includes patients who have undergone an allogeneic hematopoietic stem cell transplant (HSCT) as part of their prior therapy. Group A patients (post allogeneic HSCT): TAA-T will be infused any time after neutrophil engraftment post-HSCT or day 30, whichever comes first.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

210 Previous Clinical Trials

207,729 Total Patients Enrolled

Media Library

Tumor associated antigen lymphocytes (TAA-CTL) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02789228 — Phase 1

Solid Tumors Research Study Groups: Group A, Group B

Solid Tumors Clinical Trial 2023: Tumor associated antigen lymphocytes (TAA-CTL) Highlights & Side Effects. Trial Name: NCT02789228 — Phase 1

Tumor associated antigen lymphocytes (TAA-CTL) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02789228 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any participants in this trial aged 45 or above?

"This clinical trial is specifically recruiting patients between the ages of 6 Months and 60. There are 46 studies open to minors, while 422 trials have been made available for seniors over 65 years old."

Answered by AI

Is enrollment currently ongoing for this clinical endeavor?

"As per clinicaltrials.gov, this medical study is not actively enrolling subjects at the moment. First listed in November 2016 and last updated June 2022, though there are numerous other trials actively recruiting 449 patients presently."

Answered by AI

Has the FDA greenlit Tumor associated antigen lymphocytes (TAA-CTL) for medical use?

"Our team has conservatively assigned Tumor associated antigen lymphocytes (TAA-CTL) a safety rating of 1, as this medical trial is currently in the initial phase and lacks sufficient evidence to ensure its efficacy."

Answered by AI

Am I qualified to enroll in this medical experiment?

"28 individuals with solid tumours aged between half a year and 60 years old are recruited for this medical trial. Applicants must meet certain criteria, including having a Karnofsky/Lansky score of at least 50%, have refractory or relapsed disease after conventional treatments, and comply with the recipient procurement inclusion rules."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Immunotherapy of Relapsed and Refractory Solid Tumors with Ex Vivo Expanded Multi-tumor Associated Antigen Specific Cytotoxic T Lymphocytes: A Phase I Study

Hont, Amy B., C. Russell Cruz, Robert Ulrey, Barbara O’Brien, Maja Stanojevic, Anushree Datar, Shuroug Albihani, et al.. 2019. “Immunotherapy of Relapsed and Refractory Solid Tumors with Ex Vivo Expanded Multi-tumor Associated Antigen Specific Cytotoxic T Lymphocytes: A Phase I Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.00177.

clinicaltrials.govStudy

Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors

HMeany 2016. "Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02789228.