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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

Must not have

Patients with uncontrolled infections

Current evidence of GVHD > grade 2 or chronic GVHD manifestations: bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any infections that are currently uncontrolled.

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I have severe graft-versus-host disease symptoms.

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I haven't had experimental immune treatments in the last 28 days.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Product-Emergent Adverse Events

Secondary study objectives

Tumor associated antigen lymphocytes (TAA-CTL) responses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 11Eligibility criteria met