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CAR T-cell Therapy

CAR T Cell Therapy for Pediatric Cancer

Phase 1

Waitlist Available

Led By Navin Pinto, MD

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

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

Must have

Evidence of refractory or recurrent disease

If no apheresis product or usable T cell product is available, at least 3 half-lives or 30 days (whichever is shorter) from time of last dose of anti-tumor directed antibody therapy (including checkpoint inhibitor) at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84 days

Awards & highlights

Study Summary

This trial is testing a new treatment for cancer that uses the patient's own immune cells that have been genetically modified to kill cancer cells. The goal is to find out if it is safe and works well.

Who is the study for?

This trial is for children and young adults up to 26 years old with certain relapsed or refractory solid tumors. They must have a life expectancy of at least 8 weeks, be recovered from previous treatments, have adequate organ function and lab values, and not be pregnant or breastfeeding. Participants over 15 must agree to use effective contraception.Check my eligibility

What is being tested?

The study tests genetically modified T cells targeting B7H3 in non-CNS solid tumors. It has two arms: one receives only B7H3-specific CAR T cells; the other also targets CD19+ B cells. The goals are to assess safety, dose tolerance, cell persistence in the body, and anti-tumor effects.See study design

What are the potential side effects?

Potential side effects include reactions related to immune activation such as cytokine release syndrome (flu-like symptoms), toxicity due to inflammation in organs, and issues that may arise from the destruction of modified T cells by cetuximab or trastuzumab if needed.

Eligibility Criteria

Inclusion Criteria

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

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My condition has not improved or has returned after treatment.

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I haven't received any antibody cancer treatment for the last 30 days or 3 half-lives, whichever is shorter.

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My cancer is not originally from the brain but has been confirmed by tissue examination.

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I have recovered from the major side effects of my previous cancer treatments.

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I can do most activities but need help with some.

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I am 26 years old or younger and consenting to join the study.

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I can undergo apheresis or already have an apheresis product ready for use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assess the safety and tolerability of cellular immunotherapy utilizing ex-vivo expanded autologous T cells genetically modified to express B7H3-specific CAR (Arm A)

Assess the safety and tolerability of cellular immunotherapy utilizing ex-vivo expanded autologous T cells genetically modified to express a bispecific B7H3xCD19 CAR (Arm B)

To assess the dose limiting toxicities (DLTs) and describe the full toxicity profile for each study arm

+6 more

Secondary outcome measures

Describe the relative expansion and persistence of the CAR T cell product and retention of function for B7H3xCD19 bispecific CARs determined by maintenance of B cell aplasia (BCA) with and without pembrolizumab

Determine the duration of in vivo persistence of adoptively transferred T cells in the peripheral blood and compare engraftment between T cell products and treatment arms

Determine the magnitude of in vivo persistence of adoptively transferred T cells in the peripheral blood and compare engraftment between T cell products

+1 more

Other outcome measures

Analyze blood, bone marrow, CSF, normal tissue, and/or tumor tissue for biomarkers of safety and/or anti-tumor activity

Assess the efficacy of infusional cetuximab and/or trastuzumab in ablating transferred T cells and ameliorating acute toxicities in treated participants

Evaluate B7H3 antigen expression in tumor tissue and/or normal tissue if a tissue biopsy, tumor biopsy, or resection is available

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: SCRI-CARB7H3(s)x19 plus pembrolizumabExperimental Treatment2 Interventions

Autologous CD4+ and CD8+ T-cells genetically modified to express a bispecific B7H3xCD19 CAR given in combination with pembrolizumab

Group II: SCRI-CARB7H3(s)x19Experimental Treatment1 Intervention

Autologous CD4+ and CD8+ T-cells genetically modified to a bispecific B7H3xCD19 CAR

Group III: SCRI-CARB7H3(s)Experimental Treatment1 Intervention

Autologous CD4+ and CD8+ T-cells genetically modified to express an B7H3-specific CAR

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

301 Previous Clinical Trials

5,216,909 Total Patients Enrolled

5 Trials studying Germ Cell Tumors

247 Patients Enrolled for Germ Cell Tumors

Navin Pinto, MDPrincipal InvestigatorSeattle Children's Hospital

2 Previous Clinical Trials

86 Total Patients Enrolled

Media Library

B7H3 CAR T Cell Immunotherapy (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04483778 — Phase 1

Germ Cell Tumors Research Study Groups: SCRI-CARB7H3(s)x19 plus pembrolizumab, SCRI-CARB7H3(s), SCRI-CARB7H3(s)x19

Germ Cell Tumors Clinical Trial 2023: B7H3 CAR T Cell Immunotherapy Highlights & Side Effects. Trial Name: NCT04483778 — Phase 1

B7H3 CAR T Cell Immunotherapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04483778 — Phase 1

Frequently Asked Questions

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

What positive effects are hoped to be achieved with this clinical investigation?

"Over the course of 28 days, this clinical trial will seek to identify B7H3-specific CAR's maximum tolerated dose (MTD). Secondary objectives include calculating T cell product persistence in peripheral blood and assessing anti-tumor responses by monitoring changes in tumor burden. Lastly, relative expansion and retention of function for B7H3xCD19 bispecific CARs is determined using measurements of BCA maintenance from presence of CAR T cells in the bloodstream."

Answered by AI

Are there still opportunities available for participation in this clinical trial?

"Confirmed, according to clinicaltrials.gov this trial is currently recruiting participants. The listing was posted on July 13th 2020 and updated as recently as May 2nd 2022. 68 volunteers are needed from a single medical centre for the study to proceed."

Answered by AI

Are elderly individuals eligible for participation in this clinical trial?

"This investigation is open to participants aged 0-26."

Answered by AI

Am I eligible to be involved in this research endeavor?

"To meet the eligibility criteria for this trial, patients must have been formally diagnosed with Wilms tumour and be aged between 0-26 years. 68 individuals are being considered to participate in the clinical study."

Answered by AI

Has the second generation 4-1BBζ B7H3-EGFRt-DHFR been officially sanctioned by the FDA?

"Our evaluation of second generation 4-1BBζ B7H3-EGFRt-DHFR's safety is a 1, as the Phase 1 trial for this drug has only yielded minimal support for its efficacy and protection."

Answered by AI

How many participants have been accepted into this experiment?

"That is correct. According to information found on clinicaltrials.gov, this research project that was inaugurated on July 13th 2020 is accepting participants. 68 volunteers from a single medical centre are needed for the study's successful completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults

Colleen Annesley 2020. "B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04483778.

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