second generation 4-1BBζ EGFR806-EGFRt for Wilms Tumor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Wilms Tumor+22 More
second generation 4-1BBζ EGFR806-EGFRt - Biological
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing genetically-modified T cells to treat solid tumors in children and young adults. The goal is to evaluate safety and feasibility, and to determine if the cells can kill tumors.

Eligible Conditions
  • Wilms Tumor
  • Solid Tumor Pediatric
  • Malignant Peripheral Nerve Sheath Tumour (MPNST)
  • Neuroblastoma
  • Retinoblastoma
  • Desmoplastic Small Round Cell Tumor
  • Soft Tissue Sarcoma (STS)
  • Rhabdoid Tumor
  • Ewing Sarcoma
  • Carcinoma
  • Clear Cell Sarcoma of Soft Tissue
  • Hepatoblastoma
  • Germ Cell Tumors
  • Synovial Sarcoma
  • Osteosarcoma
  • Rhabdomyosarcoma

Treatment Effectiveness

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: 84 days

28 Days
Establish the safety, defined by adverse events, of EGFR806-specific CAR T cell infusions (Arm A), and of dual transduced EGFR806xCD19 CAR T cell infusions (Arm B)
The number of successfully manufactured EGFR806 and EGFR806xCD19 CAR T cell products will be assessed
28 days
Estimate the maximum tolerated dose (MTD) and dose limiting toxicities (DLT), and describe the full toxicity profile of the two CAR T cell products
84 Days
Number of Arm A and Arm B subjects with persistence of CAR T cells in the peripheral blood at each visit time point
To quantitate anti-tumor responses by measuring changes in tumor burden using disease-specific evaluations and describe survival characteristics following CAR T cell infusion
84 days
Number of Arm A and Arm B subjects with persistence of CAR T cells in the bone marrow at each visit time point

Trial Safety

Trial Design

2 Treatment Groups

EGFR 806CAR(2G) -EGFRt
1 of 2
EGFR806CAR(2G)-EGFRt and CD19CAR(2G)-T2A-HER2tG
1 of 2
Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: second generation 4-1BBζ EGFR806-EGFRt · No Placebo Group · Phase 1

EGFR 806CAR(2G) -EGFRt
Biological
Experimental Group · 1 Intervention: second generation 4-1BBζ EGFR806-EGFRt · Intervention Types: Biological
EGFR806CAR(2G)-EGFRt and CD19CAR(2G)-T2A-HER2tG
Biological
Experimental Group · 1 Intervention: second generation 4-1BBζ EGFR806-EGFRt and a second generation 4 1BBζ CD19-Her2tG · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 84 days

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
262 Previous Clinical Trials
5,185,476 Total Patients Enrolled
1 Trials studying Wilms Tumor
68 Patients Enrolled for Wilms Tumor
Katie Albert, MDStudy ChairSeattle Children's Hospital

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
This text is saying that someone is able to tolerate apheresis or they have apheresis product available for use in manufacturing.
You have a score of 50 or higher on the Lansky or Karnofsky score.
, then the patient should be retreated with aGVHD prophylaxis If there is no apheresis product or T cell product available, then the patient should be retreated with aGVHD prophylaxis at least 7 days after the last chemotherapy or biologic therapy administration.
This means that a person can expect to live for at least 8 weeks.
, she now experiences occasional shortness of breath and fluid retention After all the chemotherapy, immunotherapy, and radiotherapy she's been through, she occasionally experiences shortness of breath and fluid retention.
If no apheresis product or T cell product is available,≥ 3 half lives or 30 days, whichever is shorter, post last dose of anti-tumor antibody therapy (including check point inhibitor) is required.
The first two subjects who enrolled and were treated in both Arm A and Arm B were between the ages of 15 and 30 years old.
vIII A malignant, non-CNS solid tumor expressing EGFRvIII is a tumor that is histologically diagnosed as being malignant and that expresses the EGFRvIII protein.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: October 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.