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CAR T-cell Therapy

CAR T-Cell Therapy for Sarcoma

Phase 1

Waitlist Available

Led By Nabil M Ahmed, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Bilirubin 3x or less, AST 3x or less, Serum creatinine 2x upper limit of normal or less, Hgb 7.0 g/dl or greater, WBC greater than 2,000/ul, ANC greater than 1,000/ul, platelets greater than 100,000/ul. Creatinine clearance is needed for patients with creatinine greater than 1.5 times upper limit of normal

Available autologous transduced T lymphocytes with 15% or more expression of HER2 CAR as determined by flow-cytometry and killing of HER2-positive targets 20 % or greater in cytotoxicity assay

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that uses patients' own immune cells. Researchers will insert a new gene into the cells that will make them better at fighting the cancer. The cells will be given to patients after they have received chemotherapy, which should help the cells to better fight the cancer.

Who is the study for?

This trial is for patients with HER2-positive sarcoma that's resistant to treatment or has spread, and who've tried at least one therapy before. They should have recovered from previous chemo effects, have a decent quality of life score (Karnofsky/Lansky score), normal heart function, reasonable life expectancy (6 weeks+), stable blood counts and organ functions. They must not be HIV positive, pregnant, breastfeeding, have severe infections or allergies to certain drugs.Check my eligibility

What is being tested?

The study tests genetically modified T cells designed to target and kill cancer cells in advanced sarcoma by introducing a new gene making them recognize the HER2 protein on tumors. It also examines if using chemotherapy (fludarabine alone or with cyclophosphamide) before T cell infusion – known as lymphodepletion – can enhance the treatment's effectiveness.See study design

What are the potential side effects?

Potential side effects include reactions related to immune response such as fever and fatigue; possible damage to non-cancerous cells that may express low levels of HER2; chemotherapy-related side effects like nausea, hair loss; increased risk of infection due to lowered white blood cell count.

Eligibility Criteria

Inclusion Criteria

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

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My T cells are modified to target HER2 and show strong activity against HER2 cancer cells.

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I have been diagnosed with a type of sarcoma or osteosarcoma that is HER2 positive and does not respond to treatment.

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My sarcoma is HER2-positive and has worsened despite treatment.

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I am able to live with some level of independence.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of patients with dose limiting toxicity after one injection of HER2-specific T cells

Secondary outcome measures

Change in tumor size from pre to post injection

Frequency of HER2-specific T cells pre and post injection

Trial Design

4Treatment groups

Experimental Treatment

Group I: HER2-specific T cells+fludarabineExperimental Treatment2 Interventions

Autologous HER2-specific T cells+fludarabine: Dose Level 9A: fludarabine followed by 1x10^8 cells/m^2

Group II: HER2-specific T cells+fludarab.+cycloph.Experimental Treatment3 Interventions

Autologous HER2-specific T cells+fludarabine+cyclophosphamide: Dose Level 9B: fludarabine + cyclophosphamide followed by 1x10^8 cells/m^2

Group III: CAR Positive cellsExperimental Treatment4 Interventions

Dose Level 9C: fludarabine + cyclophosphamide followed by 1x10^8 cells/m^2 CAR positive cells/m^2

Group IV: Autologous HER2-specific T cellsExperimental Treatment1 Intervention

THIS ARM IS CLOSED Dose Level 1: 1x10^4 cells/m2 Dose Level 2: 3x10^4 cells/m2 Dose Level 3: 1x10^5 cells/m2 (NOT BEING USED) Dose Level 4: 3x10^5 cells/m2 (NOT BEING USED) Dose Level 5: 1x10^6 cells/m2 Dose Level 6: 3x10^6 cells/m2 Dose Level 7: 1x10^7 cells/m2 Dose Level 8: 3x10^7 cells/m2 Dose Level 9: 1x10^8 cells/m2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3780

Fludarabine

2012

Completed Phase 3

~1100

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,781 Total Patients Enrolled

2 Trials studying Sarcoma

119 Patients Enrolled for Sarcoma

Cancer Prevention Research Institute of TexasOTHER

50 Previous Clinical Trials

98,402 Total Patients Enrolled

1 Trials studying Sarcoma

94 Patients Enrolled for Sarcoma

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,339 Total Patients Enrolled

1 Trials studying Sarcoma

94 Patients Enrolled for Sarcoma

Media Library

Autologous CAR Positive T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00902044 — Phase 1

Sarcoma Research Study Groups: Autologous HER2-specific T cells, HER2-specific T cells+fludarab.+cycloph., HER2-specific T cells+fludarabine, CAR Positive cells

Sarcoma Clinical Trial 2023: Autologous CAR Positive T cells Highlights & Side Effects. Trial Name: NCT00902044 — Phase 1

Autologous CAR Positive T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00902044 — Phase 1

Frequently Asked Questions

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

Could you elaborate on the potential risks associated with Autologous HER2-specific T cells?

"Autologous HER2-specific T cells have been assigned a score of 1 on the safety scale due to this being an early stage clinical trial, with data supporting efficacy and safety still limited."

Answered by AI

What conditions are Autologous HER2-specific T cells most commonly used in the treatment of?

"Autologous HER2-specific T cells are frequently utilized to treat multiple sclerosis, but may also be effective in combating mixed-cell type lymphomas, leukemias, myelocytic acute and retinoblastoma."

Answered by AI

How many participants has this trial attracted?

"At this moment, enrollment has closed for the clinical trial in question. Initially posted on February 11th 2010 and last edited November 21st 2022, if you are searching for other studies there exist 443 sarcoma trials and 889 Autologous HER2-specific T cell trials actively recruiting patients."

Answered by AI

Could you detail any other experiments using Autologous HER2-specific T cells?

"Currently, there are 889 clinical studies into Autologous HER2-specific T cells with 161 of these trials in the third phase. While Philadelphia contains a large number of such trials, 28443 locations across the globe have ongoing research about this topic."

Answered by AI

Is it possible to join the research study at this time?

"According to information found on clinicaltrials.gov, this particular medical study is no longer recruiting patients. Initially posted in February of 2010 and last edited November 21st 2022, the trial has since moved onto other phases; however, 1,332 different trials are still looking for participants."

Answered by AI

Recent research and studies

Nature CommunicationsJournal

Tumor Response and Endogenous Immune Reactivity After Administration of HER2 CAR T Cells in a Child with Metastatic Rhabdomyosarcoma

Hegde, Meenakshi, Sujith K. Joseph, Farzana Pashankar, Christopher DeRenzo, Khaled Sanber, Shoba Navai, Tiara T. Byrd, et al.. 2020. “Tumor Response and Endogenous Immune Reactivity After Administration of HER2 CAR T Cells in a Child with Metastatic Rhabdomyosarcoma”. Nature Communications. Springer Science and Business Media LLC. doi:10.1038/s41467-020-17175-8.

clinicaltrials.govStudy

Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma

Nabil Ahmed 2010. "Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00902044.

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