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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

Must not have

Severe previous toxicity from cyclophosphamide or fludarabine

At time of Treatment: Severe intercurrent infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I had severe side effects from cyclophosphamide or fludarabine.

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I do not have a severe infection at the time of treatment.

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

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

Primary study objectives

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

Secondary study objectives

Change in tumor size from pre to post injection

Frequency of HER2-specific T cells pre and post injection

Awards & Highlights

No Placebo-Only Group

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

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

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860