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Alkylating agents

CAR T-Cell Therapy + Checkpoint Inhibitors for Sarcoma

Phase 1
Recruiting
Led By Meenakshi Hegde, 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
Karnofsky or Lansky performance score of ≥ 60
Age between 1 to 25 years
Must not have
Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Presence of bulky tumor at the primary or metastatic site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 plus/minus 7 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether it is safe to give HER2-CAR T cells in combination with pembrolizumab or nivolumab to patients with advanced solid tumors, including sarcomas.

Who is the study for?
This trial is for young patients aged 1-25 with HER2-positive sarcoma, who have normal heart function and organ health. They must not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and have no severe allergies to the drugs used in this study. Patients with certain heart conditions, active infections, HIV or tuberculosis are excluded.
What is being tested?
The trial tests a combination of genetically modified T cells (HER2-CAR T cells) and immune checkpoint inhibitors (pembrolizumab or nivolumab). It aims to see if this mix can safely treat advanced sarcoma by enhancing the body's immune response against cancer after pre-treatment with lymphodepletion chemotherapy.
What are the potential side effects?
Potential side effects include reactions related to CAR T-cell therapy such as fever, fatigue, and low blood cell counts; complications from chemotherapy like nausea; and autoimmune-like symptoms due to checkpoint inhibitors which may cause inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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I am between 1 and 25 years old.
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My sarcoma is HER2-positive with a certain level of HER2.
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I have recovered from the side effects of my last cancer treatment.
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My T cells are engineered to target HER2 and are effective against HER2-positive cancer cells.
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My heart's pumping ability is normal.
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My kidney function, measured by creatinine, is within the normal range for my age.
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My HER2 positive sarcoma has worsened or returned after treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.
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My cancer has formed a large tumor.
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I have an active case of tuberculosis.
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I have had lung inflammation treated with steroids or have it now.
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I have an immune system disorder or am taking medication to suppress my immune system.
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I have had severe side effects from cyclophosphamide.
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My heart's pumping ability is below normal, or I have severe heart problems.
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I have had severe side effects from fludarabine, such as nerve damage, coma, kidney injury needing dialysis, severe anemia, or a new cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 plus/minus 7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 plus/minus 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ARM A: Dose-limiting toxicity (DLT) rate by CTCAE v5.0. Neurotoxicity and cytokine release syndrome (CRS) will be graded according to ASTCT Consensus Grading System.
ARM B: Dose-limiting toxicity (DLT) rate by CTCAE v5.0. Neurotoxicity and cytokine release syndrome (CRS) will be graded according to ASTCT Consensus Grading System.
Secondary study objectives
Overall Response rate according to RECIST 1.1 Criteria SD, PR and CR are considered responders.

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: Arm AExperimental Treatment2 Interventions
autologous HER2 CAR T cells infused in combination with lymphodepletion chemotherapy and the PD-1 antibody pembrolizumab
Group II: Arm 2Experimental Treatment2 Interventions
autologous HER2 CAR T cells infused in combination with lymphodepletion chemotherapy and the PD-1 antibody nivolumab

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,595 Total Patients Enrolled
13 Trials studying Sarcoma
1,087 Patients Enrolled for Sarcoma
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,137 Total Patients Enrolled
2 Trials studying Sarcoma
130 Patients Enrolled for Sarcoma
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,829 Total Patients Enrolled
2 Trials studying Sarcoma
130 Patients Enrolled for Sarcoma
The Faris Foundation USAUNKNOWN
Stand Up To CancerOTHER
52 Previous Clinical Trials
40,096 Total Patients Enrolled
2 Trials studying Sarcoma
182 Patients Enrolled for Sarcoma
Triumph Over Kid Cancer FoundationUNKNOWN
St. Baldrick's FoundationOTHER
18 Previous Clinical Trials
9,113 Total Patients Enrolled
2 Trials studying Sarcoma
50 Patients Enrolled for Sarcoma
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,062 Total Patients Enrolled
460 Trials studying Sarcoma
229,816 Patients Enrolled for Sarcoma
Meenakshi Hegde, MDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
60 Total Patients Enrolled
Shoba Navai, MDPrincipal InvestigatorBaylor College of Medicine
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Cyclophosphamide and Fludarabine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04995003 — Phase 1
Sarcoma Research Study Groups: Arm A, Arm 2
Sarcoma Clinical Trial 2023: Cyclophosphamide and Fludarabine Highlights & Side Effects. Trial Name: NCT04995003 — Phase 1
Cyclophosphamide and Fludarabine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04995003 — Phase 1
~12 spots leftby Dec 2027
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