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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 plus/minus 7 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 plus/minus 7 days

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

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

Primary outcome measures

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 outcome measures

Overall Response rate according to RECIST 1.1 Criteria SD, PR and CR are considered responders.

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,699 Previous Clinical Trials

7,508,474 Total Patients Enrolled

12 Trials studying Sarcoma

1,069 Patients Enrolled for Sarcoma

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,227 Total Patients Enrolled

2 Trials studying Sarcoma

130 Patients Enrolled for Sarcoma

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,792 Total Patients Enrolled

2 Trials studying Sarcoma

130 Patients Enrolled for Sarcoma

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

Frequently Asked Questions

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

Does this clinical trial accept participants who are older than 30?

"The parameters for this trial indicate that it is only available to those aged 1 year and 25 years old. There are 537 clinical trials open to minors while 2,596 studies accommodate senior citizens."

Answered by AI

Are there still openings for research participants in this experiment?

"Yes, the information posted on clinicaltrials.gov notes that this research is presently enrolling patients. It was first shared on December 7th 2021 and was subsequently updated one day later. This medical experiment needs to recruit 25 people from a single site."

Answered by AI

For whom is this research opportunity suitable?

"This clinical research is recruiting 25 individuals aged between one year and twenty-five years that have been diagnosed with sarcoma. In addition to having a HER2 positive diagnosis, confirmed via immunohistochemistry (IHC), participants must possess a Karnofsky/Lansky performance score of ≥60 and be at least four weeks away from their last cytotoxic chemotherapy or seven days after any targeted noncytotoxic drug treatment. The intensity of the staining needs to be graded as negative; 1+; 2+; or 3+, while its expression should reach grades 0 through 3 in terms of how many tumor cells are positively"

Answered by AI

What is the uppermost cap of participants for this clinical trial?

"Confirmed. Clinicaltrials.gov verifies that this research is actively enrolling participants, which was first advertised on December 7th 2021 and most recently updated the day after. This trial seeks 25 individuals from a single medical centre.."

Answered by AI

To what degree is Lymphodepletion Chemotherapy associated with adverse effects?

"Given the limited data regarding its efficacy and safety, our team at Power assigned Lymphodepletion Chemotherapy a score of 1 on a scale from 1 to 3."

Answered by AI

What ailments is Lymphodepletion Chemotherapy employed to treat?

"Lymphodepletion Chemotherapy is traditionally used to treat those whose cancer has been completely removed. Additionally, this treatment can be effective in managing the development of certain diseases such as hodgkin's disease and metastatic cutaneous squamous cell carcinoma."

Answered by AI

Are there any other recorded instances of Lymphodepletion Chemotherapy being tested in a controlled setting?

"Presently, there are 2466 active trials investigating Lymphodepletion Chemotherapy. 357 of those medical studies have entered Phase 3 and the majority originate from Philadelphia in Pennsylvania. 99827 different locations are running these clinical investigations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma

Meenakshi Hegde, M.D. 2021. "HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04995003.

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