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CAR T-cell Therapy

CAR T Cell Therapy for Brain Cancer

Q: Has the Food and Drug Administration given its blessing to (C7R)-GD2.CART cells?

There is sparse evidence on the safety and efficacy of (C7R)-GD2.CART cells, so it was assigned a score of 1.

Q: Is this exploration presently recruiting participants?

Per the information on clinicaltrials.gov, this trial is actively looking for participants. It was first published on February 3rd 2020 and last updated November 8th 2022.

Q: What sorts of conditions are generally treated with (C7R)-GD2.CART cells?

The (C7R)-GD2.CART cell therapy is frequently used to manage <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, but can also be effective in the treatment of mixed-cell type <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, acute <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myelocytic <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> and retinoblastoma.

Q: What other investigations have there been on the efficacy of (C7R)-GD2.CART cells?

Presently, 889 clinical trials are in progress examining (C7R)-GD2.CART cells; 161 of which have entered the final phase before approval. The majority of the studies for this potential treatment reside in Philadelphia, PA yet many other locations across 28443 cities and towns also offer these interventions.

Q: Is the participation of elderly individuals sought for this clinical experiment?

The eligibility criteria for this trial requires that participants are above the age of 12 months and below 21 years old.

Q: What is the cap for patient enrollment in this research trial?

Affirmative. The information available on clinicaltrials.gov attests that this investigation is currently looking for enrollees. It was initially posted in February of 2020 with the most recent update occurring on November 8th 2022 and requires 34 participants from a single location to participate.

Phase 1

Recruiting

Led By Bilal Omer, 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

Tumors less than 5 cm in maximum dimension at enrollment

Tumors with sizes between 5 and 5.5 cm are eligible if the tumor was surgically debulked

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 weeks post t cell infusion

Awards & highlights

Study Summary

This trial is for patients with high grade glioma (HGG), diffuse intrinsic pontine glioma (DIPG), medulloblastoma, or another rare brain cancer. Patients will receive an infusion of GD2-C7R T cells, which are special immune cells that have been modified to better recognize and kill cancer cells. Researchers will also evaluate how long the GD2-C7R T cells can be detected in the blood and what effect they have on brain cancer.

Who is the study for?

This trial is for children and young adults aged 1 to 21 with specific brain cancers that have a protein called GD2 on their surface. These include newly diagnosed or recurrent tumors like diffuse midline glioma, high-grade glioma, medulloblastoma, and others. Participants need measurable disease on MRI and a functional score indicating they can perform daily activities at least half the time.Check my eligibility

What is being tested?

The study tests genetically modified T cells (a type of immune cell) designed to last longer in the body by adding a gene called C7R. This helps them fight cancer more effectively. The trial involves two methods of infusing these cells: directly into the brain (ICV) and into the vein (IV), after chemotherapy to improve their survival.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune response such as inflammation, fever, fatigue; complications from infusion; possible neurological symptoms due to direct brain infusion; and typical risks associated with chemotherapy used before T cell infusion.

Eligibility Criteria

Inclusion Criteria

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

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My tumor is smaller than 5 cm.

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My tumor was between 5 and 5.5 cm but was surgically reduced in size.

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My tumor is newly diagnosed or recurrent and tests positive for GD2 or H3K27M.

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I am between 1 and 21 years old.

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I am expected to be mostly self-caring at the time of treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 weeks post t cell infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 weeks post t cell infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 weeks post t cell infusion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dose limiting toxicity (DLT) rate

Secondary outcome measures

Response rate according to standard criteria

Trial Design

1Treatment groups

Experimental Treatment

Group I: C7R-GD2.CAR T cellsExperimental Treatment2 Interventions

The dose level for autologous cell C7R-GD2.CART cell immunotherapy administered via intravenous (IV) infusion was determined in the initial phase of the protocol. The IV dosing is 30 million cells/m2 (two equal half-doses of 15 million cells/m2) given at least 5 days and no greater than 10 days apart. Infusion 1 will be given at least 5 days after initial ICV infusion. The second half dose will be given at least 5 days after infusion 1 and will be delayed if CRS or ICANS of Grade 2 or higher is present. In this subsequent phase of the study, the safe dosing levels for autologous cell C7R-GD2.CART cell immunotherapy administered intracerebroventricularly (ICV) via ommaya reservoir or programmable VP shunt in combination with subsequent IV doses will be determined.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Faris FoundationUNKNOWN

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,783 Total Patients Enrolled

Violet Foundation for Pediatric Brain CancerUNKNOWN

Media Library

(C7R)-GD2.CART cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04099797 — Phase 1

Diffuse Intrinsic Pontine Glioma Research Study Groups: C7R-GD2.CAR T cells

Diffuse Intrinsic Pontine Glioma Clinical Trial 2023: (C7R)-GD2.CART cells Highlights & Side Effects. Trial Name: NCT04099797 — Phase 1

(C7R)-GD2.CART cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04099797 — Phase 1

Frequently Asked Questions

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

Who has been identified as suitable candidates for participation in this clinical trial?

"The clinical trial is aiming to recruit 34 children aged between 12 Months and 21 with diffuse intrinsic pontine glioma. To be eligible, they must fulfill several criteria such as having a histologically confirmed GD2-expressing diagnosis or H3K27M mutation status, tumors that are under 5 cm in size at the time of enrollment, an ANC >1000 cells/ul and platelet count >100000 cells/ul, total bilirubin < 1.5x ULN etc.."

Answered by AI

Has the Food and Drug Administration given its blessing to (C7R)-GD2.CART cells?

"There is sparse evidence on the safety and efficacy of (C7R)-GD2.CART cells, so it was assigned a score of 1."

Answered by AI

Is this exploration presently recruiting participants?

"Per the information on clinicaltrials.gov, this trial is actively looking for participants. It was first published on February 3rd 2020 and last updated November 8th 2022."

Answered by AI

What sorts of conditions are generally treated with (C7R)-GD2.CART cells?

"The (C7R)-GD2.CART cell therapy is frequently used to manage multiple sclerosis, but can also be effective in the treatment of mixed-cell type lymphoma, acute leukemia, myelocytic cancer and retinoblastoma."

Answered by AI

What other investigations have there been on the efficacy of (C7R)-GD2.CART cells?

"Presently, 889 clinical trials are in progress examining (C7R)-GD2.CART cells; 161 of which have entered the final phase before approval. The majority of the studies for this potential treatment reside in Philadelphia, PA yet many other locations across 28443 cities and towns also offer these interventions."

Answered by AI

Is the participation of elderly individuals sought for this clinical experiment?

"The eligibility criteria for this trial requires that participants are above the age of 12 months and below 21 years old."

Answered by AI

What is the cap for patient enrollment in this research trial?

"Affirmative. The information available on clinicaltrials.gov attests that this investigation is currently looking for enrollees. It was initially posted in February of 2020 with the most recent update occurring on November 8th 2022 and requires 34 participants from a single location to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)

Bilal Omer 2020. "C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04099797.

All > Brain Cancer > Brain Tumor