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Alkylating agents
CAR T-Cell Therapy for Pediatric Brain Cancer
Phase 1
Recruiting
Led By Leo D Wang
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
City of Hope (COH) clinical pathology confirms IL13Ralpha2+ tumor expression by immunohistochemistry (IHC) at the initial tumor presentation or recurrent disease (H-score >= 50)
Participant has a prior histologically-confirmed malignant brain neoplasm and has progressed after prior conventional therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of lymphodepletion to the event date (progressionor death), assessed at 6 months
Awards & highlights
Study Summary
This trial is testing a new treatment for children with brain tumors that have come back or are resistant to treatment. The new treatment is a combination of chemotherapy and cellular immunotherapy, which uses brain-tumor specific cells to change the body's immune system.
Who is the study for?
This trial is for children with IL13Ralpha2 positive brain tumors that have returned or are not responding to treatment. They must have good kidney function, no severe infections, and a certain level of physical ability despite their illness. Children who are pregnant, breastfeeding, or unable to follow the study procedures cannot participate.Check my eligibility
What is being tested?
The trial tests chemotherapy (cyclophosphamide and fludarabine) combined with cellular immunotherapy using CAR T cells targeting IL13Ralpha2 on tumor cells. It aims to see if this combination can better kill tumor cells in children whose brain cancer has come back or isn't responding.See study design
What are the potential side effects?
Possible side effects include reactions from the immune system attacking normal tissues (autoimmunity), symptoms from cell infusions like fever and chills, low blood counts leading to increased infection risk, nausea from chemotherapy, and potential organ damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor tested positive for IL13Ralpha2 based on a specific test.
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My brain cancer has returned or worsened after standard treatment.
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I don't need extra oxygen to maintain my oxygen levels and my chest x-ray doesn’t show worsening issues.
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I take no more than 6mg/day of Dexamethasone.
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My kidney function is normal, with a creatinine level below 1.8 mg/dL.
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I do not have seizures that are currently uncontrolled.
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I don't need extra oxygen to maintain my oxygen levels above 95% and my chest x-ray shows no worsening issues.
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I don't need medication to maintain my blood pressure and I don't have irregular heartbeats that cause symptoms.
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I don't have a fever above 38.5°C, no recent infections, and no signs of meningitis.
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I have tested negative for HIV, hepatitis B, and hepatitis C recently.
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I have a frozen T cell product ready for use.
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I do not need medication to maintain my blood pressure and do not have irregular heartbeats.
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My liver tests are within twice the normal range.
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I can care for myself but may not be able to do active work.
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I don't need more than a low dose of dexamethasone during my therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of lymphodepletion to the event date (progressionor death), assessed at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of lymphodepletion to the event date (progressionor death), assessed at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
CAR T cells detected in tumor tissue
Circulating tumor deoxyribonucleic acid (ctDNA) assessments
Disease response
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, IL13(EQ)BBzeta/CD19t+ T cells)Experimental Treatment3 Interventions
Patients receive cyclophosphamide intravenously IV on days -5 and -4, and fludarabine IV on days -5 to -2. Patients then receive autologous IL13(EQ)BBzeta/CD19t+ T cells intraventricularly over 5 minutes QW on day 0. Treatment with autologous IL13(EQ)BBzeta/CD19t+ T cells repeats every 7 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles of IL13(EQ)BBzeta/CD19t+ T cells as long as they continue to meet eligibility criteria and have doses available for infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,442 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,863 Total Patients Enrolled
Leo D WangPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on dialysis.You have tested positive for HIV within the past 4 weeks.Your ALT and AST levels in the blood are not more than twice the normal limit.Your liver function test (AST) is not more than twice the upper limit of normal.I do not have a fever over 38.5°C or any recent positive tests for infections.I am eligible for a CNS catheter placement.If you have hepatitis C, you need to get a test to see how much virus is in your blood.Your bilirubin levels are not more than twice the normal limit, unless you have Gilbert's disease.I can care for myself but may not be able to walk due to my illness.If you have a shunt, it must be adjustable, and you should be able to handle it being turned off for at least 2 days in a row.I am not currently being treated for a severe infection or recovering from major surgery.It has been over 2 weeks since my last cancer treatment.My tumor tested positive for IL13Ralpha2 based on a specific test.Your kidneys are working well, and you can clear creatinine efficiently from your body.My brain cancer has returned or worsened after standard treatment.My cancer has grown or come back more than 12 weeks after my first treatment ended.I don't need extra oxygen to maintain my oxygen levels and my chest x-ray doesn’t show worsening issues.Your blood clotting test (INR) should be less than or equal to 1.3.Women who can have babies: You need to have a negative pregnancy test before joining the study. If the urine test is positive or not clear, you will need to have a blood test for pregnancy.Your blood creatinine level is less than 1.6 mg/dL.Your bilirubin levels are less than 1.5 mg/dL.I take no more than 6mg/day of Dexamethasone.Your body has enough infection-fighting white blood cells.My kidney function is normal, with a creatinine level below 1.8 mg/dL.I have seizures or worsening brain function that isn't under control.I do not have uncontrolled seizures after surgery and before starting lymphodepletion.I understand the study's purpose, procedures, and the risks/benefits of participating.I am eligible for a treatment that reduces my white blood cells.I do not have seizures that are currently uncontrolled.I don't need extra oxygen to maintain my oxygen levels above 95% and my chest x-ray shows no worsening issues.Your blood tests for liver function should not show levels of bilirubin or transaminases higher than twice the normal limit.I need medication to support my blood pressure or have heart rhythm problems.I don't need medication to maintain my blood pressure and I don't have irregular heartbeats that cause symptoms.I don't have a fever above 38.5°C, no recent infections, and no signs of meningitis.I am eligible for CAR T cell therapy.I have tested negative for HIV, hepatitis B, and hepatitis C recently.I do not have any uncontrolled illnesses or active infections, including hepatitis B or C.I have a frozen T cell product ready for use.I finished my last chemotherapy more than 23 days ago, or 4 weeks if it was not temozolomide.You have more than 50,000 platelets per microliter of blood.I do not need medication to maintain my blood pressure and do not have irregular heartbeats.I need extra oxygen to maintain my oxygen levels above 95%, and this won't improve in 2 weeks.I am not pregnant or breastfeeding.My liver tests are within twice the normal range.Your blood creatinine level is less than 1.8 mg/dL.I have not taken bevacizumab in the last 4 weeks.Your platelet count is at least 50,000 per cubic millimeter.I can care for myself but may not be able to do active work.You are expected to live for more than 4 weeks.I am eligible for a blood cell collection procedure.Your liver enzyme levels are not more than twice the normal limit.I do not have any other active cancers.Your white blood cell count is at least 2,000 per microliter.I completed my second round of radiation therapy at least 4 weeks ago.My platelet count is at least 50,000 or has been raised to this level with a transfusion.I don't need more than a low dose of dexamethasone during my therapy.It has been over 6 weeks since I finished my nitrosourea chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (chemotherapy, IL13(EQ)BBzeta/CD19t+ T cells)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 still have spots available for participants?
"Clinicaltrials.gov indicates that this scientific endeavour is actively seeking participants. The trial was inaugurated on December 4th 2020 and recently modified May 19th 2022."
Answered by AI
Is the FDA's approval of autonomous T-cells, which have been modified to express CD19 and a 41BB co-stimulatory carboxy-terminus containing IL13Ralpha2 specific Hinge Optimization, attained?
"Based on the limited evidence available, our team at Power has estimated IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes to be relatively safe and allotted it a score of 1."
Answered by AI
Has research been conducted on autologous T-lymphocytes expressing CD19 and a 41BB co-stimulatory CAR that is IL13Ralpha2 specific, with an optimized hinge?
"Currently, 889 studies are in progress to investigate the efficacy of IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes with 161 trials at Phase 3. Notably, Philadelphia is home to most of these clinical trials; however, there are 28446 other locations where research related to this intervention can be conducted."
Answered by AI
What criteria are being sought in prospective participants of this trial?
"To be considered for this clinical trial, individuals must possess a malignant brain tumour and have reached the age of 4 but not beyond 25 years old. A maximum of 18 participants are allowed to enrol in this medical experiment."
Answered by AI
What is the upper bound of participants in this clinical trial?
"Correct. As per the clinicaltrials.gov website, this research is still recruiting patients as of May 19th 2022- which was shortly after its initial posting on December 4th 2020. 18 participants from 1 medical centre are needed for the study."
Answered by AI
Does this clinical trial admit participants that are over 35 years of age?
"This trial has set the age limit at 4 years old to 25 years of age, as specified in its eligibility criteria."
Answered by AI
What medical condition has been found to benefit from the utilization of IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes?
"IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes is regularly used to manage multiple sclerosis and several other ailments such as mixed cell type lymphoma, acute myelocytic leukemia, and retinoblastoma."
Answered by AI
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