GlioblastomaPhase 1NCT03389230

Memory-Enriched T Cells in Treating Patients With Recurrent or Refractory Grade III-IV Glioma

A Phase 1 study testing HER2(EQ)BBζ/CD19t+ T cells, Laboratory Biomarker Analysis and Leukapheresis in people with Glioblastoma and Malignant Glioma, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Glioblastoma, Malignant Glioma, Recurrent Glioma
What is being tested?: HER2(EQ)BBζ/CD19t+ T cells, Laboratory Biomarker Analysis and Leukapheresis
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 14 Aug 2018to 29 Dec 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has a prior histologically-confirmed diagnosis of a grade III or IV glioma, or has a prior histologically-confirmed diagnosis of a grade II glioma and now has radiographic progression consistent with a grade III or IV malignant glioma (MG)
Karnofsky performance status (KPS) >= 60%
Life expectancy > 4 weeks
The effects of HER2(EQBBzeta/CD19t+ T cells on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
City of Hope (COH) Clinical Pathology confirms HER2+ tumor expression by immunohistochemistry (>= 20%, 1+)
All research participants must have the ability to understand and the willingness to sign a written informed consent

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Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with rickham placement and CAR T cell infusion only after the translated full consent form is signed
ELIGIBILITY TO PROCEED WITH PERIPHERAL BLOOD MONONUCLEAR CELL (PBMC) COLLECTION
Research participant must not require more than 2 mg three times daily (TID) of dexamethasone on the day of PBMC collection.
Research participant must have appropriate venous access
At least 2 weeks must have elapsed since the research participant received his/her last dose of prior targeted agents, chemotherapy or radiation; at the principal investigator's discretion, exception can be made for investigational agents that are delivered locally into the CSF
ELIGIBILITY TO PROCEED WITH RICKHAM PLACEMENT
Once research participants meet eligibility to proceed with Rickham placement, they will be deemed accrued on to the study
Note: if the participant had received prior targeted radiation and new lesions have appeared outside of that targeted area, then that may be deemed radiographic evidence of measurable disease even if 12 weeks have not elapsed
Creatinine < 1.6 mg/dL
White blood cell (WBC) > 2,000/dl (or absolute neutrophil count [ANC] > 1,000)
Platelets >= 100,000/dl
International normalized ratio (INR) < 1.3
Bilirubin < 1.5 mg/dL
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limits of normal
ELIGIBILITY TO PROCEED WITH CAR T CELL INFUSION
Research participant has a released cryopreserved CAR T cell product
Research participant does not require supplemental oxygen to keep saturation greater than 95% and/or does not have presence of any radiographic abnormalities on chest x-ray that are progressive
Research participants does NOT have any known history of congestive heart failure (CHF) or cardiac symptoms consistent with NYHA classification III-IV within 6 months prior to Day 1 of protocol treatment, cardiomyopathy, myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications or with clinical history suggestive of the above must have an EKG and echocardiogram (ECHO) performed within 42 days prior to registration and as clinical indicated while on treatment
If the research participant has new symptoms of CHF, cardiomyopathy, myocarditis, MI, or exposure to cardiotoxic medications they already had a cardiac consultation, creatinine phosphokinase (CPK), and troponin testing at pre study deeming them fit for study participation
Research participant does not have a fever exceeding 38.5 degrees Celsius (C); there is an absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to T cell infusion and/or there aren't any indications of meningitis
Research participant serum total bilirubin or transaminases does not exceed 2 x normal limit
Research participant serum creatinine < 1.8 mg/dL
Research participant does not have uncontrolled seizure activity following surgery prior to starting the first T cell dose
Research participant platelet count must be > 100,000; however, if platelet level is between 75,000-99,000, then CAR T-cell infusion may proceed after platelet transfusion is given and the post transfusion platelet count is >= 100,000
Research participants must not require more than 2 mg TID of dexamethasone during CAR T cell therapy
Wash-out requirements (standard or investigational):
At least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen; and
At least 23 days must have passed since the completion of Temodar and/or 4 weeks for any other non-nitrosourea-containing cytotoxic chemotherapy regimen; if a participant's most recent treatment was with a targeted agent only, and s/he has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose and the start of CAR T cell infusion with the exception of bevacizumab where a wash out period of at least 4 weeks is required before starting CAR T cell therapy

Who cannot join

Research participant requires supplemental oxygen to keep saturation greater than 95% and the situation is not expected to resolve within 2 weeks
Research participants with a known history of congestive heart failure (CHF) or cardiac symptoms consistent with New York Heart Association (NYHA) classification III-IV within 6 months prior to Day 1 of protocol treatment, cardiomyopathy, myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications or with clinical history suggestive of the above must have an electrocardiogram (EKG) and echocardiogram (ECHO) performed within 42 days prior to registration and as clinically indicated while on treatment
Research participants with new symptoms of CHF, cardiomyopathy, myocarditis, MI, or exposure to cardiotoxic medications must have a cardiac consultation, creatinine phosphokinase (CPK), and troponin testing at pre -study and as clinically indicated
Research participant requires dialysis
Research participant has uncontrolled seizure activity and/or clinically evident progressive encephalopathy
Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I study; a legal guardian may substitute for the research participant

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Research participants with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the research participant on protocol shall be ineligible
Research participants with any other active malignancies
Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Research participants who have confirmed human immunodeficiency virus (HIV) positivity within 4 weeks of enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

City of Hope Medical Center
Duarte, California, 91010

Other trials in United States

About this study

Official title: Phase I Study of Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a HER2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients With Recurrent/Refractory Malignant Glioma

This phase I trial studies the side effects and best dose of memory-enriched T cells in treating patients with grade II-IV glioma that has come back (recurrent) or does not respond to treatment (refractory). Memory enriched T cells such as HER2(EQ)BBζ/CD19t+ T cells may enter and express its genes in immune cells. Immune cells can be engineered to kill glioma cells in the laboratory by inserting a piece of deoxyribonucleic acid (DNA) into the immune cells that allows them to recognize glioma cells. A vector called lentivirus is used to carry the piece of DNA into the immune cell. It is not known whether these immune cells will kill glioma tumor cells when given to patients.

Read the detailed description

PRIMARY OBJECTIVES:

To assess the feasibility and safety of cellular immunotherapy utilizing ex vivo expanded autologous memory-enriched T cells that are genetically modified using a self-inactivating (SIN) lentiviral vector to express a HER2-specific, hinge-optimized, 41BB-costimulatory chimeric antigen receptor (CAR), as well as a truncated human CD19 (HER2[EQ]BBzeta/CD19t+) for participants with recurrent/refractory malignant glioma in one of the following ways: Arm 1 (intracavitary/intratumoral HER2(EQ)BBzeta/CD19+ T CM), Arm 2 (dual delivery [both intracavitary/intratumoral and intraventricular] of HER2(EQ)BBzeta/CD19+ T CM), or Arm 3 (dual delivery [both intracavitary/intratumoral and intraventricular] of HER2(EQ)BBzeta/CD19+ T N/MEM).

II. To determine maximum tolerated dose schedule (MTD) and a recommended Phase II dosing plan (RP2D) for arm 3 (dual delivery).

SECONDARY OBJECTIVES:

To describe persistence and expansion of CAR T cells in tumor cyst fluid, peripheral blood and cerebral spinal fluid (CSF).

II. To describe cytokine levels (tumor cyst fluid, peripheral blood, and CSF) over the study period.

III. In research participants who receive the full schedule of 3 CAR T cell doses:

IIIa. To estimate median progression free survival (PFS) rate. IIIb. To estimate disease response rates. IIIc. To estimate median overall survival (OS).

IV. In research participants who continue to receive infusions after progressing:

IVa. Estimate disease response. IVb. Describe CAR T cell and endogenous immune populations, as well as cytokine and microenvironment profiles (cerebral spinal fluid [CSF], cyst fluid, peripheral blood) considering post progression therapy(ies), if applicable.

For study participants who undergo an additional biopsy/resection or autopsy:

Va. Evaluate CAR T cell persistence in the tumor micro-environment and the location of the CAR T cells with respect to the injection.

Vb. Evaluate HER2 antigen expression levels pre and post CAR T cell therapy.

OUTLINE: This is a dose-escalation study of autologous HER2(EQ)BBζ/CD19t+ T cells. Participants are assigned to 1 of 3 arms.

ARM I: Patients receive autologous HER2(EQ)BBzeta/CD19t+ Tcm cells via intratumoral/intracavitary catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients remain eligible and there is product available. Patients who progress on intracavitary or intratumoral administration may move to alternative delivery routes for the optional infusions.

ARM II: Patients receive autologous HER2(EQ)BBzeta/CD19t+ Tcm cells via intratumoral/intracavitary catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites).

ARM III: Patients receive autologous HER2(EQ)BBzeta/CD19t+ Tn/mem cells via intratumoral/intracavitary catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites).

After completion of study treatment, patients are followed up at 4 weeks, 3, 6, 8, 10, and 12 months, then annually for at least 15 years.

Conditions: Glioblastoma, Malignant Glioma, Recurrent Glioma, Refractory Glioma, WHO Grade III Glioma
Being tested: HER2(EQ)BBζ/CD19t+ T cells, Laboratory Biomarker Analysis, Leukapheresis
Medical subject headings: Glioblastoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HER2(EQ)BBζ/CD19t+ T cellsBiological
Given via catheter
Laboratory Biomarker AnalysisOther
Correlative studies
LeukapheresisProcedure or surgery
Also called Leukocytopheresis, Therapeutic Leukopheresis
Undergo leukapheresis

Study groups in NCT03389230
Study group	Role	What they receive
Arm I (intratumoral/intracavitary delivery)	Experimental	Patients receive autologous HER2(EQ)BBzeta/CD19t+ Tcm cells via intratumoral/intracavitary catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients remain eligible and there is product available. Patients who progress on intracavitary or intratumoral administration may move to alternative delivery routes for the optional infusions. Receives: Biological: HER2(EQ)BBζ/CD19t+ T cells; Other: Laboratory Biomarker Analysis; Procedure: Leukapheresis
Arm II (dual delivery Tcm enriched)	Experimental	Patients receive autologous HER2(EQ)BBzeta/CD19t+ Tcm cells via intratumoral/intracavitary catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites). Receives: Biological: HER2(EQ)BBζ/CD19t+ T cells; Other: Laboratory Biomarker Analysis; Procedure: Leukapheresis
ARM III (dual delivery Tn/mem enriched)	Experimental	Patients receive autologous HER2(EQ)BBzeta/CD19t+ Tn/mem cells via intratumoral/intracavitary catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites). Receives: Biological: HER2(EQ)BBζ/CD19t+ T cells; Other: Laboratory Biomarker Analysis; Procedure: Leukapheresis

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of grade 3 adverse events
Tables will be created to summarize all toxicities and side effects by dose, time post treatment, organ, severity and arm.
Measured: Up to 3 years
Dose limiting toxicities (DLT)
Rate and associated 90% Clopper and Pearson binomial confidence limits (90% confidence interval [CI]) will be estimated for participants' experiencing DLTs at the recommended phase 2 dose (RP2D) schedule.
Measured: Up to 3 years
Incidence of adverse events
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Tables will be created to summarize all toxicities and side effects by dose, time post treatment, organ, severity and arm.
Measured: Up to 3 years

Secondary outcomes (7)

Chimeric antigen receptor (CAR) T cells detected in tumor cyst fluid, peripheral blood, and cerebrospinal fluid (CSF)
Statistical and graphical methods will be used to describe persistence and expansion of the CAR T cells (tumor cyst fluid, peripheral blood and CSF) over the study period. In study participants that undergo a second biopsy resection or following autopsy, T cells numbers, location, and antigen levels will be described.
Measured: Up to 3 years
Tumor cyst fluid, peripheral blood, and cerebrospinal fluid (CSF) cytokine levels
Statistical and graphical methods will be used to describe persistence and expansion of cytokine levels (tumor cyst fluid, peripheral blood, and CSF) over the study period.
Measured: Up to 3 years
Progression free survival
Kaplan Meier methods will be used
Measured: At 6 months
Overall Survival (OS)
Kaplan Meier methods will be used to estimate median OS and graph the results.
Measured: At 6 months
Disease response
Will be measured by Response Assessment in Neuro-Oncology Criteria (RANO) criteria. Will estimate the rate (90% CI) progression free at 6 months and rate (90% CI) with disease response.
Measured: Up to 3 years
Chimeric antigen receptor (CAR) T cells detected in tumor tissue
T cells numbers, location, and antigen levels will be described.
Measured: Up to 3 years
HER2 antigen expression levels in tumor tissue
Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 201829 Dec 2026

First posted3 Jan 2018
Study start14 Aug 2018
Primary completion29 Dec 2026 (estimated)
Study completion29 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GlioblastomaStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03389230
Sponsor's protocol ID: 16064
Other IDs: NCI-2017-01755, 16064, P30CA033572
Status last verified: Feb 2026
First submitted: 27 Dec 2017
Last updated: 4 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Study of Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a HER2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients With Recurrent/Refractory Malignant Glioma
ClinicalTrials.gov ID: NCT03389230
Acronym / sponsor ID: 16064
Conditions: Glioblastoma, Malignant Glioma, Recurrent Glioma, Refractory Glioma, WHO Grade III Glioma
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 29 participants (actual)
Lead sponsor: City of Hope Medical CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 14 Aug 2018 (actual)
Primary completion: 29 Dec 2026 (estimated)
Study completion: 29 Dec 2026 (estimated)
First posted: 3 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To assess the feasibility and safety of cellular immunotherapy utilizing ex vivo expanded autologous memory-enriched T cells that are genetically modified using a self-inactivating (SIN) lentiviral vector to express a HER2-specific, hinge-optimized, 41BB-costimulatory chimeric antigen receptor (CAR), as well as a truncated human CD19 (HER2[EQ]BBzeta/CD19t+) for participants with recurrent/refractory malignant glioma in one of the following ways: Arm 1 (intracavitary/intratumoral HER2(EQ)BBzeta/CD19+ T CM), Arm 2 (dual delivery [both intracavitary/intratumoral and intraventricular] of HER2(EQ)BBzeta/CD19+ T CM), or Arm 3 (dual delivery [both intracavitary/intratumoral and intraventricular] of HER2(EQ)BBzeta/CD19+ T N/MEM).

II. To determine maximum tolerated dose schedule (MTD) and a recommended Phase II dosing plan (RP2D) for arm 3 (dual delivery).

SECONDARY OBJECTIVES:

To describe persistence and expansion of CAR T cells in tumor cyst fluid, peripheral blood and cerebral spinal fluid (CSF).

II. To describe cytokine levels (tumor cyst fluid, peripheral blood, and CSF) over the study period.

III. In research participants who receive the full schedule of 3 CAR T cell doses:

IIIa. To estimate median progression free survival (PFS) rate. IIIb. To estimate disease response rates. IIIc. To estimate median overall survival (OS).

IV. In research participants who continue to receive infusions after progressing:

For study participants who undergo an additional biopsy/resection or autopsy:

Va. Evaluate CAR T cell persistence in the tumor micro-environment and the location of the CAR T cells with respect to the injection.

Vb. Evaluate HER2 antigen expression levels pre and post CAR T cell therapy.

OUTLINE: This is a dose-escalation study of autologous HER2(EQ)BBζ/CD19t+ T cells. Participants are assigned to 1 of 3 arms.

After completion of study treatment, patients are followed up at 4 weeks, 3, 6, 8, 10, and 12 months, then annually for at least 15 years.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm I (intratumoral/intracavitary delivery)	Experimental	Biological: HER2(EQ)BBζ/CD19t+ T cells, Other: Laboratory Biomarker Analysis, Procedure: LeukapheresisPatients receive autologous HER2(EQ)BBzeta/CD19t+ Tcm cells via intratumoral/intracavitary catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients remain eligible and there is product available. Patients who progress on intracavitary or intratumoral administration may move to alternative delivery routes for the optional infusions.
Arm II (dual delivery Tcm enriched)	Experimental	Biological: HER2(EQ)BBζ/CD19t+ T cells, Other: Laboratory Biomarker Analysis, Procedure: LeukapheresisPatients receive autologous HER2(EQ)BBzeta/CD19t+ Tcm cells via intratumoral/intracavitary catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites).
ARM III (dual delivery Tn/mem enriched)	Experimental	Biological: HER2(EQ)BBζ/CD19t+ T cells, Other: Laboratory Biomarker Analysis, Procedure: LeukapheresisPatients receive autologous HER2(EQ)BBzeta/CD19t+ Tn/mem cells via intratumoral/intracavitary catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (34 listed)

Participant has a prior histologically-confirmed diagnosis of a grade III or IV glioma, or has a prior histologically-confirmed diagnosis of a grade II glioma and now has radiographic progression consistent with a grade III or IV malignant glioma (MG)
Karnofsky performance status (KPS) >= 60%
Life expectancy > 4 weeks
The effects of HER2(EQBBzeta/CD19t+ T cells on the developing fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
City of Hope (COH) Clinical Pathology confirms HER2+ tumor expression by immunohistochemistry (>= 20%, 1+)

Key exclusion criteria (11 listed)

Research participant requires supplemental oxygen to keep saturation greater than 95% and the situation is not expected to resolve within 2 weeks
Research participants with a known history of congestive heart failure (CHF) or cardiac symptoms consistent with New York Heart Association (NYHA) classification III-IV within 6 months prior to Day 1 of protocol treatment, cardiomyopathy, myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications or with clinical history suggestive of the above must have an electrocardiogram (EKG) and echocardiogram (ECHO) performed within 42 days prior to registration and as clinically indicated while on treatment
Research participants with new symptoms of CHF, cardiomyopathy, myocarditis, MI, or exposure to cardiotoxic medications must have a cardiac consultation, creatinine phosphokinase (CPK), and troponin testing at pre -study and as clinically indicated
Research participant requires dialysis
Research participant has uncontrolled seizure activity and/or clinically evident progressive encephalopathy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HER2(EQ)BBζ/CD19t+ T cellsGiven via catheter	Biological	ARM III (dual delivery Tn/mem enriched), Arm I (intratumoral/intracavitary delivery), Arm II (dual delivery Tcm enriched)
Laboratory Biomarker AnalysisCorrelative studies	Other	ARM III (dual delivery Tn/mem enriched), Arm I (intratumoral/intracavitary delivery), Arm II (dual delivery Tcm enriched)
LeukapheresisAlso: Leukocytopheresis, Therapeutic LeukopheresisUndergo leukapheresis	Procedure or surgery	ARM III (dual delivery Tn/mem enriched), Arm I (intratumoral/intracavitary delivery), Arm II (dual delivery Tcm enriched)

Primary outcome

Incidence of grade 3 adverse events
Time frame: Up to 3 years
Tables will be created to summarize all toxicities and side effects by dose, time post treatment, organ, severity and arm.
Dose limiting toxicities (DLT)
Time frame: Up to 3 years
Rate and associated 90% Clopper and Pearson binomial confidence limits (90% confidence interval [CI]) will be estimated for participants' experiencing DLTs at the recommended phase 2 dose (RP2D) schedule.
Incidence of adverse events
Time frame: Up to 3 years
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Tables will be created to summarize all toxicities and side effects by dose, time post treatment, organ, severity and arm.

7 secondary outcomes

Chimeric antigen receptor (CAR) T cells detected in tumor cyst fluid, peripheral blood, and cerebrospinal fluid (CSF)
Time frame: Up to 3 years
Tumor cyst fluid, peripheral blood, and cerebrospinal fluid (CSF) cytokine levels
Time frame: Up to 3 years
Progression free survival
Time frame: At 6 months
Overall Survival (OS)
Time frame: At 6 months
Disease response
Time frame: Up to 3 years
Chimeric antigen receptor (CAR) T cells detected in tumor tissue
Time frame: Up to 3 years
HER2 antigen expression levels in tumor tissue
Time frame: Up to 3 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Behnam Badie principal investigator

City of Hope Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of grade 3 adverse events (time frame: Up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03389230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.