GlioblastomaPhase 1NCT05660369
CARv3-TEAM-E T Cells in Glioblastoma
A Phase 1 study testing CARv3-TEAM-E T cells in people with Glioblastoma and Malignant Glioma, run by Marcela V. Maus, M.D.,Ph.D. at 1 site in United States.
Trial summary
The goal of this research study is to determine the best dose of CARv3-TEAM-E T Cells for treating participants with glioblastoma. The name of the treatment intervention used in this research study is: -CARv3-TEAM-E T Cells (or Autologous T lymphocytes). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Malignant Glioma, Recurrent Glioblastoma
- What is being tested?
- CARv3-TEAM-E T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2023to 1 Sep 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Safety Run In Arm and ARM 1: Recurrent GBM, EGFRvIII mutant
- Participants must have histologically confirmed recurrent GBM or molecular features of GBM with presence of EGFRvIII mutation detected at initial diagnosis. MGMT methylated, unmethylated, or unknown is allowed.
- Participants must be at first progression or recurrence and plan is for biopsy or surgical debulking. Participants must have at least received prior radiation. Prior temozolomide is not required if the participant is MGMT unmethylated.
- Participants must be 2 weeks from prior alkylating therapy or immunotherapy and ≥ 5 half-lives from another investigational agent before proceeding with collection or treatment. No washout is required from radiation since participants will need histological confirmation of recurrence to participate.
- ARM 2: Newly Diagnosed GBM, EGFRvIII mutant (will only open once safety is confirmed in Arms 1 and 3)
- Participants must have histologically confirmed newly diagnosed GBM with presence of EGFRvIII mutation and their tumors must be MGMT unmethylated.
Show all 39Show fewer
- Treatment planned with involved field radiation alone without concomitant or sequential temozolomide.
- ARM 3: Recurrent GBM, EGFRvIII negative
- Participants must have histologically confirmed recurrent GBM with EGFR amplification but no EGFRvIII mutation based on initial diagnostic tissue.
- Participants must be at first recurrence and plan is for biopsy or surgical debulking. Participants must have at least received prior radiation. Prior temozolomide is not required if the participant is MGMT unmethylated.
- Participants must be 2 weeks from prior alkylating therapy or immunotherapy and ≥ 5 half-lives from another investigational agent. No washout is required from radiation since participants will need histological confirmation of recurrence to participate.
- ARM 1: Recurrent GBM, EGFRvIII mutant and ARM 3: Recurrent GBM, EGFRvIII negative:
- Must be at least 3 months from completion of radiation or evidence of progression is outside the high dose radiation field.
- Safety Run-In Arm and ARM 1: Recurrent GBM, EGFRvIII mutant and ARM 3: Recurrent GBM, EGFRvIII negative:
- Participants must have measurable disease, defined as at least one lesion ≥10 mm (≥1 cm) with MRI. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.
- ALL ARMS:
- Patients cannot have posterior fossa or intramedullary spine-only disease. Leptomeningeal disease is allowed anywhere in the neuroaxis. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.
- Resolution of AEs from any prior systemic anticancer therapy or radiotherapy to Grade 1 or baseline (except Grade 2 alopecia and Grade 2 sensory neuropathy)
- Medically able and willing to undergo placement of an Ommaya reservoir.
- Steroid dose anticipated to be ≤ 4 mg of dexamethasone a day or equivalent at time of first CAR-v3-TEAM-E infusion.
- Age ≥18 years
- Karnofsky ≥60%
- Must be able to undergo an MRI with contrast.
- Life expectancy of greater than 3 months.
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥1,000/mcL
- Platelets ≥80,000/mcL
- Total bilirubin ≤ institutional upper limit of normal (ULN); For patients with Gilbert's syndrome, total bilirubin can be ≤ 3xULN.
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- CrCl ≥ 60 mL/min
- Participant has no prior history of malignancy, unless the subject has been free of the disease for ≥5 years with the exception of the following noninvasive malignancies:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (T1a or T1b) or prostate cancer that is curative
- Left ventricular ejection fraction >50% as determined by TTE.
- The effects of CARv3-TEAM-E on the developing human 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; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CARv3-TEAM-E administration.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Intraparenchymal posterior fossa disease
- Intramedullary spinal disease as the only site of disease.
- Prior EGFRvIII targeted therapies.
- Prior bevacizumab treatment.
- Treatment with an any prior gene-therapy or gene-modified cellular therapy.
- Patients with a VP shunt or patients needing a shunt in the immediate future are excluded from participating
Show all 19Show fewer
- Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CARv3-TEAM-E (ex. cetuximab).
- Participants with uncontrolled intercurrent illness.
- Human immunodeficiency virus (HIV)-infected participants are not eligible.
- Participants with evidence of chronic hepatitis B virus (HBV) infection or active hepatitis C virus (HCV) infection are not eligible.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CARv3-TEAM-E , breastfeeding should be discontinued if the mother is treated with CARv3-TEAM-E.
- For Arm 2, prior to CARv3-TEAM-E Infusion, the following criteria should be confirmed in addition to the relevant criteria above:
- Participants must have completed 75% of the planned 6 weeks of involved field radiation without temozolomide
- Tumor location and size criteria as in 3.1.7 above.
- Prior cancer directed therapy other than radiation is not allowed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
William Curry, MD, 617-724-6226, carteamingbm@mgb.org
About this study
Official title: INCIPIENT: INtraventricular CARv3-TEAM-E T Cells for PatIENTs With GBM
The goal of this research study is to determine the best dose of CARv3-TEAM-E T Cells for treating participants with glioblastoma.
The name of the treatment intervention used in this research study is:
-CARv3-TEAM-E T Cells (or Autologous T lymphocytes).
Read the detailed description
This is a non-randomized, open label, single site Phase 1 study to define the appropriate dose of CARv3-TEAM-E and evaluate its safety for the treatment of recurrent or newly diagnosed glioblastoma.
The U.S. Food and Drug Administration (FDA) has not approved CARv3-TEAM-E T Cells as a treatment for any disease. This is the first time that CARv3-TEAM-E T Cells will be given to humans. CARv3-TEAM-E T Cells are made from a person's own collected immune cells (T-Cells) that are genetically changed and then delivered back into the body to try to kill their cancerous cells.
The research study procedures include screening for eligibility, study treatment, including evaluations and follow up visits, blood collections, echocardiograms, and radiologic imaging of tumors.
It is expected participants will receive treatment over a period of short-term (approx. 2 years) and then long-term follow-up of up to 15 years.
It is expected that about 21 people will take part in this research study.
This research study has received funding through an internal grant program.
- Being tested
- CARv3-TEAM-E T cells
- Keywords
- Glioblastoma, Malignant Glioma, Recurrent Glioblastoma, Recurrent Glioma, Immunotherapy, Gene-Transfer Therapy
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARv3-TEAM-E T cellsDrug
Also called Autologous T lymphocyte
Autologous T lymphocyte population that contains cells transduced ex-vivo with a CARv3-TEAM-E lentiviral vector encoding a chimeric antigen receptor (CAR). Administered via Ommaya reservoir.
| Study group | Role | What they receive |
|---|---|---|
| Safety Run-In Phase | Experimental | * Participant enrollment will be staggered by 30 days for up to 3 participants.
* Participants will receive 1 infusion of CARv3-TEAM-E.
* Phase will be expanded up to 6 participants if any Dose-Limiting Toxicities DLTs occur.
* After all participants have been enrolled, there will be an evaluation made by the Data Safety Monitoring Board (DSMB) and the FDA to determine the safety of enrollment into additional arms. Receives: Drug: CARv3-TEAM-E T cells |
| Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII Positive | Experimental | * Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw.
* Rituximab will be administered 5-10 days prior to infusion.
* Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion.
* CARv3-TEAM-E will be administered via Ommaya on D0
* Participants will be followed for 2 years post-treatment.
* Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses. Receives: Drug: CARv3-TEAM-E T cells |
| Arm 2: Newly Diagnosed GBM, EGFRvIII Positive | Experimental | * Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw.
* Rituximab will be administered 5-10 days prior to infusion.
* Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion.
* CARv3-TEAM-E will be administered via Ommaya on D0
* Participants will be followed for 2 years post-treatment.
* Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses. Receives: Drug: CARv3-TEAM-E T cells |
| Arm 3: Recurrent GBM, EGFRvIII Negative | Experimental | * Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw.
* Rituximab will be administered 5-10 days prior to infusion.
* Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion.
* CARv3-TEAM-E will be administered via Ommaya on D0
* Participants will be followed for 2 years post-treatment.
* Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses. Receives: Drug: CARv3-TEAM-E T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Defined as the incidence of ≥ Grade 3-4 adverse events related to CARv3-TEAM-E.
Measured: From Day 0 to 2 years post-treatment
Number of Dose-Limiting Toxicities (DLTs)
Defined as any related toxicity experienced by run-in cohort of CTCAE v5 grade ≥ 4 Adverse Event
Measured: up to 6 months
Secondary outcomes (4)
Proportion of Participants with One Infusion
The study will be deemed feasible if the proportion of participants enrolled that go on to receive at least one infusion of CARv3-TEAM-E cells is 60% or greater. Applies to participants in run-in cohort and Arms 1 and 3.
Measured: up to 6 months
Overall Response Rate
Defined as the best response recorded from the start of treatment until disease progression/recurrence and evaluated using the Response Assessment in Neuro-Oncology Criteria (RANO).
Measured: Day 0 to 2 years post-treatment
Overall Survival Rate
Defined as the time from registration to death due to any cause.
Measured: From Day 0 to 2 years post-treatment
Progression Free Survival (PFS)
Defined as the time from registration to the earlier of progression or death due to any cause.
Measured: Registration to 2 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start22 Mar 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marcela V. Maus, M.D.,Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcela V. Maus, M.D.,Ph.D., Massachusetts General Hospital
- Investigators
- William Curry, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660369
- Sponsor's protocol ID
- 22-175
- Status last verified
- Jul 2026
- First submitted
- 13 Dec 2022
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Choi BD, Gerstner ER, Frigault MJ, Leick MB, Mount CW, Balaj L, Nikiforow S, Carter BS, Curry WT, Gallagher K, Maus MV. Intraventricular CARv3-TEAM-E T Cells in Recurrent Glioblastoma. N Engl J Med. 2024 Apr 11;390(14):1290-1298. doi: 10.1056/NEJMoa2314390. Epub 2024 Mar 13.
PubMed 38477966
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INCIPIENT: INtraventricular CARv3-TEAM-E T Cells for PatIENTs With GBM
- ClinicalTrials.gov ID
- NCT05660369
- Acronym / sponsor ID
- 22-175
- Keywords
- Glioblastoma, Malignant Glioma, Recurrent Glioblastoma, Recurrent Glioma, Immunotherapy, Gene-Transfer Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Marcela V. Maus, M.D.,Ph.D.University, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Dec 2022 (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.
The goal of this research study is to determine the best dose of CARv3-TEAM-E T Cells for treating participants with glioblastoma.
The name of the treatment intervention used in this research study is:
-CARv3-TEAM-E T Cells (or Autologous T lymphocytes).
Detailed description
This is a non-randomized, open label, single site Phase 1 study to define the appropriate dose of CARv3-TEAM-E and evaluate its safety for the treatment of recurrent or newly diagnosed glioblastoma.
The U.S. Food and Drug Administration (FDA) has not approved CARv3-TEAM-E T Cells as a treatment for any disease. This is the first time that CARv3-TEAM-E T Cells will be given to humans. CARv3-TEAM-E T Cells are made from a person's own collected immune cells (T-Cells) that are genetically changed and then delivered back into the body to try to kill their cancerous cells.
The research study procedures include screening for eligibility, study treatment, including evaluations and follow up visits, blood collections, echocardiograms, and radiologic imaging of tumors.
It is expected participants will receive treatment over a period of short-term (approx. 2 years) and then long-term follow-up of up to 15 years.
It is expected that about 21 people will take part in this research study.
This research study has received funding through an internal grant program.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Safety Run-In Phase | Experimental | Drug: CARv3-TEAM-E T cells* Participant enrollment will be staggered by 30 days for up to 3 participants. * Participants will receive 1 infusion of CARv3-TEAM-E. * Phase will be expanded up to 6 participants if any Dose-Limiting Toxicities DLTs occur. * After all participants have been enrolled, there will be an evaluation made by the Data Safety Monitoring Board (DSMB) and the FDA to determine the safety of enrollment into additional arms. |
| Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII Positive | Experimental | Drug: CARv3-TEAM-E T cells* Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw. * Rituximab will be administered 5-10 days prior to infusion. * Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion. * CARv3-TEAM-E will be administered via Ommaya on D0 * Participants will be followed for 2 years post-treatment. * Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses. |
| Arm 2: Newly Diagnosed GBM, EGFRvIII Positive | Experimental | Drug: CARv3-TEAM-E T cells* Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw. * Rituximab will be administered 5-10 days prior to infusion. * Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion. * CARv3-TEAM-E will be administered via Ommaya on D0 * Participants will be followed for 2 years post-treatment. * Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses. |
| Arm 3: Recurrent GBM, EGFRvIII Negative | Experimental | Drug: CARv3-TEAM-E T cells* Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw. * Rituximab will be administered 5-10 days prior to infusion. * Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion. * CARv3-TEAM-E will be administered via Ommaya on D0 * Participants will be followed for 2 years post-treatment. * Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Safety Run In Arm and ARM 1: Recurrent GBM, EGFRvIII mutant
- Participants must be 2 weeks from prior alkylating therapy or immunotherapy and ≥ 5 half-lives from another investigational agent before proceeding with collection or treatment. No washout is required from radiation since participants will need histological confirmation of recurrence to participate.
- ARM 2: Newly Diagnosed GBM, EGFRvIII mutant (will only open once safety is confirmed in Arms 1 and 3)
- ARM 3: Recurrent GBM, EGFRvIII negative
- Participants must be 2 weeks from prior alkylating therapy or immunotherapy and ≥ 5 half-lives from another investigational agent. No washout is required from radiation since participants will need histological confirmation of recurrence to participate.
Key exclusion criteria (19 listed)
- Intraparenchymal posterior fossa disease
- Intramedullary spinal disease as the only site of disease.
- Prior EGFRvIII targeted therapies.
- Prior bevacizumab treatment.
- Treatment with an any prior gene-therapy or gene-modified cellular therapy.
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 |
|---|---|---|
| CARv3-TEAM-E T cellsAlso: Autologous T lymphocyteAutologous T lymphocyte population that contains cells transduced ex-vivo with a CARv3-TEAM-E lentiviral vector encoding a chimeric antigen receptor (CAR). Administered via Ommaya reservoir. | Drug | Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII Positive, Arm 2: Newly Diagnosed GBM, EGFRvIII Positive, Arm 3: Recurrent GBM, EGFRvIII Negative, Safety Run-In Phase |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: From Day 0 to 2 years post-treatment
Defined as the incidence of ≥ Grade 3-4 adverse events related to CARv3-TEAM-E.
Number of Dose-Limiting Toxicities (DLTs)
Time frame: up to 6 months
Defined as any related toxicity experienced by run-in cohort of CTCAE v5 grade ≥ 4 Adverse Event
4 secondary outcomes
Proportion of Participants with One Infusion
Time frame: up to 6 months
Overall Response Rate
Time frame: Day 0 to 2 years post-treatment
Overall Survival Rate
Time frame: From Day 0 to 2 years post-treatment
Progression Free Survival (PFS)
Time frame: Registration to 2 years post-treatment
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 14 Jul 2026.
- Derived from this study: PubMed 38477966Choi BD, Gerstner ER, Frigault MJ, Leick MB, Mount CW, Balaj L, Nikiforow S, Carter BS, Curry WT, Gallagher K, Maus MV. Intraventricular CARv3-TEAM-E T Cells in Recurrent Glioblastoma. N Engl J Med. 2024 Apr 11;390(14):1290-1298. doi: 10.1056/NEJMoa2314390. Epub 2024 Mar 13.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
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.
William Curry, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CARv3-TEAM-E T cells in people with Glioblastoma and Malignant Glioma, run by Marcela V. Maus, M.D.,Ph.D. at 1 site in United States.
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 39 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 14 Jul 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?
Contact William Curry, MD (617-724-6226, carteamingbm@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: From Day 0 to 2 years post-treatment). The study lists 2 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 NCT05660369, which also lists 1 linked publication.
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 14 Jul 2026.