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CAR T-cell Therapy

CARv3-TEAM-E T cells for Glioblastoma

Massachusetts General Hospital Cancer Center, Boston, MA
Targeting 4 different conditionsCARv3-TEAM-E T cellsPhase 1RecruitingLed by William Curry, MDResearch Sponsored by Marcela V. Maus, M.D.,Ph.D.

Study Summary

This trial seeks to find the best dose of CARv3-TEAM-E T Cells to treat glioblastoma, a type of brain cancer.

Eligible Conditions
  • Glioblastoma
  • Malignant Glioma
  • Brain Tumor

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You need to be able to have a special type of body scan called an MRI with a special dye.
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You have a type of brain cancer called recurrent GBM with a specific mutation called EGFRvIII.
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You are planning to receive radiation therapy without also taking temozolomide at the same time or afterwards.
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You have a type of brain tumor called recurrent GBM, but you do not have a specific gene mutation called EGFRvIII.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~registration to 2 years post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and registration to 2 years post-treatment for reporting.

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 (AEs)
Number of Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Overall Response Rate
Overall Survival Rate
Progression Free Survival (PFS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Safety Run-In PhaseExperimental Treatment1 Intervention
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.
Group II: Arm 3: Recurrent GBM, EGFRvIII NegativeExperimental Treatment1 Intervention
Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw. CARv3-TEAM-E will be administered 1x weekly for 6 doses on Days 0, 7, 14, 21, 28, and 36. Participants will be followed for 2 years post-treatment.
Group III: Arm 2: Newly Diagnosed GBM, EGFRvIII PositiveExperimental Treatment1 Intervention
Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw. CARv3-TEAM-E will be administered 1x weekly for 6 doses on Days 0, 7, 14, 21, 28, and 36. Participants will be followed for 2 years post-treatment.
Group IV: Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII PositiveExperimental Treatment1 Intervention
Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw. CARv3-TEAM-E will be administered 1x weekly for 6 doses on Days 0, 7, 14, 21, 28, and 36. Participants will be followed for 2 years post-treatment.

Find a Location

Who is running the clinical trial?

Marcela V. Maus, M.D.,Ph.D.Lead Sponsor
4 Previous Clinical Trials
75 Total Patients Enrolled
William Curry, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Glioblastoma
18 Patients Enrolled for Glioblastoma

Media Library

CARv3-TEAM-E T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05660369 — Phase 1
Glioblastoma Research Study Groups: Safety Run-In Phase, Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII Positive, Arm 2: Newly Diagnosed GBM, EGFRvIII Positive, Arm 3: Recurrent GBM, EGFRvIII Negative
Glioblastoma Clinical Trial 2023: CARv3-TEAM-E T Cells Highlights & Side Effects. Trial Name: NCT05660369 — Phase 1
CARv3-TEAM-E T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05660369 — Phase 1

Frequently Asked Questions

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

What risks would participants in a Safety Run-In Phase be exposed to?

"As this is the first clinical trial of its kind, it was assigned a safety rating of 1. This reflects that there has been limited research into both the efficacy and security profile of Safety Run-In Phase."

Answered by AI

Are there opportunities for volunteer participants in this research effort?

"According to clinicaltrials.gov, this medical research is no longer actively recruiting participants as it was last edited on December 13th 2022. Despite that fact, there are still 1,612 other studies seeking volunteers at the present time."

Answered by AI

What key goals are being pursued with this research endeavor?

"This trial seeks to evaluate the number of Dose-Limiting Toxicities (DLTs) over two years. Secondary endpoints include Overall Response Rate, assessed using RANO Criteria; Overall Survival rate; and Progression Free Survival rates."

Answered by AI
~14 spots leftby Jun 2025