Loc3CAR is a phase 1 clinical trial evaluating the safety and efficacy of autologous B7-H3–specific CAR T–cell therapy for children and young adults with relapsed or refractory brain tumors, or for patients with diffuse intrinsic pontine glioma who have undergone upfront radiation therapy.
Treatment includes 6 B7-H3 CAR T–cell infusions over 8 weeks.
B7-H3 CAR T cells will be locoregionally administered via a CNS reservoir catheter without lymphodepletion chemotherapy.
The study will evaluate the safety and maximum tolerated dose of B7-H3 CAR T cells for 8 weeks. The study will last 1 year, after which patients will enroll in our existing institutional long-term follow-up protocol.
To find the highest dose of B7-H3 CAR T cells that is safe to give patients with primary brain tumors
Inclusion criteria include:
- Up to 21 years old
- Primary CNS tumor that meets criteria for either cohort A or B:
- Cohort A: B7-H3–positive relapsed or refractory non-brainstem primary CNS tumor
- Cohort B: Brainstem high-grade neoplasm
Exclusion criteria include:
- Other clinically significant medical disorders such as serious infections or significant cardiac, pulmonary, hepatic, psychiatric, or other organ dysfunction
St. Jude Children’s Research Hospital, Memphis, Tennessee
About this study
New treatments are needed to help children and young adults whose brain cancers return or are hard to treat. CAR T–cell therapy is a type of immunotherapy where the body’s T cells are changed in the lab so that they can attack cancer cells. Loc3CAR is a study that uses CAR T cells to treat children and young adults with brain tumors that have returned or are hard to treat. The changed T cells (Loc3CAR) recognize a protein called B7-H3, found in many childhood brain tumors.
In this study, we will collect white blood cells (T cells) from the patient. We will change those cells in the lab to make the Loc3CAR cells. The Loc3CAR cells are returned to the patient so they can attack the tumors with a specific type of protein called B7-H3. The Loc3CAR cells are given using a small, flexible tube (catheter) that enters the brain and delivers the cells. An IV is not used.
Purpose of this clinical trial
The purpose of this study is to find:
- The largest dose of Loc3CAR T cells that is safe to give patients with B7-H3–positive brain tumors
- The side effects of Loc3CAR T cells
- The effect Loc3CAR T cells have on brain tumors
This trial will help scientists better understand how the immune system fights this kind of tumor. What we learn from this study could help us create better treatments.
To take part in this study, you must:
- Have a tumor that is positive for B7-H3
- Be 21 years old or younger
Patients must stay in Memphis while getting CAR T cells.
Loc3CAR Sponsors: St. Jude Children’s Research Hospital ClinicalTrials.gov identifier NCT05835687 Trial Start Date: April 2023 Estimated Enrollment: 36 Study Phase: Phase 1 Conditions: Relapsed/refractory brain tumors, high-grade brainstem neoplasms, DIPG Ages: 21 years or younger Principal investigators: Christopher DeRenzo, MD; Kelsey Bertrand, MBBS; Giedre Krenciute, PhD Study Sites: St. Jude Children’s Research Hospital For a consultation or to discuss St. Jude Physician/Patient Referral Office
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Memphis, TN 38105 USA
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