About this trial
This study is being conducted in patients with GPC3-positive brain tumors that have recurred or have not responded to standard therapy. Atypical teratoid rhabdoid tumors (ATRT) are aggressive tumors with poor outcomes and limited treatment options, particularly in young children. There is a need for new therapies that can improve outcomes while minimizing toxicity.
This study evaluates a new experimental treatment using genetically engineered T cells (RADIANT-T cells) that target glypican-3 (GPC3), a protein expressed on tumor cells. These T cells are modified to express a chimeric antigen receptor (CAR) targeting GPC3, along with IL-15 and IL-21 to enhance their persistence and activity. The cells also include an inducible safety mechanism (iCasp9) that allows them to be eliminated if necessary.
The purpose of this study is to determine the highest safe dose of RADIANT-T cells, evaluate their safety and side effects, assess how long they persist in the body, and determine whether they show anti-tumor activity in patients with GPC3-positive brain tumors.
Eligibility criteria
Qualifiers
1) Diagnosis of GPC3-positive recurrent ATRT.
2) Age ≥ 6 months
3) Karnofsky/Lansky score ≥ 60%
4) Informed consent explained to, understood by, and signed by patient/guardian; copy provided
Disqualifiers
1) No history of organ transplantation
2) No known HIV positivity
3) No active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)
4) No other risk factors in which administration of the investigational agent is deemed not in the patient's best interest, in the opinion of the investigator
Trial design
Treatments tested in this trial
- 21.15.GPC3-CAR T Cells