CAR T Cells After Lymphodepletion for the Treatment of IL13Rα2 Positive Recurrent or Refractory Brain Tumors in Children

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT04510051
Phase
PHASE1
Status
Recruiting
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Conditions

  • Malignant Brain Neoplasm
  • Recurrent Malignant Brain Neoplasm
  • Refractory Malignant Brain Neoplasm

Eligibility Criteria

Sex
ALL
Age
4 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine — DRUG
    Given IV
  • IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes — BIOLOGICAL
    Given intraventricularly

Study Details

This phase I trial investigates the side effects of chemotherapy and cellular immunotherapy in treating children with IL13Ralpha2 positive brain tumors that have come back after a period of improvement (recurrent) or do not respond to treatment (refractory). Cellular immunotherapy (IL13(EQ)BBzeta/CD19t+ T cells) are brain-tumor specific cells that may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many patients with brain tumor respond to treatment, but then the tumor starts to grow again. Giving chemotherapy in combination with cellular immunotherapy may kill more tumor cells and improve the outcome of treatment.

Key Dates

Start date
Dec 4, 2020
Status verified
Mar 2026
Primary completion
Feb 24, 2027
Completion
Feb 24, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (chemotherapy, IL13(EQ)BBzeta/CD19t+ T cells)
    Patients receive cyclophosphamide intravenously IV on days -5 and -4, and fludarabine IV on days -5 to -2. Patients then receive autologous IL13(EQ)BBzeta/CD19t+ T cells intraventricularly over 5 minutes QW on day 0. Treatment with autologous IL13(EQ)BBzeta/CD19t+ T cells repeats every 7 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles of IL13(EQ)BBzeta/CD19t+ T cells as long as they continue to meet eligibility criteria and have doses available for infusion.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 1 year after the last chimeric antigen response (CAR) T cell infusion ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Leo D. Wang
[email protected]
833-582-4673
Leo D. Wang (PRINCIPAL_INVESTIGATOR)
Children's Hospital Los AngelesLos AngelesCalifornia90027
Tom Belle Davidson, MD
[email protected]
323-361-8147
C.S. Mott Children's Hospital, University of MichiganAnn ArborMichigan48109
Santhosh Upadhyaya, MD
[email protected]
734-936-4000

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAChildren's Hospital Los Angeles· Los Angeles, CAC.S. Mott Children's Hospital, University of Michigan· Ann Arbor, MI

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