B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT04897321
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Adrenocortical Cancer
  • Carcinoma
  • Clear Cell Sarcoma
  • Desmoplastic Small Round Cell Tumor
  • Ewing Sarcoma
  • Germ Cell Cancer
  • Hepatoblastoma
  • Malignant Peripheral Nerve Sheath Tumors
  • Melanoma
  • Neuroblastoma
  • Osteosarcoma
  • Pediatric Solid Tumor
  • Rhabdoid Tumor
  • Rhabdomyosarcoma
  • Soft Tissue Sarcoma
  • Wilms Tumor

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis. Intravenous
  • Cyclophosphamide — DRUG
    Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA. Intravenous
  • MESNA — DRUG
    Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide
  • B7-H3 CAR T cells — DRUG
    The study participant will receive B7-H3-CAR T cells by vein, through either an IV or a central line.

Study Details

3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors. Primary objective To determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent/refractory B7-H3+ solid tumors after lymphodepleting chemotherapy Secondary objective To evaluate the antitumor activity of B7-H3-CAR T cells Exploratory objectives * To evaluate the tumor environment after treatment with B7-H3-CAR T cells * To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells

Key Dates

Start date
Jul 6, 2022
Status verified
May 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2028

Study Design

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

Arms

  • Other: Treatment Phase
    During the treatment phase, the participant receives an infusion of the B7-H3-CAR T cells that were made in the Collection and Manufacturing Phase. Chemotherapy is given for several days prior to the cellular infusion. Patients are then monitored for possible side effects, as well as effects of the treatment on their cancer.

Primary Outcome Measure

Safety of B7-H3-CAR T cells [ Time Frame: 6 weeks after B7-H3-CAR T cell infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Chris DeRenzo, MD
[email protected]
888-226-4343
Chris DeRenzo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Memphis, TN

By condition
MelanomaNeuroblastoma
By specialty
OncologySkin cancerDermatologyPediatric oncology
By research site
St. Jude Children's Research Hospital· Memphis, TN

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