Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed /Refractory Neuroblastoma or Refractory/ Relapsed Osteosarcoma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05400603
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ex Vivo Expanded Allogeneic γδ T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and Zoledronate — COMBINATION_PRODUCT
    The cell dose will be based on the subject's body weight. Subjects will receive a single infusion of third party, ex vivo expanded, frozen then thawed γδ T cell product at a dose of 3 x 106 cells/kg on Day 6 and then if they meet criteria for subsequent γδ T cell dose will receive a second dose of 3 x 106 cells/kg on Day 13. The dose will be escalated to 1 x 10\^7 and then 3 x 10\^7 cells/kg. In absence of any dose limiting toxicity, 3 x 10\^7 cells/kg will be accepted as the maximal dose. Dinutuximab (17.5 mg/m2), temozolomide (100 mg/m2),irinotecan (50 mg/m2) and zoledronic acid (0.0125 mg/kg/dose) will be consistent across all dose levels. Max γδ T cell dose will not exceed Level 3 dosing at 50 kg: 1.5×10⁹ total γδ T cells.

Study Details

The goal of this clinical trial is to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate in children with refractory or recurrent neuroblastoma or refractory/ relapsed osteosarcoma as well as to define the toxicities of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate

Key Dates

Start date
Nov 6, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Phase I cohort
    Subjects are assigned a cell therapy dose level at registration. Entry dose is Level 1, with escalation to Level 3 using a 3+3 design. If no progression, up to 4 courses may be given. Each course includes two γδ T cell infusions, one week apart. Toxicity for dose escalation and MTD will be assessed in Course 1. Disease response will be evaluated after Courses 2 and 4. Dinutuximab (17.5 mg/m²), temozolomide (100 mg/m²), irinotecan (50 mg/m²), and zoledronate (0.0125 mg/kg) are consistent across dose levels. Same γδ T cell donor will be used for both infusions per course. Due to stock supply, this may not always be possible. In each cohort, the first two subjects are staggered; the second is enrolled only after the first completes the DLT observation (≥21 days).

Primary Outcome Measure

Maximum Tolerated Dose/Recommended Phase 2 Dose of gamma delta T cells [ Time Frame: 21 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Healthcare of AtlantaAtlantaGeorgia30322
Kelly Goldsmith, MD
[email protected]

Find similar trials in Atlanta, GA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Children's Healthcare of Atlanta· Atlanta, GA

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