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Clinical Trial NCT07211737 for Relapsed Neuroblastoma, Refractory Neuroblastoma, Relapsed Osteosarcoma, Refractory Osteosarcoma is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Baylor College of MedicineNKG2D.Zeta-NK Cell Conditioning With C7R.GD2.CAR-T Cells for Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma Phase 1 27
Patients eligible for this study have neuroblastoma or osteosarcoma that expresses a substance on the cancer cells called GD2. This cancer has either come back after t...
Show More(INCITE-ON) Phase I Study of i15.NKG2D.Zeta-NK Cell Conditioning in the Tumor Micro-environment in Combination With C7R.GD2.CAR-T for the Treatment of Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma
- H-55743 INCITE-ON
CAR T cells
Neuroblastoma
Osteosarcoma
Immunotherapy
chimeric antigen receptor
NK Cell
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentali15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells Three dose levels will be evaluated. This is a dose escalating trial which will infuse doses of i15.NKG2D.zeta NK cells followed by a fixed dose of C7R.GD2.CAR T cells 5 days later. | i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells Dose Level 1: 3 x 10\^8/m\^2 of i15.NKG2D.zeta NK cells and 3 x 10\^7/m\^2 of C7R.GD2.CAR T cells given 5 days later. i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells Dose Level 2: 6 x 10\^8/m\^2 of i15.NKG2D.zeta NK cells and 3 x 10\^7 cells/m\^2 of C7R.GD2.CAR T cells given 5 days later. i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells Dose Level 3: 12 x 10\^8/m\^2 of i15.NKG2D.zeta NK cells and 3 x 10\^7 cells/m\^2 of C7R.GD2.CAR T cells given 5 days later. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Dose-limiting toxicity (DLT) rate | Proportion of participants with DLTs related to the combination of NK cell and T cell infusions evaluated as per the NCI CTCAE v5.0 criteria | 4 weeks post-CAR-T cell infusion |
Maximum tolerated dose (MTD) of i15.NKG2D.zeta-NK cells when given in combination with C7R.GD2.CAR-T cells | The dose level of infused NK cells for which the DLT rate is approximately 0.3 | 4 weeks post CAR-T infusion of the last participant |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective response rate (ORR) | Proportion of participants with complete response (CR) or partial response (PR) according to RECIST v1.1 criteria and/or MIBG evaluation (for neuroblastoma) | 6 weeks after CAR-T infusion |
Cytokine release syndrome (CRS) grade | Any grade CRS as evaluated by established clinical CRS Grading Scale | 4 weeks post CAR-T infusion |
PROCUREMENT INCLUSION:
Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease.
Or
Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease.
Karnofsky/Lansky score of 60% or greater.
Informed consent and assent (as applicable) obtained from parent/guardian and child.
Greater than 1 year of age.
PROCUREMENT EXCLUSION:
- History of hypersensitivity to murine protein-containing products.
- Known presence of Human Anti-Mouse Antibodies (HAMA).
- Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months).
- Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).
TREATMENT INCLUSION:
Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease.
Or
Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease.
Karnofsky/Lansky score of 50% or greater
Pulse Ox greater than or equal to 90% on room air
AST less than 5 times upper limit of normal (less than 10 times upper normal if known with metastatic liver disease)
Total bilirubin less than 3 times the upper limit of normal
Serum creatinine less than 3 times upper limit of normal
Available autologous T-cells with greater than or equal to 20% expressing GD2.CAR
Informed consent and assent (as applicable) obtained from parent/guardian and child.
Greater than 1 year of age.
Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study.
TREATMENT EXCLUSION:
- History of hypersensitivity to murine protein containing products (patients who have undergone desensitization and successful re-challenge without hypersensitivity reaction are eligible).
- Known presence of Human Anti-Mouse Antibodies (HAMA).
- Tumor potentially causing airway obstruction per investigator discretion.
- Pregnancy or lactation / will not use birth control methods.
- Currently receiving immunosuppressive drugs (patients on low dose corticosteroids are eligible: less than 0.25 mg/kg/day of prednisone/equivalent).
- Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).
Baylor College of Medicine289 active studies to exploreCenter for Cell and Gene Therapy, Baylor College of MedicineTexas