Recurrent Osteosarcoma Clinical Trial
Official title:
Phase I Clinical Study to Evaluate the Safety and Efficacy of IM83 CAR-T Cells for the Treatment of Relapsed or Refractory Osteosarcoma
The purpose of this study, a single-center, open, single-dose clinical study, was to evaluate the safety, tolerability, and pharmacokinetic profile of IM83 CAR-T cells in the treatment of patients with relapsed or refractory osteosarcoma
This study is planned to enroll 9-18 patients with relapsed or refractory osteosarcoma in a modified "3+3" design for dose escalation, with three dose groups of 5×10^8 cells, 1×10^9 cells, and 2×10^9 cells.3-6 subjects are planned to be enrolled in each dose group to assess their safety. Each dose group is planned to enroll 3-6 subjects to assess safety, and if the incidence of horizontal dose-limiting toxicity (DLT) is ≤1/6 within 28 days after transfusion in a dose group, the transfusion of cells from the next dose group can be initiated. This study will be divided into a screening period, a cell collection period, a chemotherapy pretreatment period, a return infusion and a follow-up period, and within 28 days of return infusion the investigator will assess whether a DLT (Dose limited toxicity) event has occurred to confirm the safety of this dose group. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06041490 -
Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation
|
Phase 2 | |
| Not yet recruiting |
NCT05515068 -
Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
|
||
| Completed |
NCT00093821 -
Tanespimycin in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03233204 -
Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
| Completed |
NCT01553539 -
Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery
|
Phase 2 | |
| Completed |
NCT00091182 -
Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
|
Phase 2 | |
| Completed |
NCT00004078 -
Irinotecan in Treating Children With Refractory Solid Tumors
|
Phase 2 | |
| Completed |
NCT00004241 -
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma
|
Phase 1 | |
| Active, not recruiting |
NCT04284774 -
Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial
|
Phase 2 | |
| Recruiting |
NCT04851119 -
Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03213678 -
Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
| Recruiting |
NCT04668300 -
Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma
|
Phase 2 | |
| Completed |
NCT02470091 -
Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma
|
Phase 2 | |
| Completed |
NCT01016015 -
Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma
|
Phase 2 | |
| Completed |
NCT01807052 -
Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas
|
N/A | |
| Active, not recruiting |
NCT03698994 -
Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
| Active, not recruiting |
NCT03213665 -
Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
| Not yet recruiting |
NCT03205644 -
VX15/2503 in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04320888 -
Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial
|
Phase 2 | |
| Completed |
NCT00030667 -
Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood
|
Phase 2 |