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IM83 Clinical Study of CAR-T Cell Therapy in Patients With Relapsed or Refractory Osteosarcoma

NCT06412458 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-05-14

No results posted yet for this study

Summary

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

Conditions

  • Refractory Osteosarcoma
  • Recurrent Osteosarcoma

Interventions

BIOLOGICAL

IM83 CAR-T Cells

IM83 CAR-T Cells, 5×10\^8 cells, 1×10\^9 cells, and 2×10\^9 cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D- 3), determined by tumor burden at baseline. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Beijing Immunochina Medical Science & Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yu Zhang, PhD · Guangdong Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2025-06-15
Completion
2026-06-15

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06412458 on ClinicalTrials.gov