MASCT-I Combined With Apatinib and/or Camrelizumab in the Treatment of Bone and Soft Tissue Sarcoma

Sponsor
HRYZ Biotech Co.
Study ID
NCT04074564
Phase
EARLY_PHASE1
Status
Unknown

Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
14 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • MASCT-I, Camrelizumab,Apatinib — COMBINATION_PRODUCT
    Multi-Antigen Stimulated Cell Therapy-I Injection (MASCT-I) is a sequential immune cell therapy. Camrelizumab is an immune checkpoint inhibitors against PD-1. Apatinib is a highly selective tyrosine kinase inhibitor targeting VEGFR2.

Study Details

This study will evaluate the safety and preliminary efficacy of Multi-Antigen Stimulated Cell Therapy-I Injection (MASCT-I) in combination with Apatinib and/or Camrelizumab in patients with advanced bone and soft-tissue sarcoma.

Key Dates

Start date
Nov 22, 2019
Status verified
Oct 2023
Primary completion
Aug 7, 2024
Completion
Dec 5, 2024

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    Subgroup 1: MASCT-I A+Camrelizumab+Apatinib combination therapy; Subgroup 2: MASCT-I B+Camrelizumab+Apatinib combination therapy
  • Experimental: Part B
    MASCT-I (based on the administration schedule selected from part A) in combination with Apatinib

Primary Outcome Measure

Adverse events and serious adverse events (safety) [ Time Frame: 4 years ]

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