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

NCT04074564 | Unknown Early Phase 1 DMC

• 1 other identifier: MASCT-I-1005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoma

Keywords

MASCT-I; Cell-based immunotherapy; Camrelizumab; Apatinib; Tumor associated antigen

Outcome Measures

Primary Outcomes (1)

• Adverse events and serious adverse events (safety)

  All adverse events and serious adverse events during the study

  4 years

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  4 years

• Progression-Free Survival (PFS)

  4 years

• Disease Control Rate (DCR)

  4 years

• Overall Survival (OS)

  4 years

• immune response

  4 years

Study Arms (2)

Part A

EXPERIMENTAL

Subgroup 1: MASCT-I A+Camrelizumab+Apatinib combination therapy; Subgroup 2: MASCT-I B+Camrelizumab+Apatinib combination therapy

Combination Product: MASCT-I, Camrelizumab,Apatinib

Part B

EXPERIMENTAL

MASCT-I (based on the administration schedule selected from part A) in combination with Apatinib

Combination Product: MASCT-I, Camrelizumab,Apatinib

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.

Part A; Part B

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 14-70 years old.
• Obtain the written informed consent of the patient/legal representative;
• In patients with unresectable recurrent or metastatic advanced bone and soft tissue sarcoma, histologically or cytologically confirmed objective radiographic progression (RECIST 1.1) after first-line or further lines treatment, and the maximum diameter of metastatic lesions is ≤ 8 cm. When objective radiographic progression (RECIST 1.1) found in patients with alveolar soft-part sarcoma and clear cell sarcoma, even if they have not received first line or further lines treatment could also be included in this study;
• The interval between the last PD-1/PD-L1/CTLA-4 antibody treatment and enrollment was more than 4 weeks;
• At least one measurable and assessable lesion defined by RECIST 1.1;
• ECOG performance status of 0-1 (2 for amputees);
• Estimated life expectancy ≥ 6 months;
• At least 4 weeks after the last chemotherapy;
• Cardiopulmonary function is basically normal.
• Tumor tissue specimens could be provided for PDL1, MSI detection.
• Blood samples could be provided for immune response test.
• Patients with potential fertility need to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill or condom) during the study treatment period and within 6 months after the end of the study treatment period; The serum or urine HCG test must be negative within 72 hours before the study was included; And must be non lactating.
• Patients with organ function as defined below (any blood components and growth factors are not allowed within 14 days before screening):
• A) Hemoglobin ≥ 90g/L;
• B) Leukocyte ≥3.0 \*109/L;

You may not qualify if:

• Subjects have participated in another clinical study at the same time, observational studies are not included.
• Those who have received other systemic anti-tumor treatment.
• Pregnant or plan to get pregnant.
• Allergic to sodium citrate or human albumin.
• Those with brain metastases ( Brain metastases confirmed by imaging, inactive, asymptomatic, whether or not treated, and stable for more than 6 months can be included);
• Subjects have received MASCT or other cellular immunotherapy in the past 1 year.
• Subjects with severe coagulation dysfunction (PT, TT, APTT or fibrinogen was found to be abnormal and have clinical significance).
• Subjects have undergone significant bleeding symptoms or bleeding tendency within 3 months before enrollment, or have undergone arterial/venous thrombotic events within 6 months before enrollment. Subjects with long-term anticoagulation of warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300mg/ day or clopidogrel ≥75mg/ day) are not included in this study.
• Allogeneic organ transplanters, including bone marrow transplantation and peripheral stem-cell transplantation, corneal transplantation is not included.
• Subjects were using immunosuppressive agents or systemic or absorbable local hormones to achieve immunosuppressive purposes (dose \> 10mg/day of prednisone or other therapeutic hormones) and were still using them within 2 weeks before enrollment.
• Systematic or long-term use of immunomodulators such as interferon, thymosin and immunosuppressive drugs such as adrenocorticosteroids in half a year; Systematic or long-term use of immunomodulators for more than three months and immunosuppressive drugs for more than one month;
• Subjects have any active autoimmune disease or history of autoimmune disease.
• Subjects with active tuberculosis.
• Subjects who have undergone major surgery within 28 days before 1st treatment (according to the investigator's definition);
• Subjects were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.

Sponsors & Collaborators

• HRYZ Biotech Co.: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

• Zhou Y, Li M, Zhang B, Yang C, Wang Y, Zheng S, Tang L, Zhou C, Qian G, Huang Y, Yu W, Li H, Wang Y, He A, Shen Z, Zhang J, Li X, Yang Q, Hu H, Yao Y. A pilot study of multi-antigen stimulated cell therapy-I plus camrelizumab and apatinib in patients with advanced bone and soft-tissue sarcomas. BMC Med. 2023 Nov 29;21(1):470. doi: 10.1186/s12916-023-03132-x.

  PMID: 38031088 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 30, 2019
• Study Start: November 22, 2019
• Primary Completion: August 7, 2024
• Study Completion: December 5, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)