MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma

NCT06277154 | Recruiting Phase 2

• 1 other identifier: MASCT-I-2004
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.

Conditions

Leiomyosarcoma; Liposarcoma; Synovial Sarcoma; Angiosarcoma; Undifferentiated Pleomorphic Sarcoma; Epithelioid Sarcoma; Malignant Peripheral Nerve Sheath Tumors; Fibrosarcoma; Pleomorphic Rhabdomyosarcoma; Endometrial Stromal Sarcoma; Desmoplastic Small Round Cell Tumor

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  The time from the date of randomization to the first occurrence of radiological progression or death, whichever comes first.

  3 years

Secondary Outcomes (7)

• Overall Survival (OS)

  3 years

• Objective Response Rate (ORR)

  3 years

• Disease Control Rate (DCR)

  3 years

• Duration of response (DoR)

  3 years

• Adverse events and serious adverse events

  3 years

Other Outcomes (1)

• Immune response to tumor-associated antigens

  3 years

Study Arms (2)

MASCT-I+ Doxorubicin+ Ifosfamide

EXPERIMENTAL

The final products of MASCT-I technology are dendritic cells (DC) and effector T cells. DC cells injection will be given via subcutaneous injection, and T cells injection will be given via Intravenous (IV) infusion. Doxorubicin and Ifosfamide will be given per protocol.

Biological: MASCT-I; Drug: Doxorubicin; Drug: Ifosfamide

Doxorubicin+ Ifosfamide

ACTIVE COMPARATOR

Doxorubicin and Ifosfamide will be given per protocol.

Drug: Doxorubicin; Drug: Ifosfamide

Interventions

MASCT-I BIOLOGICAL

The final products of MASCT-I technology are dendritic cells (DC) and effector T cells.

MASCT-I+ Doxorubicin+ Ifosfamide

Doxorubicin DRUG

Commercially approved for cancer treatment

Also known as: Doxorubicin hydrochloride for Injection

Doxorubicin+ Ifosfamide; MASCT-I+ Doxorubicin+ Ifosfamide

Ifosfamide DRUG

Commercially approved for cancer treatment

Also known as: Ifosfamide for Injection

Doxorubicin+ Ifosfamide; MASCT-I+ Doxorubicin+ Ifosfamide

Eligibility Criteria

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

You may qualify if:

• Age≥18 years and≤70 years;
• According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor.
• No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.
• At least one measurable and assessable lesion defined by RECIST 1.1;
• ECOG performance status of 0-1;
• Estimated life expectancy≥6 months;
• Pulmonary function is basically normal;
• Subjects with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis): a) Hemoglobin ≥90g/L; b) Leukocyte≥3.5x10\^9/L; c) The absolute neutrophil count (ANC)\>1.5x10\^9/L; d) Platelet≥100x10\^9/L; e) ALT, AST≤2.5 ULN (Upper Limit of Normal), ALT, AST≤5 ULN for liver metastases; f) ALP≤2.5 ULN; g) Serum total bilirubin≤1.5 ULN; Patients with Gilbert's syndromes (persistent or repeated hyperbilirubinemia \[mainly unconjugated bilirubin\], in the absence of evidence of hemolysis or liver disease), are allowed to enroll with investigator's agreement; h) Serum urea nitrogen or urea and creatinine≤2.5 ULN; i) Serum albumin≥35g/L; j) PT, APTT, INR≤1.5 ULN (without anticoagulation treatment);
• Obtain the written informed consent of the patient/legal representative;
• Subjects with potential fertility must agree to use effective contraceptive measure during and within 6 months after the treatment period. HCG test for female with potential fertility must be negative before the study was included.

You may not qualify if:

• Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be included.) or other antineoplastic drugs such as anlotinib, gemcitabine, within 4 weeks before randomization, or have received Chinese medicine or proprietary Chinese medicine for anti-tumor treatment within 2 weeks before randomization.
• Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary fibroma/hemangiopericytoma, acinous soft tissue sarcoma, extraosseous myxoid chondrosarcoma, gastrointestinal stromal tumor, invasive fibroma, renal angiomyolipoma, malignant mesothelioma, clear cell sarcoma, Ewing's sarcoma, etc., which are not suitable for Doxorubicin+ Ifosfamide (AI) treatment.
• Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg/m2 doxorubicin.
• Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.
• Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg/day prednisone or its equivalent) and were still using them within 2 weeks before randomization.
• Use of immunomodulators and were still using them within 2 weeks before randomization.
• Allergic to sodium citrate or human albumin.
• Subjects with uncontrolled pleural effusion and abdominal effusion requiring repeated drainage and with moderate or higher volume of pericardial effusion.
• Have known active central nervous system (CNS) or meningeal metastases. Subjects with previously treated brain metastases may participate provided they are stable based on the following: 1) any neurologic symptoms have returned to baseline at least 2 weeks before randomization, 2) no requirement for steroids at least 2 weeks before randomization or receiving low-dose of steroids (Not exceeding 10mg/day prednisone or its equivalent).
• Have any active autoimmune disease or history of autoimmune disease.
• Subjects with active tuberculosis.
• Subjects were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.
• Severe cardiovascular disease, such as: (1) complete left bundle branch block or III atrioventricular block; (2) history of myocardial infarction, angioplasty, coronary artery bypass graft; (3) prolonged QT/QTc interval at baseline (male\>450ms, female \>480ms); (4) LVEF≤50%; (5) heart failure of NYHA class 2 or higher; (6) poorly controlled hypertension (BP≥150/95 mmHg, despite optimal medical treatment); (7) cardiomyopathy or severe arrhythmia and may have impact on the study based on investigator's judgement.
• Subjects with history of thrombus or experienced a cerebrovascular accident within 6 months before randomization;
• Other malignant tumors (except cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) in the past 5 years;

Sponsors & Collaborators

• HRYZ Biotech Co.: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Leiomyosarcoma; Liposarcoma; Sarcoma, Synovial; Hemangiosarcoma; Histiocytoma, Malignant Fibrous; Sarcoma; Neurofibrosarcoma; Fibrosarcoma; Sarcoma, Endometrial Stromal; Desmoplastic Small Round Cell Tumor

Interventions

Doxorubicin; Injections; Ifosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Adipose Tissue; Neoplasms, Connective Tissue; Neoplasms, Vascular Tissue; Histiocytoma; Neoplasms, Fibrous Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neoplasms, Complex and Mixed; Endometrial Stromal Tumors; Endometrial Neoplasms; Uterine Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Drug Administration Routes; Drug Therapy; Therapeutics; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xing Zhang

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Zhang Xing

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Huang

CONTACT

021-37690016; huangwenjin@shhryz.com

Xuemin Rao

CONTACT

raoxuemin@shhryz.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 26, 2024
• Study Start: February 21, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)