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MASCT-I Combined With PD1 and Apatinib in the Treatment of Tissue Sarcoma

Sponsor
SYZ Cell Therapy Co.. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04074564
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
24.7
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the MASCT-I in combination PD1 Antibody and Apatinib are effective in the treatment of Advanced Osteosarcoma and Soft Tissue Sarcoma

Condition or Disease Intervention/Treatment Phase
  • Combination Product: MASCT-I,PD1 Antibody,Apatinib
 Early Phase 1

Detailed Description

This is a single-center,Exploratory Research for evaluating the efficacy of MASCT-I With PD1 Antibody and Apatinib in patients with advanced Advanced Osteosarcoma and Soft Tissue Sarcoma and preliminarily assessing the preliminary observation of immune response and safety. About 20 cases of adult patients are to be recruited.

The patients were randomly divided into two groups. One group received MASCT-I A+PD1 antibody+Apatinib treatment, the other group received MASCT-I B+PD1 antibody+Apatinib treatment. In combination with MASCT-I, the dosage and cycle of PD1 antibody and Apatinib did not change.

MASCT-I A and MASCT-I B are mainly administered with different frequencies of MASCT-I.

After treatment, patients were assessed by CT imaging every 8 weeks. If the disease progressed or could not be tolerated, or when the end of treatment (104 weeks), the treatment would be discontinued, whichever happened first.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
To Explore the Efficacy of MASCT-I Combined With PD1 Antibody and Apatinib Mesylate in the Treatment of Advanced Osteosarcoma and Soft Tissue Sarcoma
Anticipated Study Start Date :
Oct 16, 2019
Anticipated Primary Completion Date :
Oct 7, 2021
Anticipated Study Completion Date :
Nov 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: A group

MASCT-I A+PD1 antibody+Apatinib combination therapy

Combination Product: MASCT-I,PD1 Antibody,Apatinib
Multi-antigen autoimmune cell injection (MASCT-I) is an adoptive cellular immunotherapeutic product being developed by Heng Ruiyuan. PD1 antibody is a blocking antibody of human programmed death receptor-1 (PD-1). It can bind to PD-1 receptor, block its interaction with PD-L 1 and PD-L2, release PD-1 pathway mediated inhibition of immune response, including anti-tumor immune response. Apatinib is a small molecule targeted anti-angiogenesis drug. It can highly selectively compete for ATP binding sites of endothelial growth factor R-2, block downstream signal transduction and inhibit neovascularization in tumor tissues.
Experimental: B group

MASCT-I B+PD1 antibody+Apatinib combination therapy

Combination Product: MASCT-I,PD1 Antibody,Apatinib
Multi-antigen autoimmune cell injection (MASCT-I) is an adoptive cellular immunotherapeutic product being developed by Heng Ruiyuan. PD1 antibody is a blocking antibody of human programmed death receptor-1 (PD-1). It can bind to PD-1 receptor, block its interaction with PD-L 1 and PD-L2, release PD-1 pathway mediated inhibition of immune response, including anti-tumor immune response. Apatinib is a small molecule targeted anti-angiogenesis drug. It can highly selectively compete for ATP binding sites of endothelial growth factor R-2, block downstream signal transduction and inhibit neovascularization in tumor tissues.

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate（ORR） [up to 104 weeks]

    Percentage of patients with PR and CR in the total number of patients

Secondary Outcome Measures

  1. Progression-Free Survival (PFS) [up to 96 weeks]

    The length of time from enrollment until the time of progression of disease

  2. Disease Control Rate (DCR) [up to 96 weeks]

    Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) based on RESIST v1.1 criteria

  3. Overall Survival (OS) [up to 96 weeks]

    From the time the patient signed the informed consent to the time of death

  4. Incidence of Treatment Adverse Events（Safety） [up to 104 weeks]

    all the Treatment adverse events and serious adverse events obtained during the study of all the patients included in the whole study

  5. immune response [up to 104 weeks]

    Specific immune responses to tumor-associated antigens were detected at different time points according to different administration modes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. The age of screening was 14-70 years old.

  2. Obtain the written informed consent of the patient/legal representative;

  3. In patients with unresectable recurrence or metastasis of advanced bone and soft tissue sarcoma, histological or cytological evidence shows that objective imaging progress (RECIST 1.1) occurs after first-line or multi-line treatment, and the maximum diameter of metastatic lesions is ≤ 8 cm.

  4. At least one measurable and assessable lesion (based on RECIST 1.1 assessment);

  5. ECOG is 0-1 (amputees, score can be 2)

  6. Life expectancy (≥ 6 months);

  7. At least 4 weeks after the end of the last chemotherapy;

  8. Cardiopulmonary function is basically normal.

  9. Tumor tissue specimens (for PDL1, MSI detection) can be provided.

  10. Blood samples can be provided (for the detection of immune response).

  11. The function of important organs meets the following requirements (no blood components and growth factors are allowed to be used within 14 days before screening).

  1. Hemoglobin ≥ 90g/L

  2. Leukocyte ≥3.0 *109/L

  3. The absolute neutrophil count (ANC) ≥ 1.5 x 109/L.

  4. Platelet ≥ 70 *109/L

  5. ALT, AST ≤ 2.5 times normal upper limit value;

  6. ALP ≤ 2.5 times normal upper limit

  7. Serum total bilirubin < 1.5 times the normal upper limit; this does not apply to the diagnosis of Gilbert's

Patients with syndromes (persistent or repeated hyperbilirubinemia [mainly unconjugated bilirubin], in the absence of evidence of hemolysis or liver disease), are allowed to consult a doctor.

  1. Serum urea nitrogen and creatinine ≤ 1.5 times normal upper limit

  2. Serum albumin ≥30g/L

Exclusion Criteria:

  1. Those with bone or brain metastases;

  2. Subjects were using immunosuppressive agents or systemic or absorbable local hormones to achieve immunosuppressive purposes (dose > 10mg/prednisone or other therapeutic hormones) and were still using them within 2 weeks before admission.

  3. 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;

  4. The subjects had received radiotherapy in the past one year.

  5. The subjects had received MASCT or other cellular immunotherapy or PD1/PDL1/CTLA-4 antibody therapy in the past 1 year.

  6. Subjects had any active autoimmune disease or history of autoimmune disease.

  7. The subjects had active tuberculosis.

  8. Subjects were infected with hepatitis B, hepatitis C or HIV, or syphilis.

  9. Pregnancy or planned pregnancy;

  10. People allergic to sodium citrate or human albumin;

  11. Severe coagulation dysfunction (PT, TT, APTT or any of fibrinogen abnormalities and clinical significance);

  12. According to the judgement of the researcher, it is not suitable

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Sixth People's Hospital Shanghai Shanghai China

Sponsors and Collaborators

  • SYZ Cell Therapy Co..

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SYZ Cell Therapy Co..
ClinicalTrials.gov Identifier:
NCT04074564
Other Study ID Numbers:
  • SYZCellTherapy
First Posted:
Aug 30, 2019
Last Update Posted:
Sep 19, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by SYZ Cell Therapy Co..
MASCT-I
the Efficacy
Combined therapy
Additional relevant MeSH terms:
Sarcoma
Apatinib
Antibodies

Study Results

No Results Posted as of Sep 19, 2019