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SarcomaEarly Phase 1NCT04074564

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

A Early Phase 1 study testing MASCT-I, Camrelizumab,Apatinib in people with Sarcoma, run by HRYZ Biotech Co. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 70 years
Conditions the study is for
Sarcoma
What is being tested?
MASCT-I, Camrelizumab,Apatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
22 Nov 2019to 5 Dec 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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);
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  • 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):
  • Hemoglobin ≥ 90g/L;
  • Leukocyte ≥3.0 *109/L;
  • The absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
  • Platelet ≥ 70 *109/L;
  • ALT, AST ≤ 2.5 ULN (Upper Limit of Normal);
  • ALP ≤ 2.5 ULN;
  • 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 consult a doctor.
  • Serum urea nitrogen and creatinine ≤ 1.5 ULN;
  • Serum albumin ≥30g/L.

Who cannot join

  • 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.
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  • 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.
  • Subjects with or have history of peripheral nervous system disorders or mental disorders.
  • Subjects have active infection or fever of unknown cause during screening and before 1st treatment more than 38.5 degrees (patients with fever caused by cancer is eligible for enrollment according to investigator's judgement);
  • Chronic systemic diseases such as severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease, or diabetes mellitus (fasting plasma glucose > 7.0mmol/L or 2-hour postprandial plasma glucose >11.1mmol/L) that cannot be well controlled by medical treatment, hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90mmHg);
  • Subjects with other malignant tumors (except cured skin basal cell carcinoma, thyroid carcinoma and cervical carcinoma in situ) within 5 years before enrollment or at enrollment;
  • Subjects with poorly controlled cardiac symptoms or diseases, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) LVEF<50% (6) poorly controlled arrhythmias (QTcF interval > 450ms for men and > 470ms for women);
  • According to investigator's judgement, those who are not suitable for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality

    Xuemin Rao, 13151526280, raoxuemin@shhryz.com

    Yang Yao, doctor

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Study Evaluating the Safety and Efficacy of MASCT-I Combined With Apatinib Mesylate and/or Camrelizumab in the Treatment of Patients With Advanced Bone and Soft Tissue Sarcoma

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.

Read the detailed description

This is a single-center, open-label, exploratory study to evaluate the safety, preliminary efficacy and immune response of MASCT-I with Apatinib and/or Camrelizumab in the treatment of patients with advanced bone and soft-tissue sarcoma. 60 patients with advanced bone and soft-tissue sarcoma will be recruited.

This study include two parts. In part A, patients were randomized into two groups: one group received MASCT-I A+Camrelizumab+Apatinib, and the other group received MASCT-I B +Camrelizumab+Apatinib, the administration schedules for MASCT-I is different between two groups. A total of 20 patients were planned to be recruited in part A. In part B, patients will be treated with MASCT-I (based on the administration schedule selected from part A) in combination with Apatinib. 40 patients were planned to be recruited in part B.

MASCT-I A and MASCT-I B were administered mainly at different frequencies.

Conditions
Sarcoma
Being tested
MASCT-I, Camrelizumab,Apatinib
Keywords
MASCT-I, Cell-based immunotherapy, Camrelizumab, Apatinib, Tumor associated antigen
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MASCT-I, Camrelizumab,ApatinibCombination 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 groups in NCT04074564
Study groupRoleWhat they receive
Part AExperimentalSubgroup 1: MASCT-I A+Camrelizumab+Apatinib combination therapy; Subgroup 2: MASCT-I B+Camrelizumab+Apatinib combination therapy
Receives: Combination Product: MASCT-I, Camrelizumab,Apatinib
Part BExperimentalMASCT-I (based on the administration schedule selected from part A) in combination with Apatinib
Receives: Combination Product: MASCT-I, Camrelizumab,Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events and serious adverse events (safety)

    All adverse events and serious adverse events during the study

    Measured: 4 years

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    The percentage of participants with complete response (CR) or partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population.

    Measured: 4 years

  2. Progression-Free Survival (PFS)

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

    Measured: 4 years

  3. Disease Control Rate (DCR)

    The percentage of participants with CR, PR, or stable disease (SD) relative to the total number of participants within the analysis population as determined by Investigators per RECIST v1.1.

    Measured: 4 years

  4. Overall Survival (OS)

    The interval of time between the date of enrollment and the date of death.

    Measured: 4 years

  5. immune response

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

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2019
  2. Study start22 Nov 2019
  3. Primary completion7 Aug 2024 (estimated)
  4. Study completion5 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04074564
Sponsor's protocol ID
MASCT-I-1005
Status last verified
Oct 2023
First submitted
26 Aug 2019
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38031088

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing MASCT-I, Camrelizumab,Apatinib in people with Sarcoma, run by HRYZ Biotech Co. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events and serious adverse events (safety) (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04074564, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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