Solid TumorsPhase 1NCT05877651

MASCT-I in Patients With Metastatic or Recurrent Solid Tumors Who Failed Standard Therapy.

A Phase 1 study testing MASCT-I injection in people with Solid Tumors, run by HRYZ Biotech Co. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the safety and tolerability of MASCT-I in patients with metastatic or recurrent solid tumors who failed standard therapy. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Solid Tumors
What is being tested?: MASCT-I injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteChina
Study dates: 21 Apr 2020to 15 Oct 2021
Phase: 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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age ≥18 years and ≤70 years.
2. Written informed consent was obtained.
3. Pathologically confirmed solid tumors (including but not limited to soft tissue sarcoma/osteosarcoma, urothelial carcinoma, colorectal cancer), metastatic or recurrent, and failed or intolerant to standard therapy, or lack of effective treatment; Urothelial carcinoma including renal pelvic carcinoma, bladder cancer, ureteral carcinoma or urethral carcinoma.
4. ECOG performance status of 0-1.
5. Estimated life expectancy ≥ 6 months.
6. Patients must have at least one measurable lesion defined by RECIST 1.1.

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7. At least 4 weeks after the end of the last anti-tumor treatment before the 1st apheresis;
8. Patients with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis) :
Leukocytes ≥ 3.0 x 10^9/L;
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
Platelets ≥ 100 x 10^9/L;
Hemoglobin ≥ 90g/L;
Serum albumin ≥ 3.0g/dL;
Total bilirubin≤1.5×ULN; ALT/AST≤1.5×ULN (patients with liver metastasis or liver cancer, ≤5×ULN);
Creatinine clearance ≥50mL/min (Cockcroft -Gault formula);
Serum urea nitrogen/urea and creatinine ≤1.5×ULN (patients with urothelium carcinoma, ≤2.5×ULN);
9. 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 3 months after the end of the study treatment period; The serum or urine HCG test must be negative within 7 days before the study was included; And must be non lactating.

Who cannot join

1. Organ transplanters;
2. Allergic to sodium citrate or human albumin;
3. Patients who have undergone major surgery within 30 days before 1st apheresis (according to the investigator's definition);
4. Patients with uncontrolled 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. Patients have received radiotherapy, hormonotherapy, surgery or targeted therapy, or immunotherapy, and less than 4 weeks before the 1st apheresis;
6. Patients have active infection or fever of unknown cause during screening and before 1st apheresis is more than 38.5 degrees (patients with fever caused by cancer is eligible for enrollment according to investigator's judgement);

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7. Patients have clinically symptomatic central nervous system metastases (e.g., brain edema, need for hormonal intervention, or progression of brain metastases). Patients have previously received treatment for brain or leptomeningeal metastases were eligible if they have been clinically stable for at least 2 months and stopped systemic hormone therapy (dose >10mg/day prednisone or other therapeutic hormones) for more than 2 weeks;
8. Patients were using immunosuppressive agents or systemic or absorbable local hormones to achieve immunosuppressive purposes (dose > 10mg/day prednisone or other therapeutic hormones) and were still using them within 2 weeks before enrollment.
9. 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;
10. Patients have received MASCT or other cellular immunotherapy in the past 1 year;
11. Patients have any active autoimmune disease or history of autoimmune disease;
12. Patients 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;
13. Patients with active tuberculosis;
14. Known active hepatitis B virus (except for liver cancer) or hepatitis C virus infection, and/or HIV or syphilis infection;
15. Patients are receiving other systemic antineoplastic therapy or currently enrolled in other clinical study, or have participated in an investigational drug trial or used an investigational device within 4 weeks before 1st apheresis, or have not recovered from toxicity of the last treatment (adverse events should be grade 1 or less according to CTCAE criteria or return to the baseline before treatment);
16. According to investigator's judgement, those who are not suitable for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: A Single-center, Phase I Clinical Study to Evaluate the Safety and Tolerability of Multi-Antigen Stimulated Cell Therapy-I Injection (MASCT-I) in Patients With Metastatic or Recurrent Solid Tumors Who Failed Standard Therapy.

The purpose of this study is to evaluate the safety and tolerability of MASCT-I in patients with metastatic or recurrent solid tumors who failed standard therapy.

Read the detailed description

The study is divided into two stages. The first stage is divided into two groups, both of which adopted 3+3 design. The first group is given MASCT-I by administration method 1, and the second group is given by method 2. One of the administration method will be used in the second stage according to DLT and adverse events found in the first stage.

Conditions: Solid Tumors
Being tested: MASCT-I injection

What participants receive

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

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

Study groups in NCT05877651
Study group	Role	What they receive
MASCT-I injection	Experimental	MASCT-I injection Receives: Biological: MASCT-I injection

What is being measured

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

Adverse events and serious adverse events related to MASCT-I
Assessed by CTCAE V5.0
Measured: 8 weeks

Secondary outcomes (3)

Adverse events and serious adverse events related to MASCT-I
All adverse events and serious adverse events related to MASCT-I during the study
Measured: 2 years
Immune response to tumor-associated antigens
Measured by enzyme linked immunospot assay
Measured: 2 years
Concentration of Cytokines (IFNγ、IL2、IL4、IL6、IL10 and TNF)
Measured by flow cytometry or other methods
Measured: 2 years

Timeline

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

21 Apr 202015 Oct 2021

First posted26 May 2023
Study start21 Apr 2020
Primary completion15 Oct 2021
Study completion15 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05877651
Sponsor's protocol ID: MASCT-I-2001
Status last verified: May 2023
First submitted: 9 May 2023
Last updated: 30 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Phase I Clinical Study to Evaluate the Safety and Tolerability of Multi-Antigen Stimulated Cell Therapy-I Injection (MASCT-I) in Patients With Metastatic or Recurrent Solid Tumors Who Failed Standard Therapy.
ClinicalTrials.gov ID: NCT05877651
Acronym / sponsor ID: MASCT-I-2001
Conditions: Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: HRYZ Biotech Co.Industry (pharma, biotech, devices)
Study start: 21 Apr 2020 (actual)
Primary completion: 15 Oct 2021 (actual)
Study completion: 15 Oct 2021 (actual)
First posted: 26 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and tolerability of MASCT-I in patients with metastatic or recurrent solid tumors who failed standard therapy.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MASCT-I injection	Experimental	Biological: MASCT-I injectionMASCT-I injection

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

1. Age ≥18 years and ≤70 years.
2. Written informed consent was obtained.
3. Pathologically confirmed solid tumors (including but not limited to soft tissue sarcoma/osteosarcoma, urothelial carcinoma, colorectal cancer), metastatic or recurrent, and failed or intolerant to standard therapy, or lack of effective treatment; Urothelial carcinoma including renal pelvic carcinoma, bladder cancer, ureteral carcinoma or urethral carcinoma.
4. ECOG performance status of 0-1.
5. Estimated life expectancy ≥ 6 months.

Key exclusion criteria (16 listed)

1. Organ transplanters;
2. Allergic to sodium citrate or human albumin;
3. Patients who have undergone major surgery within 30 days before 1st apheresis (according to the investigator's definition);
4. Patients with uncontrolled 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. Patients have received radiotherapy, hormonotherapy, surgery or targeted therapy, or immunotherapy, and less than 4 weeks before the 1st apheresis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MASCT-I injectionThe final products of MASCT-I technology are dendritic cells (DC) and effector T cells	Biological	MASCT-I injection

Primary outcome

Adverse events and serious adverse events related to MASCT-I
Time frame: 8 weeks
Assessed by CTCAE V5.0

3 secondary outcomes

Adverse events and serious adverse events related to MASCT-I
Time frame: 2 years
Immune response to tumor-associated antigens
Time frame: 2 years
Concentration of Cytokines (IFNγ、IL2、IL4、IL6、IL10 and TNF)
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.

Related trials for Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ruihua Xu, Doctor principal investigator

Sun Yat-sen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MASCT-I injection in people with Solid Tumors, 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 17 inclusion and 16 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: finished, as of the sponsor's last update on 30 May 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events and serious adverse events related to MASCT-I (time frame: 8 weeks). 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 NCT05877651.

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 30 May 2023.