CancerEarly Phase 1Reboot-101NCT05707325
Safety, Tolerability and Preliminary Efficacy of Engineered Red Blood Cell in Patients With Advanced Malignancies
A Early Phase 1 study testing engineered red blood cell in people with Cancer and Solid Tumor, run by Westlake Therapeutics at 1 site in China.
Trial summary
This is an investigator-initiated trial aimed at evaluating the safety and preliminary efficacy of a novel red blood cell-based therapy, where engineered red blood cells are conjugated with checkpoint inhibitors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer, Solid Tumor, Hematologic Malignancy
- What is being tested?
- engineered red blood cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2023to 31 Jul 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Histologically- or cytologically-proven advanced malignancies;
- 2.Male or female, 18 years of age or older but no more than 75 at the time of signing informed consent;
- 3.Dose escalation stage: (1) patients with advanced solid tumors who have received at least 2 regimens, and PDx monotherapy or combination therapy is included in the last regimen ; or patients received 1st regimen or above who cannot tolerate standard therapy but PDx monotherapy or combination therapy should be included in the last regimen.(2)Patients with relapsed and refractory malignant lymphomas (including: classic Hodgkin lymphoma (cHL), primary mediastinal large B-cell lymphoma PMBCL , Extranodal NK/T-cell lymphoma ENKTCL, mycosis fungoides/Sezari syndrome MF/SS) , or patients have no standard therapy, or are unable to receive standard therapy, PDx monotherapy or combination therapy is used in the last regimen.(3)All patients did not receive systemic therapy after disease progression and the time of disease progression cannot exceed 3 months, radiotherapy was acceptable (definition of secondary resistance: achieved disease control (including CR/PR/ SD), but then disease progression after PDx therapy);
- 4.Dose expansion stage:(1)patients with advanced solid tumors who have received at least 1 regimen or these is no standard systematic therapy or patients can not recieve standard therapy, but PDx monotherapy or combination therapy should be included in the last regimen.(2)patients with relapsed and refractory malignant lymphomas who have no standard therapy or can not receive standard therapy, but PDx monotherapy or combination therapy should be included in the last regimen.(3)All patients did not receive systemic therapy after disease progression and the time of disease progression cannot exceed 3 months, radiotherapy was acceptable (definition of secondary resistance: achieved disease control (including CR/PR/ SD), but then disease progression after PDx therapy);
- 5.Solid tumor：at least one lesion that is measurable according to RECIST 1.1;lymphomas:at least one visble or evaluable lesion that is measurable according to Lugano2014;
- 6.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
Show all 11Show fewer
- 7.Take the shorter one as the washout period before experimental treatment (28 days after the last tumor treatment, or 5 half lives);
- 8.Resolution of all acute reversible toxic effects of prior therapy or surgical procedure to baseline or Grade ≤1 (except alopecia and peripheral neurotoxicity);
- 9.Adequate organ function;
- 10.Estimated life expectancy of ≥12 weeks;
- 11.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
Who cannot join
- 1.Any active or recently diagnosed clear or suspected autoimmune disorder disease;
- 2. Other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, liver cirrhosis, active bleeding, etc., and those with uncontrolled or serious cardiovascular disease, such as the NYHA II or higher heart failure, unstable angina, myocardial infarction and other cardiovascular disease within 6 months before first administration, and uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
- 3.Has known active Hepatitis B or Hepatitis C or HIV;
- 4.Active brain metastases and/or cancerous meningitis;
- 5.Known history of any diseases affecting the quality and stability of erythropoiesis;
- 6.The spleen has been removed or, as judged by the investigator, a splenectomy may be planned during the trial;
- 7.Received at least one alive virus vaccination within 6 months before the first dose (except for the COVID-19 inactivated vaccine);
- 8.Known history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People'S Hospital
Hangzhou, Zhejiang, 310014
Tong Xiangmin, Ph.D, 13750816623, tongxiangmin@163.com
About this study
Official title: A Multicenter, Single-arm, Open-label, Dose-escalation and Dose-expansion Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of Engineered Red Blood Cell in Patients With Advanced Malignancies
This is an investigator-initiated trial aimed at evaluating the safety and preliminary efficacy of a novel red blood cell-based therapy, where engineered red blood cells are conjugated with checkpoint inhibitors.
Read the detailed description
The present study has 2 parts，including dose escalation and dose expansion。The dose escalation part is carried out according to the "3+3" increasing principle. At least four dose groups are predefined based on the number of engineered red blood cells, specifically 1e11, 2e11, 3e11, 3.5e11,etc.
Dose expansion part will be decided according to dose escalation part.
- Conditions
- Cancer, Solid Tumor, Hematologic Malignancy
- Being tested
- engineered red blood cell
- Keywords
- solid tumors, hematologic malignancies
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
engineered red blood cellDrug
engineered red blood cell
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation in Solid tumors and Hematologic malignancies | Experimental | In Dose Escalation part， all patients will be enrolled in different doses according to the Study Protocol for evaluate the recommend dose Receives: Drug: engineered red blood cell |
| Dose Expansion in Solid tumors and Hematologic malignancies | Experimental | In Expansion part， all patients will be enrolled in recommended dose Receives: Drug: engineered red blood cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) in Participants in escalating part.
DLTs were assessed according to NCI-CTCAE v.5.0 during the first cycle (21 days) and were defined as occurrence of any of the following toxicities if judged by the investigator to be possibly, probably or definitely related to study drug administration。
Measured: 21 days
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who experienced an AE was reported for all patients.
Measured: Up to approximately 24 months
Secondary outcomes (4)
Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1(only for solid tumor) or Lugano2014( only for lymphomas)
Measured: per 6 weeks
Anti-drug antibody (ADA)
Describe the number and percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA.
Measured: 1 year
Maximum Concentration (Cmax) of engineered red blood cells in all Participants
Blood samples were collected at specified intervals for the determination of Cmax. Cmax was defined as the maximum concentration of engineered red blood cells reached. Cmax was based on noncompartmental analysis and reported for all participants
Measured: Cycle 1: Pre-dose, post-dose at 0.5, 6 and 12 hours and Days 2, 3, 8 and 15
Time to Maximum Concentration (Tmax) f engineered red blood cells in all Participants
Blood samples were collected at specified intervals for the determination of Tmax. Tmax was defined as time to the maximum concentration of engineered red blood cells reached. Tmax was based on noncompartmental analysis and reported for all participants
Measured: Cycle 1: Pre-dose, post-dose at 0.5, 6 and 12 hours and Days 2, 3, 8 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start16 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The dose escalation part is carried out according to the "3+3" increasing principle. At least four dose groups are predefined based on the number of engineered red blood cells, specifically 1e11, 2e11, 3e11, 3.5e11,etc. Dose expansion part will be decided according to dose escalation part.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westlake Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- xiangmin Tong, Phd, Principal investigator, ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707325
- Sponsor's protocol ID
- Reboot-101
- Acronym
- Reboot-101
- Status last verified
- Jul 2024
- First submitted
- 11 Jan 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Open-label, Dose-escalation and Dose-expansion Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of Engineered Red Blood Cell in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05707325
- Acronym / sponsor ID
- Reboot-101 / Reboot-101
- Conditions
- Cancer, Solid Tumor, Hematologic Malignancy
- Keywords
- solid tumors, hematologic malignancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Westlake TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 31 Jan 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.
This is an investigator-initiated trial aimed at evaluating the safety and preliminary efficacy of a novel red blood cell-based therapy, where engineered red blood cells are conjugated with checkpoint inhibitors.
Detailed description
The present study has 2 parts，including dose escalation and dose expansion。The dose escalation part is carried out according to the "3+3" increasing principle. At least four dose groups are predefined based on the number of engineered red blood cells, specifically 1e11, 2e11, 3e11, 3.5e11,etc.
Dose expansion part will be decided according to dose escalation part.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The dose escalation part is carried out according to the "3+3" increasing principle. At least four dose groups are predefined based on the number of engineered red blood cells, specifically 1e11, 2e11, 3e11, 3.5e11,etc. Dose expansion part will be decided according to dose escalation part.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation in Solid tumors and Hematologic malignancies | Experimental | Drug: engineered red blood cellIn Dose Escalation part， all patients will be enrolled in different doses according to the Study Protocol for evaluate the recommend dose |
| Dose Expansion in Solid tumors and Hematologic malignancies | Experimental | Drug: engineered red blood cellIn Expansion part， all patients will be enrolled in recommended dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1.Histologically- or cytologically-proven advanced malignancies;
- 2.Male or female, 18 years of age or older but no more than 75 at the time of signing informed consent;
- 3.Dose escalation stage: (1) patients with advanced solid tumors who have received at least 2 regimens, and PDx monotherapy or combination therapy is included in the last regimen ; or patients received 1st regimen or above who cannot tolerate standard therapy but PDx monotherapy or combination therapy should be included in the last regimen.(2)Patients with relapsed and refractory malignant lymphomas (including: classic Hodgkin lymphoma (cHL), primary mediastinal large B-cell lymphoma PMBCL , Extranodal NK/T-cell lymphoma ENKTCL, mycosis fungoides/Sezari syndrome MF/SS) , or patients have no standard therapy, or are unable to receive standard therapy, PDx monotherapy or combination therapy is used in the last regimen.(3)All patients did not receive systemic therapy after disease progression and the time of disease progression cannot exceed 3 months, radiotherapy was acceptable (definition of secondary resistance: achieved disease control (including CR/PR/ SD), but then disease progression after PDx therapy);
- 4.Dose expansion stage:(1)patients with advanced solid tumors who have received at least 1 regimen or these is no standard systematic therapy or patients can not recieve standard therapy, but PDx monotherapy or combination therapy should be included in the last regimen.(2)patients with relapsed and refractory malignant lymphomas who have no standard therapy or can not receive standard therapy, but PDx monotherapy or combination therapy should be included in the last regimen.(3)All patients did not receive systemic therapy after disease progression and the time of disease progression cannot exceed 3 months, radiotherapy was acceptable (definition of secondary resistance: achieved disease control (including CR/PR/ SD), but then disease progression after PDx therapy);
- 5.Solid tumor：at least one lesion that is measurable according to RECIST 1.1;lymphomas:at least one visble or evaluable lesion that is measurable according to Lugano2014;
Key exclusion criteria (8 listed)
- 1.Any active or recently diagnosed clear or suspected autoimmune disorder disease;
- 2. Other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, liver cirrhosis, active bleeding, etc., and those with uncontrolled or serious cardiovascular disease, such as the NYHA II or higher heart failure, unstable angina, myocardial infarction and other cardiovascular disease within 6 months before first administration, and uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
- 3.Has known active Hepatitis B or Hepatitis C or HIV;
- 4.Active brain metastases and/or cancerous meningitis;
- 5.Known history of any diseases affecting the quality and stability of erythropoiesis;
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 |
|---|---|---|
| engineered red blood cellengineered red blood cell | Drug | Dose Escalation in Solid tumors and Hematologic malignancies, Dose Expansion in Solid tumors and Hematologic malignancies |
Primary outcome
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) in Participants in escalating part.
Time frame: 21 days
DLTs were assessed according to NCI-CTCAE v.5.0 during the first cycle (21 days) and were defined as occurrence of any of the following toxicities if judged by the investigator to be possibly, probably or definitely related to study drug administration。
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to approximately 24 months
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who experienced an AE was reported for all patients.
4 secondary outcomes
Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: per 6 weeks
Anti-drug antibody (ADA)
Time frame: 1 year
Maximum Concentration (Cmax) of engineered red blood cells in all Participants
Time frame: Cycle 1: Pre-dose, post-dose at 0.5, 6 and 12 hours and Days 2, 3, 8 and 15
Time to Maximum Concentration (Tmax) f engineered red blood cells in all Participants
Time frame: Cycle 1: Pre-dose, post-dose at 0.5, 6 and 12 hours and Days 2, 3, 8 and 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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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.
xiangmin Tong, Phd principal investigator
ZHEJIANG PROVINCIAL PEOPLE'S HOSPITAL of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing engineered red blood cell in people with Cancer and Solid Tumor, run by Westlake Therapeutics 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 11 inclusion and 8 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 24 Jul 2024. 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?
Contact xiangmin Tong, Phd (+86-13750816623, tongxiangmin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) in Participants in escalating part. (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2024.