Multiple MyelomaEarly Phase 1NCT06067581
the Safety and Efficacy of SENL103 Autologous T Cell Injection
A Early Phase 1 study testing SENL103 in people with Multiple Myeloma, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
To observe the safety and efficacy of SENL103 cells in the treatment of patients with recurrent or refractory plasma cell blood tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- SENL103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2023to Aug 2025
- 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
- age 18-75 years old, gender is not limited;
- Understand and know about this study and sign the informed consent voluntarily;
- Patients diagnosed with recurrent/refractory plasma cell blood tumors must: a) have received at least 3 kinds of anti-plasma cell blood tumor therapy, including at least one proteasome inhibitor and one immunomodulator; b) documented progression within 12 months of treatment of the most recent antiplasmacytic blood tumor, or efficacy assessed as SD or PD within 60 days of treatment of the most recent antiplasmacytic blood tumor;
- meet one of the following detection indicators: a) serum M protein ≥5g/L; b) Urine M protein ≥200mg/24h; c) Affected serum free light chain ≥100mg/L and abnormal serum free light chain ratio; d) Bone marrow plasma cell ratio ≥10%;
- ECOG score is 0-2 points; 6, liver and kidney function, cardiopulmonary function meet the following requirements: a) blood creatinine ≤150umol/L, or creatinine clearance (estimated by Cockcroft Gaultra formula) ≥40ml/min (if the kidney function injury caused by rapid progression of the primary disease, the inclusion criteria can be appropriately relaxed, and the decision is made by the investigator); b) Total bilirubin ≤2×ULN; ALT≤3 x ULN, AST≤3 x ULN; c) Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no serious arrhythmias; d) The subjects had no active pulmonary infection, and the blood oxygen saturation of indoor air was > 90%;
- 7. The subjects had no contraindications for peripheral blood monopexy, hemoglobin ≥60g/L, platelets ≥50×10^9/L, neutrophils ≥1×10^9/L; 8. Expected survival >12 weeks; 9. The urine pregnancy test of female subjects of childbearing age should be negative and not in the lactation period; Women or men of reproductive age were required to use effective contraception throughout the study.
Who cannot join
- Have had severe rapid hypersensitivity to any of the drugs to be used in this study;
- History of central nervous system (CNS) diseases, such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy; Known active central nervous system (CNS) involvement or history of modification or clinical signs of multiple myeloma meningeal/spinal meningeal involvement;
- Accompanied by other uncontrolled malignancies (except adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and thyroid cancer after radical surgery);
- The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any grade III (moderate) or grade IV (severe) heart disease (according to the New York Heart Society Functional Grading Method NYHA*); Patients with a history of myocardial infarction, angioplasty or stenting, unstable angina pectoris, or other clinically significant heart disease within 12 months prior to enrollment;
- Previous patients with craniocerebral trauma, cerebrovascular accident, more serious cerebral ischemia or cerebral hemorrhage diseases;
- The investigator determines that there are serious complications or diseases that increase the risk of the subject or affect the study, including but not limited to, for example, cirrhosis of the liver, recent major trauma, etc.;
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- Allogeneic hematopoietic stem cell transplantation performed within six months prior to screening, or hematopoietic stem cell transplantation performed during the screening period for any immunosuppressive treatment due to graft-versus-host disease;
- Patients with autoimmune diseases, immune deficiencies or other immunosuppressants (other than low-dose glucocorticoids) are required;
- Any uncontrolled active infection, including but not limited to active tuberculosis; Suspected uncontrollable fungal, bacterial, viral, or other infection prior to enrollment;
- Received attenuated live vaccine within 4 weeks before anapheresis;
- Subjects with active hepatitis (hepatitis B virus DNA >100IU/ml or hepatitis C virus RNA [HCVRNA] positive), syphilis, and other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons; People infected with CMV virus (CMV DNA test positive);
- The subject has a history of alcoholism, drug abuse or mental illness;
- Failure to follow the following treatment requirements needs to be excluded:
- Hormones: Subjects shall not receive more than 5mg of prednisone or other equivalent doses of corticosteroids and other immunosuppressive drugs within 72 hours prior to PBMC cell collection; B) Prior anti-tumor therapy (prior to PBMC monotherapy) : targeted therapy, epigenetic therapy or investigational drug therapy, or use of invasive investigational medical devices must have ended 14 days prior to PBMC cell collection or at least 5 half-lives (whichever is longer); Treatment of multiple myeloma with monoclonal antibodies ended at least 21 days before cell collection; Cytotoxic therapy should be completed at least 14 days before cell collection. Protease inhibitor treatment should end at least 14 days before cell collection. The immunomodulator should end at least 7 days before cell collection; C) Radiotherapy: must be completed no later than 4 weeks before PBMC cell collection, but if the radiotherapy field covered ≤ 5% of bone marrow reserve, participants were eligible to participate regardless of the radiotherapy end date; D) Anti-T cell antibody drugs (such as alenzumab) must be terminated 8 weeks before cell collection;
- Researchers consider it inappropriate to participate in this experiment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei
Chunrui Li, PhD&MD, 13647233185, cunrui5650@126.com
About this study
Official title: Clinical Study on the Safety and Efficacy of SENL103 Autologous T Cell Injection in the Treatment of Recurrent or Refractory Plasma Cell Blood Tumors
To observe the safety and efficacy of SENL103 cells in the treatment of patients with recurrent or refractory plasma cell blood tumors.
Read the detailed description
Primary endpoint To observe the number and incidence of adverse events after intravenous infusion of SENL103. To evaluate possible adverse reactions recorded within 1 month after SENL103 infusion, including the number, incidence and severity of symptoms such as cytokine release syndrome and neurotoxic reactions; Secondary endpoints
- Efficacy indicators: The efficacy after cell retransfusion was observed by strict complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), stable disease (SD), and progression-free survival (PFS rate);
- PK index: the highest concentration of SENL103 cells amplified in peripheral blood (Cmax, measured by flow cytometry and qPCR), the time to reach the highest concentration (Tmax) and the duration of cell survival in the patient;
- PD index: proportion of peripheral blood plasma cells, concentration of free BCMA and cytokine release at each time point;
- Quality of life assessment: the changes of subjects' quality of life before and after treatment were observed.
- Conditions
- Multiple Myeloma
- Being tested
- SENL103
- Keywords
- BCMA
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENL103Biological
Patients will be treated with BCMA CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| BCMA CART | Experimental | This study will follow the classic "3+3" design and increase the dose according to three dose groups. Each dose group will have 3-6 eligible subjects selected according to the inclusion/exclusion criteria, with a dose of 1.0 × 10^6, 2.0 × 10^6, 3.0 × Increase the dose by 10^6 CAR-T cells/kg. Receives: Biological: SENL103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe the number and incidence of adverse events after intravenous infusion of SENL103.
The number, incidence and severity of all recorded adverse reactions, including cytokine release syndrome and neurotoxicity.
Measured: within 1 months after SENL103 infusion.
Secondary outcomes (3)
Efficacy indicators
To observe the efficacy of cell reperfusion, strict complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), disease stabilization (SD), disease-free progression-free survival (PFS rate), survival (OS) were adopted.
Measured: within 3 months after SENL103 infusion.
PD index
the proportion of BCMA+ plasma cells in peripheral blood, the concentration of free BCMA and the release of cytokines at each time point;
Measured: within 3 months after SENL103 infusion.
PK index
the highest concentration of SENL103 cells amplified in peripheral blood (Cmax, measured by flow cytometry and qPCR), the time to reach the highest concentration (Tmax) and the duration of cell survival in the patient;
Measured: within 3 months after SENL103 infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start21 Aug 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chunrui Li, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067581
- Sponsor's protocol ID
- SENL103 CAR-T
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of SENL103 Autologous T Cell Injection in the Treatment of Recurrent or Refractory Plasma Cell Blood Tumors
- ClinicalTrials.gov ID
- NCT06067581
- Acronym / sponsor ID
- SENL103 CAR-T
- Conditions
- Multiple Myeloma
- Keywords
- BCMA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 5 Oct 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.
To observe the safety and efficacy of SENL103 cells in the treatment of patients with recurrent or refractory plasma cell blood tumors.
Detailed description
Primary endpoint To observe the number and incidence of adverse events after intravenous infusion of SENL103. To evaluate possible adverse reactions recorded within 1 month after SENL103 infusion, including the number, incidence and severity of symptoms such as cytokine release syndrome and neurotoxic reactions; Secondary endpoints
- Efficacy indicators: The efficacy after cell retransfusion was observed by strict complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), stable disease (SD), and progression-free survival (PFS rate);
- PK index: the highest concentration of SENL103 cells amplified in peripheral blood (Cmax, measured by flow cytometry and qPCR), the time to reach the highest concentration (Tmax) and the duration of cell survival in the patient;
- PD index: proportion of peripheral blood plasma cells, concentration of free BCMA and cytokine release at each time point;
- Quality of life assessment: the changes of subjects' quality of life before and after treatment were observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA CART | Experimental | Biological: SENL103This study will follow the classic "3+3" design and increase the dose according to three dose groups. Each dose group will have 3-6 eligible subjects selected according to the inclusion/exclusion criteria, with a dose of 1.0 × 10^6, 2.0 × 10^6, 3.0 × Increase the dose by 10^6 CAR-T cells/kg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18-75 years old, gender is not limited;
- Understand and know about this study and sign the informed consent voluntarily;
- Patients diagnosed with recurrent/refractory plasma cell blood tumors must: a) have received at least 3 kinds of anti-plasma cell blood tumor therapy, including at least one proteasome inhibitor and one immunomodulator; b) documented progression within 12 months of treatment of the most recent antiplasmacytic blood tumor, or efficacy assessed as SD or PD within 60 days of treatment of the most recent antiplasmacytic blood tumor;
- meet one of the following detection indicators: a) serum M protein ≥5g/L; b) Urine M protein ≥200mg/24h; c) Affected serum free light chain ≥100mg/L and abnormal serum free light chain ratio; d) Bone marrow plasma cell ratio ≥10%;
- ECOG score is 0-2 points; 6, liver and kidney function, cardiopulmonary function meet the following requirements: a) blood creatinine ≤150umol/L, or creatinine clearance (estimated by Cockcroft Gaultra formula) ≥40ml/min (if the kidney function injury caused by rapid progression of the primary disease, the inclusion criteria can be appropriately relaxed, and the decision is made by the investigator); b) Total bilirubin ≤2×ULN; ALT≤3 x ULN, AST≤3 x ULN; c) Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no serious arrhythmias; d) The subjects had no active pulmonary infection, and the blood oxygen saturation of indoor air was > 90%;
Key exclusion criteria (15 listed)
- Have had severe rapid hypersensitivity to any of the drugs to be used in this study;
- History of central nervous system (CNS) diseases, such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy; Known active central nervous system (CNS) involvement or history of modification or clinical signs of multiple myeloma meningeal/spinal meningeal involvement;
- Accompanied by other uncontrolled malignancies (except adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and thyroid cancer after radical surgery);
- The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any grade III (moderate) or grade IV (severe) heart disease (according to the New York Heart Society Functional Grading Method NYHA*); Patients with a history of myocardial infarction, angioplasty or stenting, unstable angina pectoris, or other clinically significant heart disease within 12 months prior to enrollment;
- Previous patients with craniocerebral trauma, cerebrovascular accident, more serious cerebral ischemia or cerebral hemorrhage diseases;
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 |
|---|---|---|
| SENL103Patients will be treated with BCMA CAR-T cells | Biological | BCMA CART |
Primary outcome
To observe the number and incidence of adverse events after intravenous infusion of SENL103.
Time frame: within 1 months after SENL103 infusion.
The number, incidence and severity of all recorded adverse reactions, including cytokine release syndrome and neurotoxicity.
3 secondary outcomes
Efficacy indicators
Time frame: within 3 months after SENL103 infusion.
PD index
Time frame: within 3 months after SENL103 infusion.
PK index
Time frame: within 3 months after SENL103 infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
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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.
Chunrui Li principal investigator
Tongji Hospital
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 SENL103 in people with Multiple Myeloma, run by Hebei Senlang Biotechnology Inc., Ltd. 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 6 inclusion and 15 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 5 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?
Contact Chunrui Li (027-83691785, tongjilunli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the number and incidence of adverse events after intravenous infusion of SENL103. (time frame: within 1 months after SENL103 infusion.). 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 5 Oct 2023.