A Phase 1/2 interventional study of Autologous BCMA-targeting CAR T cells in Multiple Myeloma in Relapse and Multiple Myeloma Refractory, sponsored by Hebei Senlang Biotechnology Inc., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Hebei Senlang Biotechnology Inc., Ltd. · Phase 1/2, Interventional, and Treatment
To Evaluate Safety and Efficacy of S103 for Treating Relapsed or Refractory Multiple Myeloma
This study is a Phase I/II, single-arm, open-label, single-infusion clinical trial designed to evaluate the clinical efficacy and safety of S103 in patients with Relapsed or Refractory Multiple Myeloma
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 24 is below the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Hebei Senlang Biotechnology Inc., Ltd. is the lead sponsor of 40 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1.The subject must understand and voluntarily sign the form (ICF) before any study-related assessments/procedures.; 2.Male or female subjects aged 18 to 70 years (inclusive) at the time of signing the informed consent form; 3. of no less than 12 weeks; 4. performance status of 0 to 1; 5.Diagnosis of multiple myeloma (RRMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, with at least 3 , including regimens based on proteasome inhibitors, immunomodulatory agents, and CD38 monoclonal antibodies; disease progression documented by radiographic evidence within 12 months following the most recent anti-myeloma therapy.; 6.The subject must have measurable multiple myeloma disease, which must meet at least one of the following criteria:
Exclusion Criteria:
1.Subjects with asymptomatic (smoldering) multiple myeloma; 2.Subjects with multiple myeloma with extramedullary lesions (excluding isolated extramedullary lesions with a maximum cross-sectional diameter ≤3 cm)； 3.Subjects with active plasma cell leukemia (defined as peripheral blood plasma cells >5%), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis at screening; 4.Subjects with cardiovascular disease, including any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Autologous BCMA-targeting CAR T cells Biological: BCMA CAR-T; Administration method: intravenous infusion;Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
Biological: Autologous BCMA-targeting CAR T cells
Administration method: intravenous infusion;Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) after S103 infusion
Safety
Time frame: 28 days
Incidence, severity, and relationship of DLTs, AEs and SAEs.
Safety. To evaluate the possible adverse events occurred within 2 years after S103 infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Time frame: 2 years
Pharmacokinetic data parameters.Analysis using CAR DNA copy number measured by qPCR; the highest concentration of S103 cells expanded in peripheral blood after administration
PK.To characterize the in vivo expansion kinetics of S103.
Time frame: 2 years
Pharmacodynamics data parameters. Proportion of BCMA-positive cells and Cytokine release.
PD.To assess the ability of S103 to eliminate BCMA-positive B cells.
Time frame: 2 years
Objective response rate after S103 infusion
Efficacy
Time frame: 3 months
Best overall response after S103 infusion
Effectiveness. Best overall response means the proportion of patients with the best efficacy after S103 cell therapy.
Time frame: 2 years
Duration of Response after S103 infusion
Effectiveness. The time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first
Time frame: 2 years
Progression-Free Survival after S103 infusion
Effectiveness. The time from the initiation of S103 infusion to the first documented disease progression or death from any cause, whichever occurs first.
Time frame: 2 years
Overall survival after S103 infusion
Effectiveness. Overall survival means the time from infusion of S103 cells to death of subjects from any cause.
Time frame: 2 years
Time to Response after S103 infusion
Effectiveness. The time from the initiation of S103 infusion to the first documented objective response.
Time frame: 2 years
MRD-negative ORR at Month 3 post-infusion by flow cytometry
Effectiveness
Time frame: 3 months
MRD-negative ORR at Day-28 post-infusion by flow cytometry.
Effectiveness
Time frame: 28 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hebei Senlang Biotechnology Inc., Ltd. →