Relapsed or Refractory Multiple MyelomaPhase 1NCT06574568
A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing YKST02 in people with Relapsed or Refractory Multiple Myeloma, run by Excyte Biopharma Ltd at 12 sites in China.
Trial summary
This study aims to provide a basis for further clinical development of YKST02. YKST02 is a study medicine that targets multiple myeloma and activates the human body to fight against this disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- YKST02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 12 sitesChina
- Study dates
- 14 Jun 2024to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study.
- Diagnosis of multiple myeloma according to the IMWG criteria.
- Receipt of at least two prior classes of drugs either in separate regimens or as combinations. The three classes are defined as: An immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug.
- Measurable disease at screening, as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL;
- Urinary M-protein excretion ≥200 mg/24 hours;
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- Abnormal serum free light chain (FLC) ratio ( <0.26 or >1.65) and serum immunoglobulin FLC≥10 mg/dL.
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1.
- An estimated survival time of more than 12 weeks.
- Recovery to Grade 0-1 (Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0) from adverse events related to prior therapy except alopecia.
- Adequate hematological and organ function.
- Female participants of childbearing potential must have a negative serum pregnancy test at screening. Female patients who are sexually active must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
- Male participants must agree to use reliable methods of contraception (barrier methods or sexual abstinence) and avoid sperm donation throughout the study period and until 3 months after the last dose.
Who cannot join
- Plasma cell leukemia (>2.0×10^9/L plasma cells by standard differential), Waldenstrom's Macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary light-chain amyloidosis.
- History of antitumor therapy as follows, before the first dose of study drug:
- Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer;
- Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 2 weeks;
- Chemotherapy within 2 weeks;
- Treatment with an investigational drug within 2 weeks or 5 half-lives, whichever is shorter;
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- Radical/extensive radiotherapy within 4 weeks, or local palliative radiotherapy within 2 weeks, or acute toxicity induced by previous radiotherapy have not recovered to grade ≤1;
- Autologous stem cell transplantation within 12 weeks;
- History of organ transplant, or allogeneic stem cell transplantation within 6 months;
- Prior treatment with any B cell maturation antigen (BCMA) targeted therapy;
- Prior treatment with any BCMA targeted chimeric antigen receptor modified [CAR]-T cells therapy.
- Any active acute graft-versus-host disease (GvHD), grade 2-4 (according to Glucksberg criteria) or active chronic GvHD requiring systemic treatment within 2 weeks.
- Prior myelodysplastic syndrome or malignancy within 5 years, except for localized malignancies that have been adequately treated or free of the disease for ≥ 5 years, e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast.
- Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the investigator.
- (a) History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis; (b) Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI.
- History or evidence of cardiovascular disease, including:
- Acute coronary syndromes (eg, myocardial infarction, unstable angina) within 6 months prior to enrollment;
- Coronary angioplasty or stenting within 6 months prior to enrollment;
- Clinically significant unstable arrhythmias (eg, atrial fibrillation), however, atrial fibrillation has been controlled for over 30 days prior to the first dose of YKST02 were allowed;
- New York Heart Association (NYHA) stage III or higher congestive heart failure within 6 months prior to enrollment; Cardiac valve morphological abnormalities recorded by ECHO (≥ grade 2), note that grade 1 cardiac valve morphological abnormalities (such as mild regurgitation/stenosis) were allowed, but participants with moderate valve thickening were excluded;
- Left ventricular ejection fraction (LVEF) below lower limit of the study center, or LVEF<50% if there is no lower limit at the study center;
- The Fridericia-corrected QT interval (QTcF) ≥ 470 msec (female) or ≥ 450 msec (male)；
- Implantable defibrillator;
- Clinically uncontrollable hypertension (i.e., SBP≥160 mm Hg and/or DBP≥100 mm Hg).
- Known allergy to monoclonal antibody drugs or exogenous immunoglobulin.
- Any major organ surgery or significant trauma within 4 weeks prior to the first dose of YKST02, or those requiring elective surgeries during the study, and all AEs associated with surgery or significant trauma have not recovered before the first dose of the YKST02.
- Regular dose of systemic corticosteroids during 4 weeks prior to initiation of study drug, or anticipated need of corticosteroids exceeding prednisone 20 mg/day or equivalent during the trial, or any other systemic immunosuppressive therapy within 4 weeks prior to study entry.
- Virological tests: Hepatitis B virus surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) quantitative >ULN of the testing institution; Hepatitis C antibody (HCV-Ab) positive and hepatitis C virus-RNA (HCV-RNA) quantitative > ULN of the testing institution; Anti-human immunodeficiency virus (Anti-HIV) positive. Participants will be excluded from the study if any of the above criteria is met.
- Uncontrolled active infections requiring oral or intravenous systemic therapy, except for local treatment.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).
- Pregnant or lactating women.
- Known mental disorder that may affect study compliance or poor compliance.
- Receipt of any live attenuated vaccines or live virus vaccine within 4 weeks prior to the first dose of study treatment.
- Other serious systemic diseases or laboratory abnormalities or other reasons that the investigator believes are not appropriate for participating the study.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100024
Wenming Chen, MD, +86-13910107759, 13910107759@163.com
- Recruiting
Beijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100035
Li Bao
- Recruiting
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
Meiyun Fang
Xiang Li
- Recruiting
Shunde Hospital of Southern Medical University
Foshan, Guangdong, 528308
Lan Deng, MD
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhongjun Xia
- Not yet recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510289
Jie Xiao
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jie Jin, MD
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Aichun Liu
- Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Lijie Xing
Qi Dang, MM
- Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Xiaohong Tan, MD
- Not yet recruiting
Shanxi Cancer hospital
Taiyuan, Shanxi, 030013
Liping Su, MD
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Baijun Fang, MD
About this study
Official title: A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma
This study aims to provide a basis for further clinical development of YKST02. YKST02 is a study medicine that targets multiple myeloma and activates the human body to fight against this disease.
Read the detailed description
This study is the first-in-human clinical trial to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary efficacy of YKST02 in patients with relapsed or refractory multiple myeloma (MM). Multiple Myeloma (MM) is a cancer of the blood's plasma cells (blood cell). YKST02 is a bispecific antibody bridging CD3-expressing T cells and BCMA-expressing multiple myeloma cells to induce T cells-mediated cytotoxicity. This study consists of dose escalation phase and dose expansion phase.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- YKST02
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YKST02Drug
Also called YKST02 for Injection
BCMA-CD3 bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| YKST02 | Experimental | Participants will receive different doses of YKST02 in 21-day cycles via intravenous injection. Receives: Drug: YKST02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-limiting Toxicities (DLT)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
Measured: 21 days after the first dose
Incidence of Adverse Events (AEs)
An AE is defined as any untoward medical event that occurs after a subject receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
Measured: up to 42 weeks
Incidence of Serious Adverse Events (SAEs)
A SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the subject receives the investigational drug, and congenital abnormalities or birth defects.
Measured: up to 42 weeks
Overall Response Rate (ORR)
Measured by IMWG criteria, only applicable in dose expansion phase
Measured: From the date of dosing until the date of first documented progression
Secondary outcomes (9)
Area under the Concentration-time Curve (AUC) after Administration
AUC of YKST02
Measured: up to 42 weeks
Maximum Serum Concentration (Cmax) of YKST02
Cmax is defined as the maximum observed serum concentration of YKST02
Measured: up to 42 weeks
Time to Cmax of YKST02 (Tmax)
Time to maximum serum concentration (Tmax) of YKST02
Measured: up to 42 weeks
Terminal Half-life (T1/2) of YKST02
Terminal Half-life (T1/2) of YKST02
Measured: up to 42 weeks
Percentage of Participants with Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) Against YKST02
Assess the percentage of participants with ADA and Nab (only assessed when ADA positive) after treatment with YKST02.
Measured: up to 42 weeks
ORR
Measured by IMWG criteria, only applicable in dose escalation phase
Measured: From the date of dosing until the date of first documented progression
Progression-free Survival (PFS)
Evaluation of the efficacy of YKST02 in patients with MM on progression-free survival
Measured: From the date of dosing until the date of first documented progression
Overall survival (OS)
Overall survival (OS) was defined as the time from the date of first dose until death due to any cause.
Measured: From the date of first dose until loss of follow-up, death, withdrawal of informed consent, or the end of study, whichever occurs first
Minimal Residual Disease (MRD) Negativity Rate
MRD negativity rate was the percentage of participants with CR/sCR and negative MRD.
Measured: From start of treatment to end of the study (approximately 42 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start14 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Excyte Biopharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenming Chen, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574568
- Sponsor's protocol ID
- YKST02-I-01
- Status last verified
- Feb 2026
- First submitted
- 26 Aug 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06574568
- Acronym / sponsor ID
- YKST02-I-01
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Excyte Biopharma LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Aug 2024 (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 study aims to provide a basis for further clinical development of YKST02. YKST02 is a study medicine that targets multiple myeloma and activates the human body to fight against this disease.
Detailed description
This study is the first-in-human clinical trial to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary efficacy of YKST02 in patients with relapsed or refractory multiple myeloma (MM). Multiple Myeloma (MM) is a cancer of the blood's plasma cells (blood cell). YKST02 is a bispecific antibody bridging CD3-expressing T cells and BCMA-expressing multiple myeloma cells to induce T cells-mediated cytotoxicity. This study consists of dose escalation phase and dose expansion phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YKST02 | Experimental | Drug: YKST02Participants will receive different doses of YKST02 in 21-day cycles via intravenous injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study.
- Diagnosis of multiple myeloma according to the IMWG criteria.
- Receipt of at least two prior classes of drugs either in separate regimens or as combinations. The three classes are defined as: An immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug.
- Measurable disease at screening, as defined by at least 1 of the following:
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1.
Key exclusion criteria (34 listed)
- Plasma cell leukemia (>2.0×10^9/L plasma cells by standard differential), Waldenstrom's Macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary light-chain amyloidosis.
- History of antitumor therapy as follows, before the first dose of study drug:
- Any active acute graft-versus-host disease (GvHD), grade 2-4 (according to Glucksberg criteria) or active chronic GvHD requiring systemic treatment within 2 weeks.
- Prior myelodysplastic syndrome or malignancy within 5 years, except for localized malignancies that have been adequately treated or free of the disease for ≥ 5 years, e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast.
- Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the investigator.
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 |
|---|---|---|
| YKST02Also: YKST02 for InjectionBCMA-CD3 bispecific antibody | Drug | YKST02 |
Primary outcome
Number of Participants with Dose-limiting Toxicities (DLT)
Time frame: 21 days after the first dose
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
Incidence of Adverse Events (AEs)
Time frame: up to 42 weeks
An AE is defined as any untoward medical event that occurs after a subject receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
Incidence of Serious Adverse Events (SAEs)
Time frame: up to 42 weeks
A SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the subject receives the investigational drug, and congenital abnormalities or birth defects.
Overall Response Rate (ORR)
Time frame: From the date of dosing until the date of first documented progression
Measured by IMWG criteria, only applicable in dose expansion phase
9 secondary outcomes
Area under the Concentration-time Curve (AUC) after Administration
Time frame: up to 42 weeks
Maximum Serum Concentration (Cmax) of YKST02
Time frame: up to 42 weeks
Time to Cmax of YKST02 (Tmax)
Time frame: up to 42 weeks
Terminal Half-life (T1/2) of YKST02
Time frame: up to 42 weeks
Percentage of Participants with Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) Against YKST02
Time frame: up to 42 weeks
ORR
Time frame: From the date of dosing until the date of first documented progression
Progression-free Survival (PFS)
Time frame: From the date of dosing until the date of first documented progression
Overall survival (OS)
Time frame: From the date of first dose until loss of follow-up, death, withdrawal of informed consent, or the end of study, whichever occurs first
Minimal Residual Disease (MRD) Negativity Rate
Time frame: From start of treatment to end of the study (approximately 42 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
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Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse
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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.
Wenming Chen, MD principal investigator
Beijing Chao Yang Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YKST02 in people with Relapsed or Refractory Multiple Myeloma, run by Excyte Biopharma Ltd at 12 sites 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 13 inclusion and 34 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenming Chen, MD (+86-13910107759, 13910107759@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 with Dose-limiting Toxicities (DLT) (time frame: 21 days after the first dose). The study lists 4 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 5 Feb 2026.