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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma

A Phase Ib/IIa, Open-Label, Dose-Escalation and Extension Study to Evaluate the Safety and Efficacy of An Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Multiple Myeloma

Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma (NCT05565807) is a Phase 1 / Phase 2 interventional studying Relapsed or Refractory Multiple Myeloma, sponsored by Zhejiang ACEA Pharmaceutical Co. Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a phase Ib/IIa, open-label, dose-escalation, and extension study to evaluate the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory multiple myeloma.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Relapsed or Refractory Multiple Myeloma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 84 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Relapsed or Refractory Multiple Myeloma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥18 years old, regardless of gender. 2. Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed/refractory after the most recent anti-MM therapy. 3. Diagnosis of MM according to IMWG criteria with measurable lesions, meeting at least 1 of the following criteria: - Serum M protein ≥ 0.5g/dL (≥ 5 g/L); or - Urine M protein ≥ 200mg/24 hours; or - When the serum free light chain (FLC) ratio is abnormal, the affected FLC level is ≥10mg/dL (≥100 mg/L) (the normal FLC ratio is 0.26 to 1.65). 4. ECOG performance status score is 0, 1, or 2. 5. Willing and able to comply with the study schedule and all other study protocol requirements. 6. Women of childbearing potential (WOCBP) (infertile women are defined as sexually mature females who had undergone a hysterectomy or bilateral oophorectomy or bilateral salpingectomy or bilateral tubal ligation/closure, or who are infertile due to a congenital or acquired condition or spontaneously menopausal for ≥ 12 months) must have a negative blood pregnancy test during the screening. Female subjects of childbearing potential and male subjects with fertility must use a highly effective method of contraception from screening to 6 months after the last treatment. Who Should NOT Join This Trial: 1. Known hypersensitivity to any of the ingredients of this product. 2. Diagnosis of active plasma cell leukemia. 3. Diagnosis of systemic light chain amyloidosis. 4. MM involving the central nervous system. 5. Has POEMS syndrome. 6. There is spinal cord compression associated with MM. 7. Needs to take concomitant drugs with a strong inhibitory effect or a strong induction effect on CYP3A4. 8. Had received plasma exchange therapy within 28 days before the first administration of the study drug. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age ≥18 years old, regardless of gender. 2. Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed/refractory after the most recent anti-MM therapy. 3. Diagnosis of MM according to IMWG criteria with measurable lesions, meeting at least 1 of the following criteria: * Serum M protein ≥ 0.5g/dL (≥ 5 g/L); or * Urine M protein ≥ 200mg/24 hours; or * When the serum free light chain (FLC) ratio is abnormal, the affected FLC level is ≥10mg/dL (≥100 mg/L) (the normal FLC ratio is 0.26 to 1.65). 4. ECOG performance status score is 0, 1, or 2. 5. Willing and able to comply with the study schedule and all other study protocol requirements. 6. Women of childbearing potential (WOCBP) (infertile women are defined as sexually mature females who had undergone a hysterectomy or bilateral oophorectomy or bilateral salpingectomy or bilateral tubal ligation/closure, or who are infertile due to a congenital or acquired condition or spontaneously menopausal for ≥ 12 months) must have a negative blood pregnancy test during the screening. Female subjects of childbearing potential and male subjects with fertility must use a highly effective method of contraception from screening to 6 months after the last treatment. Exclusion Criteria: 1. Known hypersensitivity to any of the ingredients of this product. 2. Diagnosis of active plasma cell leukemia. 3. Diagnosis of systemic light chain amyloidosis. 4. MM involving the central nervous system. 5. Has POEMS syndrome. 6. There is spinal cord compression associated with MM. 7. Needs to take concomitant drugs with a strong inhibitory effect or a strong induction effect on CYP3A4. 8. Had received plasma exchange therapy within 28 days before the first administration of the study drug. 9. Had received the following anti-tumor treatments before the first administration of the study drug: monoclonal antibody or cytotoxic drug or radiotherapy within 28 days; immunoregulator, targeted therapy or epigenetic therapy or investigational medical product or invasive investigational medical device or other anti-myeloma therapy within 28 days or 5 half-lives (whichever is shorter); proteasome inhibitor or anti-tumor traditional Chinese medicine treatment or corticosteroids with a cumulative dose of more than 140 mg prednisone (or equivalent) or a single dose of more than 40 mg/day dexamethasone (or equivalent) within 14 days. 10. Had received CAR-T therapy or allogeneic hematopoietic stem cell transplantation therapy within 6 months before the first administration of the study drug, or have a concomitant disease of active graft-versus-host disease (GvHD) at screening. 11. Had received autologous hematopoietic stem cell transplantation within 12 weeks before the first administration of the study drug. 12. Had undergone major surgery or eye surgery within 28 days before the first administration of the study drug. 13. Other malignant diseases within 3 years before the first administration of the study drug. 14. History of grade ≥3 (muscle paralysis, eyelid disease, glaucoma requiring drug control, tearing eyes), or grade ≥2 any other ocular disease (as judged by NCI-CTCAE version 5.0) at screening. 15. Has ≥ Grade 3 neuropathy or Grade 2 neuropathy with associated pain. 16. The toxicity caused by the previous anti-tumor treatment did not subside to ≤ grade 1. 17. Has the following hematological test results within 7 days before the first administration of the study drug: 1. Hemoglobin \<80g/L 2. Platelet count \<50×10\^9/L 3. Absolute neutrophil count \<1.0×10\^9/L 18. Has the following blood chemistry test results within 7 days before the first administration of the study drug: 1. Estimated creatinine clearance \<30mL/min. 2. AST or ALT\>3×upper limit of normal (ULN) or serum total bilirubin\> 1.5×ULN. 19. Severe or uncontrolled cardiovascular and cerebrovascular diseases requiring treatment, including: 1. New York Heart Association class\>2; 2. Unstable angina pectoris that cannot be controlled by drugs; 3. Myocardial infarction occurred within 6 months before the first administration of the study drug; 4. Poorly controlled arrhythmias; 5. 12-lead ECG QTcF\>470msec; 6. Left ventricular ejection fraction \<40%; 7. Poorly controlled hypertension ; 8. Stroke, cerebrovascular accident, or transient ischemic attack occurred within 6 months before the first administration of the study drug. 20. Meets any of the following criteria: 1. Known chronic obstructive pulmonary disease (COPD) and forced expiratory volume in 1 second (FEV1) \<50% of predicted normal; 2. Known moderate or severe persistent asthma, or a history of asthma within the past 2 years, or current uncontrolled asthma of any classification; 3. with interstitial lung disease requiring corticosteroid therapy, drug-induced interstitial lung disease, a history of radiation pneumonitis, orclinically active interstitial lung disease suggested by any current evidence before the first administration of the study drug. 21. Has an active bacterial, viral, or fungal infection or needs for intravenous antibiotic administration (IV) within 72 hours before the first administration of the study drug. 22. Active or uncontrolled HBV , HCV , HIV positive. 23. Is currently pregnant or breast feeding. 24. Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.

Treatments Being Tested

BIOLOGICAL

STI-6129

Anti-CD38 A2 human antibody drug conjugate (ADC) containing an antibody covalently bound to a duostatin tubulin inhibitor.

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Chao-Yang Hospital,Capital Medicine University
Beijing, Beijing Municipality, China
Peking university Third hospital
Beijing, Beijing Municipality, China
The first affiliated hospital ,Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05565807), the sponsor (Zhejiang ACEA Pharmaceutical Co. Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05565807 clinical trial studying?

This is a phase Ib/IIa, open-label, dose-escalation, and extension study to evaluate the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory multiple myeloma. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05565807?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05565807?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05565807. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05565807. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.