OncoMatch/Clinical Trials/NCT05565807
Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Is NCT05565807 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies STI-6129 for relapsed or refractory multiple myeloma.
Treatment: STI-6129 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed/refractory after the most recent anti-MM therapy.
Must have received: immunomodulatory drug
Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed/refractory after the most recent anti-MM therapy.
Must have received: anti-CD38 antibody
Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed/refractory after the most recent anti-MM therapy.
Cannot have received: plasma exchange therapy
Had received plasma exchange therapy within 28 days before the first administration of the study drug.
Cannot have received: monoclonal antibody
Had received...monoclonal antibody...within 28 days
Cannot have received: cytotoxic drug
Had received...cytotoxic drug...within 28 days
Cannot have received: radiation therapy
Had received...radiotherapy within 28 days
Cannot have received: immunoregulator
Had received...immunoregulator...within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: targeted therapy
Had received...targeted therapy...within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: epigenetic therapy
Had received...epigenetic therapy...within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: investigational medical product
Had received...investigational medical product...within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: invasive investigational medical device
Had received...invasive investigational medical device...within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: other anti-myeloma therapy
Had received...other anti-myeloma therapy within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: proteasome inhibitor
Had received...proteasome inhibitor...within 14 days
Cannot have received: anti-tumor traditional Chinese medicine treatment
Had received...anti-tumor traditional Chinese medicine treatment...within 14 days
Cannot have received: corticosteroids
Exception: 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
Had received...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
Cannot have received: CAR-T cell therapy
Had received CAR-T therapy...within 6 months before the first administration of the study drug
Cannot have received: allogeneic hematopoietic stem cell transplantation
Had received...allogeneic hematopoietic stem cell transplantation therapy within 6 months before the first administration of the study drug
Cannot have received: autologous hematopoietic stem cell transplantation
Had received autologous hematopoietic stem cell transplantation within 12 weeks before the first administration of the study drug
Lab requirements
Blood counts
Hemoglobin <80g/L, Platelet count <50×10^9/L, Absolute neutrophil count <1.0×10^9/L excluded
Kidney function
Estimated creatinine clearance <30mL/min excluded
Liver function
AST or ALT >3×upper limit of normal (ULN) or serum total bilirubin > 1.5×ULN excluded
Cardiac function
NYHA class >2, unstable angina, MI within 6 months, poorly controlled arrhythmias, QTcF >470msec, LVEF <40%, poorly controlled hypertension, stroke/cerebrovascular accident/TIA within 6 months excluded
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. 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. 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05565807 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior plasma exchange therapy, monoclonal antibody, cytotoxic drug disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages