Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Recruiting
Phase 1Phase 2Interventional Study
Relapsed or Refractory Multiple Myeloma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
Zhejiang ACEA Pharmaceutical Co. Ltd. · Industry
Who this trial is looking for
This trial is looking for adults with relapsed or refractory multiple myeloma who have previously undergone treatment. Participants will receive a new form of treatment to help fight their cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been treated with at least three different cancer drugs.
I have relapsed or my cancer has not responded to the last treatment.
I have measurable lesions from my cancer.
I have an ECOG performance status score of 0, 1, or 2.
I am able to follow the study schedule and requirements.
I am a woman of childbearing potential and have a negative pregnancy test.
I will use effective birth control during the study.
You may not be able to join if
I am allergic to any ingredient in the study drug.
I have active plasma cell leukemia.
I have systemic light chain amyloidosis.
I have multiple myeloma in my central nervous system.
I have spinal cord compression due to multiple myeloma.
I have had any treatment for cancer within the last 28 days.
I have had any major surgery within the last 28 days.
I am currently pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
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…
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.
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