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

Recruiting now · Phase 1/Phase 2

Conditions studied: Relapsed or Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT05565807
Run by: Zhejiang ACEA Pharmaceutical Co. Ltd.
People needed: 84
Starts: 2023-02-09
Expected to finish: 2028-02-19
Last updated by the study team: 2025-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 years old, regardless of gender.
Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed/refractory after the most recent anti-MM therapy.
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).
ECOG performance status score is 0, 1, or 2.
Willing and able to comply with the study schedule and all other study protocol requirements.
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.

You may not qualify if…

Known hypersensitivity to any of the ingredients of this product.
Diagnosis of active plasma cell leukemia.
Diagnosis of systemic light chain amyloidosis.
MM involving the central nervous system.
Has POEMS syndrome.
There is spinal cord compression associated with MM.
Needs to take concomitant drugs with a strong inhibitory effect or a strong induction effect on CYP3A4.
Had received plasma exchange therapy within 28 days before the first administration of the study drug.
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.
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.
Had received autologous hematopoietic stem cell transplantation within 12 weeks before the first administration of the study drug.
Had undergone major surgery or eye surgery within 28 days before the first administration of the study drug.
Other malignant diseases within 3 years before the first administration of the study drug.
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.
Has ≥ Grade 3 neuropathy or Grade 2 neuropathy with associated pain.
The toxicity caused by the previous anti-tumor treatment did not subside to ≤ grade 1.
Has the following hematological test results within 7 days before the first administration of the study drug:
Hemoglobin <80g/L
Platelet count <50×10\^9/L
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:
Estimated creatinine clearance <30mL/min.
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:
New York Heart Association class>2;

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.