A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma

This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.

Study Overview

• Status: Recruiting
• Conditions: Relapsed or Refractory Multiple Myeloma
• Intervention / Treatment: Drug: F182112+P; Drug: F182112+CD38

Detailed Description

The study plans to enroll approximately 90 patients with relapsed or refractory multiple myeloma at around 20 study centers.

Primary objective:

The objective response rate (ORR) of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.

Secondary objective:

The efficacy of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma (complete response rate [CRR], progression - free survival [PFS], overall survival [OS], duration of response [DOR], time to response [TTR], time to progression [TTP], minimal residual disease - negative rate); The incidence and grade of adverse events (AE), serious adverse events (SAE), abnormal laboratory test indicators.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lu gui Qiu Doctor; Phone Number: (+86)13821266636; Email: Qiulg@ihcams.ac.cn
• Study Contact Backup: Name: Shaohong Yin; Email: yinshaohong@vip.lunan.cn

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Institute of Hematology & Blood Diseases Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be diagnosed with multiple myeloma according to the IMWG 2016 criteria.
• The previous treatment regimen must contain lenalidomide (lenalidomide must be used continuously for at least 2 cycles) and a proteasome inhibitor.
• Participants whose previous treatment regimen contained pomalidomide or who were intolerant to pomalidomide cannot be enrolled.
• Have an ECOG performance status score of 0 - 2.

• Meet at least one of the following measurable disease indicators:

  1. Serum M - protein ≥ 5 g/L.
  2. Urine M - protein ≥ 200 mg/24 h.
  3. Serum free light chain (FLC) test: Involved FLC level ≥ 100 mg/L and abnormal serum free light chain ratio (< 0.26 or > 1.65).

Exclusion Criteria:

• Patients with primary light - chain amyloidosis or plasma cell leukemia .
• Patients with symptoms of central nervous system involvement of multiple myeloma.
• Patients with a history of other malignancies other than multiple myeloma within 3 years before the first dose.
• Patients with active mucosal or visceral bleeding.
• Patients who have previously received BCMA - targeted therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F182112 combined with different administration regimens	Drug: F182112+P; F182112 + P; Other Names: Pomalidomide; F182112; Drug: F182112+CD38; F182112+CD38; Other Names: CD38 monoclonal antibody; F182112; BCMA CD3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR)	up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression - Free Survival（PFS）	Up to 2 years
Minimal Residual Disease - negative rate	Up to 2 years
Number of Participants With Adverse Events and Serious Adverse Events	Up to 2 years
Overall Survival（OS）	Up to 2 years
Duration of Response（DOR）	up to 2 years

Collaborators and Investigators

• Sponsor: Shandong New Time Pharmaceutical Co., LTD

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2025
• Primary Completion (Estimated): May 20, 2028
• Study Completion (Estimated): May 20, 2028

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Multiple Myeloma; pomalidomide
• Other Study ID Numbers: NTP-F182112-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No