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

NCT07312188 | Recruiting Phase 2

• 1 other identifier: NTP-F182112-101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  up to 2 years

Secondary Outcomes (5)

• 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

Study Arms (1)

F182112 combined with different administration regimens

EXPERIMENTAL

F182112 combined with different administration regimens

Drug: F182112+P; Drug: F182112+CD38

Interventions

F182112+P DRUG

F182112 + P

Also known as: F182112, Pomalidomide

F182112 combined with different administration regimens

F182112+CD38 DRUG

F182112+CD38

Also known as: F182112, BCMA CD3, CD38 monoclonal antibody

F182112 combined with different administration regimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

pomalidomide

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Lu gui Qiu Doctor

CONTACT

（+86）13821266636; Qiulg@ihcams.ac.cn

Shaohong Yin

CONTACT

yinshaohong@vip.lunan.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: December 31, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): May 20, 2028
• Study Completion (Estimated): May 20, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)