QLS32015 / Qilu Pharma - LARVOL DELTA

Updated results of a first-in-human, Phase Ⅰa/Ⅰb study of QLS32015 (GPRC5D×CD3) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) (ASH 2025) - "QLS32015 showed manageable safety profile, with low incidence of GPRC5D-associated TRAEs and nooccurrence of ICANS event. Notably, QLS32015 at RP2D exhibited remarkable preliminary efficacy in ptswith high risk cytogenetics, prior BCMA-targeted therapy, or EMD. The long half-time of 19.8 dayssupports extended dosing intervals of QLS32015 with convenience and compliance."

Clinical • First-in-human • P1 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Pneumonia • Respiratory Diseases • Thrombocytopenia

First-in-Human, Phase Ia, Dose Escalation, Monotherapy Study of QLS32015, a Novel GPRC5D×CD3 T-Cell Engaging Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) (ASH 2024) - P1 | "DLT, MTD, and RP2D were to be determined. Updated safety and efficacy results will be presented."

Clinical • First-in-human • Monotherapy • P1 data • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • GPRC5D

Combination Therapy with QLS32015 for the Treatment of Multiple Myeloma (ChiCTR) - P2 | N=160 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Institute of Hematology

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

QLS32015: A Single-arm Single-center Trial of Bridging GPRC5D/CD3 Bispecific Antibody Treatment With BCMA CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=228 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

Monotherapy • New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Preliminary Results of Qilu Pharmaceutical's Phase Ia Study on GPRC5D/CD3-Targeting Bispecific Antibody QLS32015 Unveiled at 2024 ASH Annual Meeting (PRNewswire) - P1 | N=100 | NCT05920876 | Sponsor: Qilu Pharmaceutical Co., Ltd. | "The findings demonstrated that QLS32015 showed excellent anti-tumor activity and was well tolerated by patients with RRMM....As of August 31, 2024, a total of 13 patients had been enrolled in the trial....In terms of safety, one DLT was observed at the 54 μg/kg dose level, but the MTD was not reached. Treatment-related adverse events (TRAEs) were reported in all patients....As of the data cut-off, 12 out of the 13 enrolled patients had undergone at least one assessment of efficacy. The objective response rate (ORR), assessed according to the International Myeloma Working Group (IMWG) criteria, was 76.9% (10/13). Among these patients, two (15.4%) achieved complete response (CR), three (23.1%) reached very good partial response (VGPR), and five (38.5%) attained partial response (PR)."

P1 data • Multiple Myeloma

A Study of QLS32015 in Patients With Recurrent or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology