A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

NCT06644118 | Recruiting Phase 1

• 1 other identifier: OL-101-001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial aims to characterize the safety of OL-101 and establish the recommended dose for future research and to evaluate the efficacy of OL-101 (Dose expansion).

Conditions

Multiple Myeloma

Keywords

OL-101; Multiple myeloma; Phase 1; single arm

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Adverse events will be assessed based on the CTCAE 5.0

  Within 28 days post CAR-T infusion

• Treatment emergent adverse event (TEAE) incidence and severity

  Adverse events will be assessed based on the CTCAE 5.0

  From aphresis till 1 year after CAR-T infusion or start of a new anti-cancer therapy, whichever is earlier

Secondary Outcomes (12)

• Level of Immunogenicity

  Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first

• Level of RCL

  Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first

• Overall response rate (ORR)

  Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first

• Minimal residual disease (MRD) negative rate

  Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first

• Duration of response (DOR)

  Baseline until 2 years after CAR-T infusion or withdrawn from the study, whichever comes first

Study Arms (1)

OL-101 infusion

EXPERIMENTAL

This arm provides CAR-T treatment at the dose the patient is assigned to.

Biological: OL-101 infusion

Interventions

OL-101 infusion BIOLOGICAL

OL-101 infusion will be administered to patients via IV infusion at the assigned dose.

OL-101 infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic criteria
• Relapsed/refractory multiple myeloma as defined by:
• \) Received at least 3 prior lines of MM treatment (must include a PI, an IMiD, and an anti-CD38 antibody).
• ）Disease progression within 12 months of the most recent anti-MM therapy; or disease progression within the past 6 months and subsequently lack response to the most recent line of therapy.
• Measurable disease at screening as defined by any of the following:
• Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
• Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
• Positive expression of either BCMA or GPRC5D on bone marrow plasma cells; must be GPRC5D expression positive if previously received BCMA targeted therapy
• ECOG 0-1
• Expected life expectancy exceeds 12 weeks
• Adequate bone marrow reserve or organ function meeting the following criteria:
• Hemoglobin ≥ 70 g/L
• Platelet count ≥ 50 × 10\^9/L
• Absolute lymphocyte count ≥ 0.3×10\^9/L
• Absolute neutrophil count ≥ 1.0 × 10\^9/L

You may not qualify if:

• Solitary plasmacytoma
• Known active central nervous system (CNS) involvement or exhibits clinical signs of CNS involvement of multiple myeloma.
• Received allogeneic stem cell transplant; received autologous stem cell transplant within 12 weeks before screening
• Active second primary malignant tumor, exclude the following: cured non- melanoma skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or lobular carcinoma in situ of the breast
• Any other significant medical disease, abnormality, or condition that, in the investigator judgment, may make the patient unsuitable for participation in the study or put the patient at risk.
• Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.

Sponsors & Collaborators

• Zhejiang University: lead
• Overland Therapeutics: collaborator

Study Sites (3)

Beijing Gobroad Boren Hospital

Beijing, Beijing Municipality, 100071, China

NOT YET RECRUITING

The Affiliated Hospital of Northwest University Xi'an No.3 Hospital

Xi’an, Shanxi, 710016, China

NOT YET RECRUITING

The first affiliated hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 3100003, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

He Huang, MD, PhD

CONTACT

(+86)13605714822; hehuangyu@126.com

Yongxian Hu, MD, PhD

CONTACT

(+86)15957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 16, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)