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

NCT ID: NCT06644118

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-23
• Study Completion Date: 2028-10-31

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).

Detailed Description

This study will evaluate the safety and efficacy of OL-101, a chimeric antigen receptor T cell (CAR-T) therapy directed against B-Cell Maturation Antigen (BCMA) and G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D). This study is a single-arm, open-label, early exploratory clinical trial, conducted in two phases: dose escalation and dose expansion in adults with multiple myeloma. The trial begins with the dose-escalation phase that focus on safety and tolerability, with interval assessments for potential dose escalation or de-escalation. Recommended dose will be selected at the completion of the dose escalation stage in the dose expansion stage. The study aims to assess safety, pharmacokinetic/pharmacodynamic profiles, and efficacy.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OL-101 infusion

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

Group Type: EXPERIMENTAL

OL-101 infusion

Intervention Type: BIOLOGICAL

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

Interventions

OL-101 infusion

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic criteria
• Relapsed/refractory multiple myeloma as defined by:

1) Received at least 3 prior lines of MM treatment (must include a PI, an IMiD, and an anti-CD38 antibody).

2）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:

1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or

2. 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:

1. Hemoglobin ≥ 70 g/L

2. Platelet count ≥ 50 × 10^9/L

3. Absolute lymphocyte count ≥ 0.3×10^9/L

4. Absolute neutrophil count ≥ 1.0 × 10^9/L

5. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN)

6. Total bilirubin ≤ 2 times ULN; except in subjects with congenital bilirubinemia (such as Gilbert syndrome, in which case the direct bilirubin ≤1.5 × ULN is required)

7. Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault equation).

8. corrected serum calcium ≤12.5 mg/dL (≤3.1 mmol/L) or free ionized calcium ≤6.5 mg/dl (≤1.6 mmol/L)

9. SpO2>92% on room air

10. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram; no clinically meaningful pericardial effusion by ultrasound

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Overland Therapeutics

UNKNOWN

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Gobroad Boren Hospital

Beijing, Beijing Municipality, China

Site Status: NOT_YET_RECRUITING

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

Xi’an, Shanxi, China

Site Status: NOT_YET_RECRUITING

The first affiliated hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, MD, PhD

Role: CONTACT

hehuangyu@126.com

(+86)13605714822

Yongxian Hu, MD, PhD

Role: CONTACT

huyongxian2000@aliyun.com

(+86)15957162012

Facility Contacts

Xiequn Chen, MD, PHD

Role: primary

20203009@nwu.edu.cn

(+86)13991832567

Xiequn Chen, MD, PHD

Role: backup

Yajin Zhang, MD, PHD

Role: primary

zhangyj3@gobroadhealthcare.com

(+86)18601333856

Yajin Zhang, MD, PHD

Role: backup

He Huang, MD, PhD

Role: primary

hehuangyu@126.com

(+86)13605714822

Other Identifiers

OL-101-001

Identifier Type: -

Identifier Source: org_study_id