Universal BCMA-targeted LUCAR-B68 Cells in Patients With Relapsed/Refractory Multiple Myeloma

NCT05498545 | Not Yet Recruiting Phase 1

• 1 other identifier: BM2L202201
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Universal BCMA-targeted LUCAR-B68 Cells Product in Patients With Relapsed/Refractory Multiple Myeloma

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (5)

• Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

  An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment

  Minimum 2 years after LUCAR-B68 infusion (Day 1

• Dose-limiting toxicity (DLT) rate

  Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose

  Minimum 2 years after LUCAR-B68 infusion (Day 1)

• Recommended Phase 2 dose (RP2D) finding

  RP2D established through ATD+BOIN design

  30 days after LUCAR-B68 infusion (Day 1)

• CAR positive NK cells in peripheral blood and bone marrow

  CAR positive NK cells in peripheral blood and bone marrow after LUCAR-B68 infusion

  Minimum 2 years after LUCAR-B68 infusion (Day 1)

• CAR transgene levels in peripheral blood

  CAR transgene levels in peripheral blood after LUCAR-B68 infusion

  Minimum 2 years after LUCAR-B68 infusion (Day 1)

Secondary Outcomes (6)

• Overall response rate (ORR)

  Minimum 2 years after LUCAR-B68 infusion (Day 1)

• Duration of Response (DOR)

  Minimum 2 years after LUCAR-B68 infusion (Day 1)

• Time to Response (TTR)

  Minimum 2 years after LUCAR-B68 infusion (Day 1)

• Progress Free Survival (PFS)

  2 years after LUCAR-B68 infusion (Day 1)

• Overall Survival (OS)

  Minimum 2 years after LUCAR-B68 infusion (Day 1)

Study Arms (1)

LUCAR-B68 cells product

EXPERIMENTAL

Each subject will receive LUCAR-B68 cells

Biological: LUCAR-B68 cells product

Interventions

LUCAR-B68 cells product BIOLOGICAL

Before treatment with LUCAR-B68 cells, subjects will receive a conditioning regimen

LUCAR-B68 cells product

Eligibility Criteria

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

You may qualify if:

• The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease;
• Subjects ≥ 18 years of age.
• Eastern Cooperative Oncology Group performance status score of 0, 1, or 2;
• Documented initial diagnosis of MM according to IMWG diagnostic criteria.
• Presence of measurable disease at screening.
• Received a PI and an IMiD (except thalidomide).
• Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible.
• Expected survival ≥ 3 months.
• Clinical laboratory values meet screening visit criteria
• Fertile women must be negative using a highly sensitive serum pregnancy test (β human chorionic gonadotropin \[β -HCG\]) at screening time and before initial treatment with cyclophosphamide and fludarabine;

You may not qualify if:

• No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment);
• Prior treatment with any antibody targeting BCMA;
• Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma;
• Serious underlying medical conditions
• Positive of any hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), human immunodeficiency virus antibody (HIV-Ab) at the time of screening;
• Male subjects who have a birth plan during the study period or within 1 year after the study treatment
• Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment
• The investigator considered that the subjects were not suitable for any conditions of participation in the study

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (1)

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

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

Wan-Hong Zhao, PhD

CONTACT

86-29-87679459; zhaowanhong68@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)