A Single-center Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of a BCMA-targeted Universal LCAR-BCX Cells in Patients With Relapsed/Refractory Multiple Myeloma

NCT04601935 | Unknown Phase 1

• 1 other identifier: BM2L202004
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm, single-center, open-label dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCX cells in subjects with relapsed/refractory multiple myeloma

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Within 30 days after cells infusion

Secondary Outcomes (1)

• Overall Response Rate (ORR)

  Two years after infusion to the last subject

Study Arms (1)

LCAR-BCX cells product

EXPERIMENTAL

Each subject will be given a single-dose infusion in each dose levelThe dose-finding phase of this study is designed primarily using the Bayesian optimal interval (BOIN) method, which is combined with accelerated titration at the beginning of the study to assess incidence of DLT (dose-limiting toxicity) and estimate MTD (maximum tolerated dose).

Biological: LCAR-BCX cells product

Interventions

LCAR-BCX cells product BIOLOGICAL

In this study, LCAR-BCX CAR+ cells will be evaluated at 5 dose levels including 0.25 × 10\^6 cells/kg, 0.5 × 10\^6 cells/kg, 1.0 × 10\^6 cells/kg, 2.0 × 10\^6 cells/kg, and 4.0 × 10\^6 cells/kg, with 0.25 × 10\^6 cells/kg as the starting dose, to determine RP2D for LCAR-BCX cell therapy

LCAR-BCX cells product

Eligibility Criteria

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

You may qualify if:

• Subject is willing to participate in the clinical study; fully understands and informed the study contents, and signs the informed consent form.
• Chinese subjects ≥ 18 years of age.
• 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.

You may not qualify if:

• No response to prior BCMA-targeted CAR-T therapy (except for subjects who relapsed after CR to prior CAR-T therapy).
• Prior treatment with any BCMA-targeted monoclonal antibody.
• Diagnosed or previously treated for other invasive malignancies other than multiple myeloma, with the following exceptions:
• Malignancies treated with curative intent and with no known active disease present for ≥ 2 years before enrollment; or
• Adequately treated non-melanoma skin cancer without current evidence of disease.
• Prior anti-tumor therapies as follows (prior to conditioning):
• Monoclonal antibody treatment for multiple myeloma within 21 days
• Targeted therapy, epigenetic therapy, or treatment with an investigational product, or used an invasive investigational medical device within 14 days or at least 5 half-lives (whichever is less)
• Cytotoxic therapy within 14 days
• Proteasome inhibitor therapy within 14 days
• Radiotherapy within 14 days. However, if the radiation field covers ≤ 5% of bone marrow reserve, the subject is eligible to participate in the study regardless of the end date of radiaotherapy
• Immunomodulatory agent therapy within 7 days.
• Occurrence of the following cardiac disorders:
• NYHA stage III or IV congestive heart failure
• Myocardial infarction or coronary artery bypass graft (CABG) ≤ 6 months prior to enrollment

Sponsors & Collaborators

• Weijun Fu: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Hematology Department

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 26, 2020
• Study Start: October 9, 2020
• Primary Completion: January 1, 2023
• Study Completion: October 1, 2024
• Last Updated: November 2, 2021

Record last verified: 2021-11

Locations

CN (1)