- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05376345
BCMA-targeted LCAR-BCDR Cells in Patients With Relapsed/Refractory Multiple Myeloma
September 21, 2023 updated by: Weijun Fu
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of BCMA-targeted LCAR-BCDR Cells Product in Patients With Relapsed/Refractory Multiple Myeloma
This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCDR cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China
- Not yet recruiting
- Shanghai Changzheng Hospital
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Contact:
- Weijun Fu, PhD
- Phone Number: 13816052522
- Email: fuweijun2010@163.com
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Shanghai, China
- Recruiting
- Shanghai Fourth People's Hospital Affiliated to Tongji University
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Contact:
- Weijun Fu
- Phone Number: 13816052522
- Email: fuweijun2010@163.com
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Tianjin, China
- Recruiting
- Institute of Hematology & Blood Diseases Hospital
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Contact:
- Gang An, PhD
- Phone Number: 13502181109
- Email: angang@ihcams.ac.cn
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Wenzhou, China
- Recruiting
- The First Affiliated Hospital of Wenzhou Medical University
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Contact:
- Songfu Jiang
- Phone Number: 15305770033
- Email: Jiangsongfu@189.cn
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-
Beijing
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Beijing, Beijing, China
- Recruiting
- Beijing GoBroad Boren Hospital
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Contact:
- Kai Hu
- Phone Number: 15010390336
- Email: xiaohu7079@sina.com
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-
Zhejiang
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Hangzhou, Zhejiang, China
- Recruiting
- Zhejiang Provincial People's Hospital
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Contact:
- Jianping Lan
- Phone Number: 13858039689
- Email: lanjp@163.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
- 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;
Exclusion Criteria:
- 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.
- Diagnosed or pretreated for an invasive malignancy other than multiple myeloma.
- Prior anti-tumor treatment (before pretreatment) with insufficient washout period.
- Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma.
- 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.
- Serious underlying medical conditions
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LCAR-BCDR cells product
Each subject will receive LCAR-BCDR cells
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Before treatment with LCAR-BCDR cells, subjects will receive a conditioning regimen
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Time Frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
|
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.
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Minimum 2 years after LCAR-BCDR infusion (Day 1)
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Recommended Phase 2 dose (RP2D) finding
Time Frame: 30 days after LCAR-BCDR infusion (Day 1)
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RP2D established through ATD+BOIN design
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30 days after LCAR-BCDR infusion (Day 1)
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CAR positive T cells in peripheral blood and bone marrow
Time Frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
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CAR positive T cells in peripheral blood and bone marrow after LCAR-BCDR infusion
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Minimum 2 years after LCAR-BCDR infusion (Day 1)
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CAR transgene levels in peripheral blood and bone marrow
Time Frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
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CAR transgene levels in peripheral blood and bone marrow after LCAR-BCDR infusion
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Minimum 2 years after LCAR-BCDR infusion (Day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR)
Time Frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
|
The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria.
|
Minimum 2 years after LCAR-BCDR infusion (Day 1)
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Progression-free survival (PFS)
Time Frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
|
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-BCDR to the first documented disease progression (according to IMWG criteria) or death (due to any cause), whichever occurs first
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Minimum 2 years after LCAR-BCDR infusion (Day 1)
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Overall Survival (OS)
Time Frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
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Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-AIO to death of the subject
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Minimum 2 years after LCAR-BCDR infusion (Day 1)
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Incidence of anti-LCAR-BCDR antibody
Time Frame: Minimum 2 years after LCAR-BCDR infusion (Day 1)
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Venous blood samples will be collected to measure LCAR-BCDR positive cell concentrations and the transgenic level of LCAR-BCDR, at the time points when anti-LCAR-BCDR antibody serum samples are evaluated
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Minimum 2 years after LCAR-BCDR infusion (Day 1)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
May 12, 2022
First Submitted That Met QC Criteria
May 12, 2022
First Posted (Actual)
May 17, 2022
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- BM2L202103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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