- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04727008
CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma
December 5, 2023 updated by: Ting Niu, Sichuan University
Phase I Study of A CXCR4 Modified BCMA CAR-T in Patients With Refractory and/or Relapsed Multiple Myeloma
Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies.
B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells.
This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts.
The efficacy of CXCR4 modified BCMA CAR T will also be investigated.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
12
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 Contact
- Name: DAN LI, Ph.D
- Phone Number: +86(028)85423525
- Email: lidan@wchscu.cn
Study Contact Backup
- Name: FUCHUN GUO, MD
- Phone Number: +86(028)85423525
- Email: FCguo0797@wchscu.cn
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- West China Hospital, Sichuan University
-
Contact:
- Dan Li
- Phone Number: 02885422707
- Email: lidan@wchscu.cn
-
-
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female, 18 to 75 years old.
- The expected survival ≥ 12 week
- ECOG ≤ 2
- Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse
- The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease
- Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection
- Patients can take effective contraceptive measures during the trial period and 1 year after the infusion
- Voluntary informed consent is given, agree to follow the trial treatment and visit plan
Exclusion Criteria:
- Patients with other uncontrollable cancer
- Active hepatitis B, hepatitis C, or HIV infection
- Other uncontrolled active disease
- Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases
- Patients with uncontrollable hypertension(≥ grade II)
- Patients with history of uncontrollable mental illness
- Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded)
- Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment;
- Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period;
- Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment;
- Patients had other conditions that were not appropriate for the study determined by the researchers.
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: CXCR4 modified anti-BCMA CAR T cell therapy
CAR T cell therapy
|
intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose limiting toxicities (DLT)
Time Frame: 2 years
|
Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration
|
2 years
|
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR (overall response rate)
Time Frame: 3 months,6 months
|
Proportion of subjects with the best overall response (BOR)
|
3 months,6 months
|
CRR (complete response rate)
Time Frame: 3 months
|
Proportion of subjects with the BOR of sCR+CR at Month 3
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 21, 2022
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
November 30, 2020
First Submitted That Met QC Criteria
January 25, 2021
First Posted (Actual)
January 27, 2021
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
December 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
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Idecabtagene vicleucel
Other Study ID Numbers
- MCART-001
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.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
-
National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on CXCR4 modified anti-BCMA CAR T cells
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Southwest Hospital, ChinaUnknownLymphoma | Leukemia | Multiple MyelomaChina
-
Zhejiang UniversityYake Biotechnology Ltd.RecruitingMultiple Myeloma | New Diagnosis TumorChina
-
University College, LondonEnrolling by invitationMultiple MyelomaUnited Kingdom
-
Zhejiang UniversityYake Biotechnology Ltd.Not yet recruitingRefractory Multiple Myeloma | Relapse Multiple MyelomaChina
-
Zhejiang UniversityYake Biotechnology Ltd.RecruitingRefractory Multiple Myeloma | Relapse Multiple MyelomaChina
-
Zhejiang UniversityYake Biotechnology Ltd.RecruitingVasculitis | Amyloidosis | Autoimmune Hemolytic Anemia | POEMS SyndromeChina
-
Allife Medical Science and Technology Co., Ltd.UnknownRelapsed and Refractory Multiple Myeloma
-
Chongqing Precision Biotech Co., LtdRecruitingMultiple Myeloma | Multiple Myeloma in Relapse | Neoplasm, Plasma CellChina
-
Shenzhen University General HospitalRecruitingMultiple Myeloma | Refractory Multiple Myeloma | Relapse Multiple MyelomaChina
-
Chongqing Precision Biotech Co., LtdRecruitingMultiple Myeloma | Multiple Myeloma in Relapse | Neoplasm, Plasma CellChina