A Study of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Clinical Trial for the Safety and Efficacy of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
1 other identifier
interventional
100
1 country
1
Brief Summary
Clinical Trial for the safety and efficacy of BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2022
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2022
CompletedStudy Start
First participant enrolled
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2025
CompletedJune 24, 2022
June 1, 2022
3 years
June 18, 2022
June 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Baseline up to 28 days after BCMA targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Up to 2 years after BCMA targeted CAR T-cells infusion
Secondary Outcomes (6)
Overall response rate (ORR)
At Day 28
Overall survival (OS)
At Month 6, 12, 24
Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)
At Baseline, Month 1, 3, 6, 9 and 12
Instrumental Activities of Daily Living (IADL) score
At Baseline, Month 1, 3, 6, 9 and 12
Activities of Daily Living (ADL) score
At Baseline, Month 1, 3, 6, 9 and 12
- +1 more secondary outcomes
Study Arms (1)
Administration of BCMA Targeted CAR T-cells
EXPERIMENTALDose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
Interventions
Each subject receive BCMA Targeted CAR T-cells by intravenous infusion
Eligibility Criteria
You may qualify if:
- \. Histologically confirmed diagnosis of multiple myeloma (MM):
- Patients with BCMA positive relapsed/refractory MM;
- Relapsed after hematopoietic stem cell transplantation;
- Cases with recurrent positive minimal residual disease;
- Repeated MRD(+) refractory resistant cases
- Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
- \. Anticipated survival time more than 12 weeks; 3. Transplant patients, regardless of their previous treatment, are eligible after relapse; 4. Those who voluntarily participated in this trial and provided informed consent.
You may not qualify if:
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- With a graft-versus-host response, immunosuppressants are required;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
- Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
- Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
- Other uncontrolled diseases that were not suitable for this trial;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhejiang Universitylead
- Yake Biotechnology Ltd.collaborator
Study Sites (1)
The First Affiliated Hospital, Medical College, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Related Publications (2)
Chen R, Jin C, Liu K, Zhao M, Yang T, Zhang M, Xiao P, Feng J, Hong R, Fu S, Cui J, Huang S, Wei G, Huang H, Hu Y. Predictive value of pre-treatment circulating tumor DNA genomic landscape in patients with relapsed/refractory multiple myeloma undergoing anti-BCMA CAR-T therapy: Insights from tumor cells and T cells. Chin Med J (Engl). 2024 Nov 6;138(19):2481-90. doi: 10.1097/CM9.0000000000003306. Online ahead of print.
PMID: 39501801DERIVEDZhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.
PMID: 37192741DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 18, 2022
First Posted
June 24, 2022
Study Start
June 20, 2022
Primary Completion
June 20, 2025
Study Completion
June 20, 2025
Last Updated
June 24, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share