A Study of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

NCT04670055 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: hBCMA-ZhejiangU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Trial for the safety and efficacy of humanized BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma

Conditions

Relapse Multiple Myeloma; Refractory Multiple Myeloma

Keywords

multiple myeloma; CAR T-cell therapy; BCMA

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

Study Arms (1)

Administration of BCMA Targeted CAR T-cells

EXPERIMENTAL

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Drug: BCMA Targeted CAR T-cells

Interventions

BCMA Targeted CAR T-cells DRUG

Each subject receive BCMA Targeted CAR T-cells by intravenous infusion

Also known as: BCMA Targeted CAR T-cells injection

Administration of BCMA Targeted CAR T-cells

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;
• Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
• Anticipated survival time more than 12 weeks;
• Male or female aged 30-75 years;
• 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;
• 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.

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital, Medical College, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

• 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: 39501801 DERIVED

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

He Huang, PhD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

86-15957162012; huyongxian2000@aliyun.com

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: December 9, 2020
• First Posted: December 17, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)