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

Early Phase 1

Not yet recruiting

• Conditions: Relapse Multiple Myeloma; Refractory Multiple Myeloma
• Interventions: Drug: BCMA Targeted CAR T-cells

• Registration Number: NCT04670055
• Lead Sponsor: Zhejiang University

Brief Summary

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

Detailed Description

This is a single arm, open-label, single-center study. This study is indicated for relapsed BCMA+ multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 50 patients will be enrolled for this trial. Primary objective is to explore the safety, main consideration is dose-related safety.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Last Update Submitted: 2020-12-09
• Study First Posted: 2020-12-17
• Last Update Posted: 2020-12-17
• Study Start: 2021-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Histologically confirmed diagnosis of multiple myeloma (MM):

   1. Patients with BCMA positive relapsed/refractory MM;
   2. Relapsed after hematopoietic stem cell transplantation;
   3. Cases with recurrent positive minimal residual disease;
   4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.

2. Anticipated survival time more than 12 weeks;

3. Male or female aged 30-75 years;

4. Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria

Subjects with any of the following exclusion criteria were not eligible for this trial:

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
8. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of BCMA Targeted CAR T-cells	BCMA Targeted CAR T-cells	Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT)	Baseline up to 28 days after BCMA targeted CAR T-cells infusion	Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)	Up to 2 years after BCMA targeted CAR T-cells infusion	Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	At Day 28	Assessment of ORR at Day 28
Overall survival (OS)	At Month 6, 12, 24	Assessment of OS at Month 6, 12, 24
Hospital Anxiety and Depression Scale (HADS) score	At Baseline, Month 1, 3, 6, 9 and 12	Assessment of Hospital Anxiety and Depression Scale (HADS) score at Baseline, Month 1, 3, 6, 9 and 12
Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)	At Baseline, Month 1, 3, 6, 9 and 12	Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale \[For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome\] to measure Quality of life 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	Assessment of Instrumental Activities of Daily Living (IADL) scale \[max score: 56, min score: 14, higher scores mean a worse outcome\] at Baseline, Month 1, 3, 6, 9 and 12
Activities of Daily Living (ADL) score	At Baseline, Month 1, 3, 6, 9 and 12	Assessment using Activities of Daily Living (ADL) scale (Barthel Index) \[max score: 100, min score: 0, higher scores mean a better outcome\] at Baseline, Month 1, 3, 6, 9 and 12

Trial Locations

Locations (1)

The First Affiliated Hospital, Medical College, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China