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

• Sponsor: Zhejiang University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04670055
• Collaborator: Yake Biotechnology Ltd. (Industry)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Relapse Multiple Myeloma; Refractory Multiple Myeloma	Drug: BCMA Targeted CAR T-cells	Early Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Trial for the Safety and Efficacy of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
• Anticipated Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Administration of 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.	Drug: BCMA Targeted CAR T-cells; Each subject receive BCMA Targeted CAR T-cells by intravenous infusion; Other Names: BCMA Targeted CAR T-cells injection

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. Overall response rate (ORR) [At Day 28]

   Assessment of ORR at Day 28

2. Overall survival (OS) [At Month 6, 12, 24]

   Assessment of OS at Month 6, 12, 24

3. 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

4. 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

5. 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

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

2. Patients with BCMA positive relapsed/refractory MM;

3. Relapsed after hematopoietic stem cell transplantation;

4. Cases with recurrent positive minimal residual disease;

5. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.

6. Anticipated survival time more than 12 weeks;

7. Male or female aged 30-75 years;

8. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital, Medical College, Zhejiang University	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

• Zhejiang University
• Yake Biotechnology Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: He Huang, Clinical Professor, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04670055
• Other Study ID Numbers: hBCMA-ZhejiangU
• First Posted: Dec 17, 2020
• Last Update Posted: Dec 17, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by He Huang, Clinical Professor, Zhejiang University: multiple myeloma; CAR T-cell therapy; BCMA
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Dec 17, 2020