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

Early Phase 1

Recruiting

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

• Registration Number: NCT05430945
• Lead Sponsor: Zhejiang University

Brief Summary

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

Detailed Description

In this study, 100 patients with relapsed refractory multiple myeloma were proposed to undergo BCMA CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of BCMA CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on BCMA CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-18
• Study First Submitted QC: 2022-06-18
• Last Update Submitted: 2022-06-18
• Study Start: 2022-06-20
• Study First Posted: 2022-06-24
• Last Update Posted: 2022-06-24
• Primary Completion: 2025-06-20
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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. Repeated MRD(+) refractory resistant cases

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

     2. 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.

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. With a graft-versus-host response, immunosuppressants are required;
  5. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  6. Active infection of hepatitis B virus or hepatitis C virus;
  7. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
  8. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
  9. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
  10. Other uncontrolled diseases that were not suitable for this trial;
  11. Patients with HIV infection;
  12. 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
Incidence of treatment-emergent adverse events (TEAEs)	Up to 2 years after BCMA targeted CAR T-cells infusion	Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
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

Secondary Outcome Measures

Name	Time	Method
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
Overall response rate (ORR)	At Day 28	Assessment of ORR at Day 28
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
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
Overall survival (OS)	At Month 6, 12, 24	Assessment of OS at Month 6, 12, 24
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

Trial Locations

Locations (1)

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