APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma

Overview

A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma

Full Title of Study: “Clinical Trial for the Safety and Efficacy of APRIL CAR-T Cells Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 15, 2024

Detailed Description

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory BCMA/TACI positive relapsed and/or refractory multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Interventions

  • Drug: APRIL CAR-T cells
    • Each subject receive APRIL CAR T-cells by intravenous infusion

Arms, Groups and Cohorts

  • Experimental: Administration of APRIL CAR T-cells
    • Each subject receive APRIL CAR T-cells by intravenous infusion

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Multiple Myeloma (MM), Overall response rate (ORR)
    • Time Frame: At Month 1, 3, 6, 12, 18 and 24
    • Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 1, 3, 6, 12, 18 and 24
  • MM, Overall survival (OS)
    • Time Frame: Up to 2 years after APRIL CAR-T cells infusion
    • From the first infusion of APRIL CAR-T cells to death or the last visit
  • MM, Event-free survival (EFS)
    • Time Frame: Up to 2 years after APRIL CAR-T cells infusion
    • From the first infusion of APRIL CAR-T cells to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit
  • Quality of life
    • Time Frame: 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
  • Activities of Daily Living (ADL) score
    • Time Frame: 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
  • Instrumental Activities of Daily Living (IADL) score
    • Time Frame: 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
  • Hospital Anxiety and Depression Scale (HADS) score
    • Time Frame: At Baseline, Month 1, 3, 6, 9 and 12
    • Assessment using Hospital Anxiety and Depression Scale (HADS) [max score: 42, min score: 0, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12

Participating in This Clinical Trial

Inclusion Criteria

1. Histologically confirmed diagnosis of BCMA/TACI+ multiple myeloma (MM): 1. Patients with MM relapsed after BCMA CAR-T therapy; Or MM with positive BCMA/TACI expression; 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. Male or female aged 18-75 years; 3. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; 4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; 6. Estimated survival time ≥ 3 months; 7. ECOG performance status 0 to 2; 8. Patients or their legal guardians volunteer to participate in the studyand sign the 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhejiang University
  • Collaborator
    • Yake Biotechnology Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: He Huang, Clinical Professor – Zhejiang University
  • Overall Contact(s)
    • He Huang, PhD, 86-13605714822, hehuangyu@126.com

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