Menu
Recruiting NCT04657861

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

Early Phase I Interventional Multiple Myeloma in Relapse Multiple Myeloma, Refractory

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APRIL CAR-T cells.
Who it may be relevant to
Registry conditions: Multiple Myeloma in Relapse, Multiple Myeloma, Refractory. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: Baseline up to 28 days after APRIL targeted CAR T-cells infusion]
  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Time Frame: Up to 2 years after APRIL targeted CAR T-cells infusion]
Secondary outcome measures (7)
  • Multiple Myeloma (MM), Overall response rate (ORR) [Time frame: 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]
  • MM, Event-free survival (EFS) [Time frame: Up to 2 years after APRIL CAR-T cells infusion]
  • Quality of life including sports activity [Time frame: 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]
  • Instrumental Activities of Daily Living (IADL) score [Time frame: 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]

Eligibility criteria

Inclusion criteria

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital，College of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT04657861 · APRIL-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗