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

ConditionsMultiple Myeloma in RelapseMultiple Myeloma, Refractory
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • APRIL CAR-T cells

    Drug

    Each subject receive APRIL CAR T-cells by intravenous infusion

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Administration of APRIL CAR T-cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Time frame
Baseline up to 28 days after APRIL targeted CAR T-cells infusion
2

Incidence of treatment-emergent adverse events (TEAEs)

Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Time frame
Time Frame: Up to 2 years after APRIL targeted CAR T-cells infusion

Secondary outcomes

1

Multiple Myeloma (MM), Overall response rate (ORR)

Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 1, 3, 6, 12, 18 and 24

Time frame
At Month 1, 3, 6, 12, 18 and 24
2

MM, Overall survival (OS)

From the first infusion of APRIL CAR-T cells to death or the last visit

Time frame
Up to 2 years after APRIL CAR-T cells infusion
3

MM, Event-free survival (EFS)

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

Time frame
Up to 2 years after APRIL CAR-T cells infusion
4

Quality of life including sports activity

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

Time frame
At Baseline, Month 1, 3, 6, 9 and 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Yake Biotechnology Ltd.

Collaborator

Source ClinicalTrials.gov
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