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

ConditionsRelapse Multiple MyelomaRefractory Multiple Myeloma
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age30-75
SponsorZhejiang University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with BCMA positive relapsed/refractory MM;

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.

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

  • BCMA Targeted CAR T-cells

    Drug

    Each subject receive BCMA Targeted CAR T-cells by intravenous infusion

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Administration of BCMA Targeted 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 BCMA targeted CAR T-cells infusion
2

Incidence of treatment-emergent adverse events (TEAEs)

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

Time frame
Up to 2 years after BCMA targeted CAR T-cells infusion

Secondary outcomes

1

Overall response rate (ORR)

Assessment of ORR at Day 28

Time frame
At Day 28
2

Overall survival (OS)

Assessment of OS at Month 6, 12, 24

Time frame
At Month 6, 12, 24
3

Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)

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
4

Instrumental Activities of Daily Living (IADL) score

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

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

This trial is not recruiting at the moment. You can still explore other options: