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A Study of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy

ConditionRelapse 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 CS1-targeted CAR-T Cells therapy for relapsed multiple myeloma after BCMA CAR-T cells therapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed diagnosis of CS1+ multiple myeloma (MM)：

Patients with MM relapsed after BCMA CAR-T therapy;Or MM with positive CS1 expression and negative BCMA 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 hemorrhagicdiseases;

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 infectionand bacterial pharyngitis);

Trial design

Design model

Single group

Treatments tested in this trial

  • CS1 Targeted CAR T-cells

    Drug

    Each subject receive CS1 Targeted CAR T-cells by intravenous infusion

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Administration of CS1 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 CS1 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 CS1 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

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: