CS1 Targeted CAR T-cells: Each subject receive CS1 Targeted CAR T-cells by intravenous infusion
Study summary
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
Sex
ALL
Min age
30 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Histologically confirmed diagnosis of CS1+ multiple myeloma (MM)：
1. Patients with MM relapsed after BCMA CAR-T therapy;Or MM with positive CS1 expression and negative BCMA 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. Anticipated survival time more than 12 weeks;
3. Male or female aged 30-75 years;
4. Those who voluntarily participated in this trial and provided 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 hemorrhagicdiseases;
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 infectionand 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 inhaled 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.
Primary outcome measure(s)
Dose-limiting toxicity (DLT) — Baseline up to 28 days after CS1 targeted CAR T-cells infusion Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs) — Up to 2 years after CS1 targeted CAR T-cells infusion Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital，College of Medicine, Zhejiang University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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