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

Zhejiang University

Status and phase: Enrolling; Early Phase 1

Conditions: Relapse Multiple Myeloma; Refractory Multiple Myeloma

Treatments: Biological: BCMA Targeted CAR T-cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05430945

BCMA-ZhejiangU

Details and patient eligibility

About

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

Full description

In this study, 100 patients with relapsed refractory multiple myeloma were proposed to undergo BCMA CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of BCMA CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on BCMA CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 1. Histologically confirmed diagnosis of multiple myeloma (MM):

  2. Patients with BCMA positive relapsed/refractory MM;

  3. Relapsed after hematopoietic stem cell transplantation;

  4. Cases with recurrent positive minimal residual disease;

  5. Repeated MRD(+) refractory resistant cases

  6. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.

     2. Anticipated survival time more than 12 weeks; 3. Transplant patients, regardless of their previous treatment, are eligible after relapse; 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 hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  3. Pregnant (or lactating) women;
  4. With a graft-versus-host response, immunosuppressants are required;
  5. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  6. Active infection of hepatitis B virus or hepatitis C virus;
  7. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
  8. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
  9. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
  10. Other uncontrolled diseases that were not suitable for this trial;
  11. Patients with HIV infection;
  12. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Administration of BCMA Targeted CAR T-cells

Experimental group

Description:

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Treatment:

Biological: BCMA Targeted CAR T-cells