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Humanized BCMA CAR-T cell therapy for relapse or refractory multiple myeloma

Humanized BCMA chimeric antigen receptor T cells (CART) therapy for relapse or refractory multiple myeloma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033925
Enrollment
Unknown
Registered
2020-06-17
Start date
2020-06-16
Completion date
Unknown
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapse or refractory multiple myeloma

Interventions

Group 1:Humanized BCMA CAR-T treatment
Group 2:Humanized BCMA CAR-T treatment for murine BCMA CAR-T treatment failure

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients or legal guardians sign informed consent; 2. Male or female patients aged 18-85 (including 18 and 85 years); 3. The patients who were diagnosed as multiple myeloma by cell morphology and flow cytometry were found to have poor curative effect after receiving the standard treatment plan, and were diagnosed as relapsed refractory multiple myeloma. 4. Patients with measurable or evaluable lesions; 5. The function of main tissues and organs of the patient is good: (1) Liver function: ALT / AST = 95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >= 40%. 6. Patients whose peripheral superficial vein blood flow is unobstructed and can meet the needs of intravenous drip; 7. Patients with Karnofsky score >= 60.

Exclusion criteria

Exclusion criteria: 1. Women in pregnancy (positive urine / blood pregnancy test) or lactation; 2. Men or women who have pregnancy plans in the past year; 3. The patients can not guarantee to take effective contraceptive measures (condoms or contraceptives, etc.) within one year after entering the group; 4. Patients with uncontrollable infectious diseases within 4 weeks before enrollment; 5. HIV infected patients; 6. Patients with primary tumors other than B-cell lymphoma diagnosed by pathology; 7. Patients with serious autoimmune diseases or immunodeficiency diseases; 8. Patients with allergic constitution are allergic to macromolecular biological drugs such as antibodies or cytokines; 9. Patients who participated in other clinical trials within 6 weeks before admission; 10. Patients who systematically used hormone within 4 weeks before admission (except those who used inhaled hormone); 11. Patients with mental illness; 12. Patients with drug abuse / addiction; 13. According to the judgment of the researcher, other patients are not suitable for the group.

Design outcomes

Primary

MeasureTime frame
remission rate;

Secondary

MeasureTime frame
Progression-free survival;Overall survival;

Countries

China

Contacts

Public ContactDeng Qi

Tianjin First Central Hospital

kachydeng@hotmail.com+86 13612055872

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 27, 2026