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An open, single-center, single-arm clinical study of t anti-BCMA CAR-T and anti-CD138 CAR-T therapy for relapsed and refractory multiple myeloma

An open, single-center, single-arm clinical study of t anti-BCMA CAR-T and anti-CD138 CAR-T therapy for relapsed and refractory multiple myeloma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033194
Enrollment
Unknown
Registered
2020-05-23
Start date
2020-05-25
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

Multiple myeloma

Interventions

Sponsors

the Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients diagnosed with multiple myeloma have no effective treatment options (such as autologous or allogeneic stem cell transplantation) and have limited prognosis with existing therapies ( 12 weeks; 3. Multiple myeloma diagnosed by physical examination, pathological examination, laboratory examination and imaging; 4. Patients with multiple myeloma chemotherapy failure; 5. Patients with multiple myeloma recurrence; 6. ALT, AST 50%; 9. Failure of autologous stem cell and allogeneic stem cell transplantation; 10. Not suitable for stem cell transplantation conditions or for abandoning transplantation due to conditional restrictions; 11. Blood can be taken intravenously without other contraindications for leukapheresis; 12. Can understand and voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating women, or women with a pregnancy plan within six months; 2. infectious diseases (such as HIV, active tuberculosis, etc.); 3. Active hepatitis B or C infection; 4. Feasibility assessment screening demonstrates that transfection of targeted lymphocytes is < 10% or insufficiently amplified by CD3/CD28 co-stimulation (< 5 fold); 5. Vital signs are not normal and cannot be matched with the examiner; 6. Those who have mental or mental illnesses that cannot be combined with treatment and efficacy evaluation; 7. Highly allergic or have a history of severe allergies, especially those who are allergic to IL-2; 8. Systemic infections or localized serious infections require anti-infective treatment of subjects; 9. Combine dysfunction of important organs such as heart, lung, brain and kidney; 10. Subjects with severe autoimmune diseases; 11. The doctor believes that there are other reasons that cannot be included in the treatment.

Design outcomes

Primary

MeasureTime frame
ORR;

Countries

China

Contacts

Public ContactLi Zhenyu

The Affiliated Hospital of Xuzhou Medical University

lizhenyumd@163.com+86 051685806985

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026