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An open, single-center, single-arm clinical study of through lenalidomide combined with infusion of anti-BCMA CAR-T and anti-CD19 CAR-T therapy for relapsed and refractory multiple myeloma

An open, single-center, single-arm clinical study of through lenalidomide combined with infusion of anti-BCMA CAR-T and anti-CD19 CAR-T therapy for relapsed and refractory multiple myeloma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024035
Enrollment
Unknown
Registered
2019-06-23
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-06-26

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

Conditions

multiple myeloma

Interventions

1:lenalidomide lenalidomide combined with infusion of anti-BCMA CAR-T and anti-CD19 CAR-T therapy

Sponsors

the Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

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

Department of Hematology, the Affiliated Hospital of Xuzhou Medical University

lizhenyume@163.com+86 15950688971

Outcome results

None listed

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