Therapy relapse/ refractory mutiple myeloma with anti-CD138 and antiBCMA CAR-T cells

A clinic trial for treatment relapse/ refractory mutiple myeloma with anti-CD138 and antiBCMA CAR-T cells

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900023115

Enrollment

Unknown

Registered

2019-05-11

Start date

2019-08-01

Completion date

Unknown

Last updated

2019-05-13

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

Conditions

mutiple myeloma

Interventions

treatment group:anti-CD138 and antiBCMA CAR-T cells infusion

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Male or female surface antigens confirm multiple myeloma and there is no available treatment (including autologous or allogeneic stem cell transplantation). 2) Four or more early combination therapies failed to achieve complete remission. 3) CR2 or CR3 type MM; not eligible for allogeneic stem cell transplantation due to age, complications or lack of available donors. 4) less than a year between the latest chemotherapy and the disease progress. 5) Multiple bone marrow relapse after autologous or allogeneic stem cell transplantation in patients with muliple myeloma who have been treated for at least one relapse and refractory disease; patients who are not eligible for allogeneic stem cell transplantation criteria. 6) Residual diseases after primary treatment;It does not meet the treatment conditions of autologous hematopoietic stem cell transplantation. 7) Any MM patient who relapses after autologous hematopoietic stem cell transplantation. 8) Expected survival over 12 weeks 9) The function of important organs is basically normal:Cardiac function: Ejection fraction (> 50%) was indicated by echocardiography, and no abnormal ECG was observed; Renal function:serum creatinine < 2.0×ULN (normal upper limit); Liver function:ALT and AST < 3.0 *ULN (normal upper limit), total bilirubin and alkaline phosphatase < 2.0 *ULN (normal upper limit); 10) It has sufficient venous access and lymphocyte count (no less than 0.5 *109/L) for hemapheresis or intravenous blood collection, and no other contraindications for blood cell separation. 11) The patient or his legal representative signed the informed consent.

Exclusion criteria

Exclusion criteria: 1)Pregnant or lactating women. 2)Uncontrollable active infection 3)Use of systemic steroids; recent or current use of inhaled steroids is not excluded. 4)Previous CAR-T cell therapies have produced any uncontrolled disease. 5)HIV infection

Design outcomes

Primary

Measure	Time frame
complete remission rate;	—

Secondary

Measure	Time frame
2 year overall survival ;respone rate;PFS;overal suvival time ;	—

Countries

China

Contacts

Public ContactWu Bingyi

Shunde Hospital of Southern Medical University

wubingyi@aliyun.com+86 18680288775

Outcome results

None listed

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