BCMA-CAR-T\CD138-CAR-T cell sequential therapy for relapse refractory Multiple Myeloma clinical study

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900023624

Enrollment

Unknown

Registered

2019-06-04

Start date

2019-06-01

Completion date

Unknown

Last updated

2019-06-11

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

Conditions

relapse refractory Multiple Myeloma

Interventions

Case series:BCMA-CAR-T\CD138-CAR-T cell therapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 18 to 70 years; 2. Diagnosis of BCMA+\CD138+MM by pathological and histological examination; 3. ECOG score = 2 points,Estimated survival time >3 months; 4. BCMA+\CD138+ Multiple Myeloma patients received>1 Radiotherapy and chemotherapy but failed or recurred; 5. The main organs of the patients are great: (1) Liver function :ALT/AST40mL/min; (3) Lung function: blood oxygen saturation >95%; (4) Cardiac function: left ventricular ejection fraction (LVEF)>50%; 6. Platelets > 40 * 10^9/L; 7. Patients did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) or other anticancer treatment within 2-4 weeks before enrollment,and the previous treatment-related toxicity was restored to <1 grade(except alopecia, peripheral neuritis and other low-level toxicity ); 8. Thevenous channel of patient is unobstructed and can meet the needs of intravenous infusion; The patient signed the informed consent form, and follow the treatment and visit plan.

Exclusion criteria

Exclusion criteria: 1. Severe autoimmune disease or immunodeficiency disease; 2. Uncontrollable infection during the first 4 weeks of study; 3. Active hepatitis B HBV DNA>1000copy/mL or C virus (anti-HCV positive, HCV RNA positive); HIV positive, syphilis; 4. Those who have participated in other clinical studies in the past 6 weeks; 5. Patiens with mental illness; 6. The patient has drug abuse/addiction or whose medical, psychological or social conditions may interfere with research or influence the evaluation of research results; 7. Pregnant(Urine/blood pregnancy tests are positive) or lactating women;Men or women planning to become pregnant within the last year;Patients do not guarantee effective contraception during the study period; 8. Other ineligible patients are determined by the researchers.

Design outcomes

Primary

Measure	Time frame
PET-CT;	—

Countries

China

Contacts

Public ContactKai Sun

He'nan Provincial People's Hospital

sunkai@cellscience.org+86 18237110038

Outcome results

None listed

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