Combination of humanized anti-CD19 CAR-T and anti-BCMA CAR-T versus anti-BCMA CAR-T alone for relapsed or refractory multiple myeloma:a multicenter, open-label, randomized controlled trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026219

Enrollment

Unknown

Registered

2019-09-27

Start date

2019-10-01

Completion date

Unknown

Last updated

2019-09-30

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

Conditions

Multipal Myeloma

Interventions

A:anti-BCMA CAR-T

B:anti-CD19 CAR-T and anti-BCMA CAR-T

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female participants aged >= 18 and 12 weeks. 3. Participants must have a confirmed diagnosis of multiple myeloma. 4. Refractory multiple myeloma patients. 5. Relapsed multiple myeloma patients. 6. ALT/AST = 50%). 9. No serious liver, kidney, heart and other diseases at the time of enrollment. 10. Relapse after auto- or allo- hematopoietic stem cell transplantation (HSCT). 11. Not eligible for HSCT or abandoned HSCT because physical condition is not allowed. 12. Voluntarily participated in the trial of CAR-T for the treatment of multiple myeloma. 13. Blood was collected intravenously and no other contraindications for aphresis. 14. Informed Consent/Assent: All subjects have the ability to understand and the willingness to sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, or female with a pregnancy plan within six months; 2. Infectious diseases (eg HIV, active tuberculosis, etc.); 3. Active hepatitis B or hepatitis C; 4. Evaluation screening showed that the transfected lymphocytes was less than 10% or proliferation< 5 times under the co-stimulation of CD3/CD28; 5. Abnormal vital signs and failure to cooperate with the examination; 6. Any mental or psychological illnesses that could, in the investigator's opinion, potentially interfere with the completion of treatment; 7. Highly allergic constitution or history of severe allergies, especially to IL-2; 8. Systemic or severe local infections require anti-infective treatment; 9. Evidence of current uncontrolled dysfunction of heart, lung, brain, kidney and other important organs; 10. Active and severe auto-immune disease; 11. Other conditions that are not eligible for the trial in the judgment of the principal investigator.

Design outcomes

Primary

Measure	Time frame
PFS;OS;ORR;RFS;	—

Secondary

Measure	Time frame
safety;	—

Countries

china

Contacts

Public ContactZhenyu Li

The Affiliated Hospital of Xuzhou Medical University

lizhenyumd@163.com+86 18052269668

Outcome results

None listed

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