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An open single center single arm clinical study of through infusion of anti-BCMA CAR-T and anti-CD38 CAR-T therapy for relapsed and refractory multiply myeloma

An open single center single arm clinical study of through infusion of anti-BCMA CAR-T and anti-CD38 CAR-T therapy for relapsed and refractory multiply myeloma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032501
Enrollment
Unknown
Registered
2020-04-30
Start date
2020-04-28
Completion date
Unknown
Last updated
2020-05-04

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

Conditions

Multiple myeloma

Interventions

1:CAR-T cell infusion

Sponsors

Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70 years; 2. Patients whose estimated survival time is more than 12 weeks; 3. Patients diagnosed as multiple myeloma by physical examination, pathological examination, laboratory examination and imaging; 4. Patients who failed to receive chemotherapy for multiple myeloma; 5. Patients with multiple myeloma recurrence; 6. Alt, AST 50%; 8. Patients without serious liver, kidney, heart and other diseases; 9. Patients who failed to receive transplantation of autologous stem cells or allogeneic stem cells; 10. Patients who are not suitable for the conditions of stem cell transplantation or who give up the transplantation due to the limitations of the conditions; 11. Patients who can take blood from vein without other contraindications of leukocyte collection; 12. Patients who can understand and voluntarily sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, or women who have pregnancy plans within half a year; 2. Patients with infectious diseases (such as HIV, active tuberculosis, etc.); 3. Patients with active hepatitis B or C infection; 4. Feasibility evaluation and screening showed that the target lymphocyte transfection was less than 10% or the amplification was less than 5 times under the stimulation of CD3 / CD28; 5. The patients with abnormal vital signs and unable to cooperate with the examination; 6. Patients with mental or psychological diseases who can not cooperate with treatment and efficacy evaluation; 7. Patients with high allergic constitution or severe allergic history, especially those allergic to IL-2; 8. Patients who need anti infection treatment for systemic infection or local severe infection; 9. Patients with serious autoimmune diseases; 10. The doctor thinks there are patients who cannot be included in the treatment for other reasons.

Design outcomes

Primary

MeasureTime frame
Overoll response rate;Progression-free survival;Overoll survival;Safety;

Countries

China

Contacts

Public ContactKailin Xu

The Affiliated Hospital of Xuzhou Medical University

lihmd@163.com+86 516-85806982

Outcome results

None listed

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