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An open single center single arm clinical study of anti-BCMA CAR-T and anti-CD38 antibody sequential therapy for relapsed and refractory multiple myeloma

An open single center single arm clinical study of anti-BCMA CAR-T and anti-CD38 antibody sequential therapy for relapsed and refractory multiple myeloma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032918
Enrollment
Unknown
Registered
2020-05-15
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

multiple myeloma

Interventions

experimental group:anti-BCMA CAR-T cells and anti-CD38 antibody

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-80 years; 2. Histologically/Immunohistochemistry confirmed CD38-positive and BCMA-positive multiple myeloma; 3. Patients who failed to receive chemotherapy for multiple myeloma or Patients with multiple myeloma recurrence; 4. ECOG performance status 0 to 2; 5. Patients without serious liver, kidney, heart and other diseases; 6. Patients who failed to receive autologous stem cells or allogeneic stem cells transplantation or 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; 7. Patients who can understand and voluntarily sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Life expectancy < 3 months; 2. Pregnancy or lactation; 3. Patients with active hepatitis B or C infection; 4. Patients with mental or psychological diseases who can not cooperate with treatment and efficacy evaluation; 5. History of anaphylactic reaction to humanized or human antibodies or a Grade 3 or 4 administration reaction during a daratumumab administration; 6. The doctor thinks there are patients who cannot be included in the treatment for other reasons.

Design outcomes

Primary

MeasureTime frame
safety;Overall remission rate;Progression Free Survival;Extramedullary infiltration;

Countries

China

Contacts

Public ContactMingfeng Zhao

Tianjin First Central Hospital

mingfengzhao@sina.com+86 13752640369

Outcome results

None listed

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