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The clinical study of anti-?-CAR-T in the treatment of relapsed and refractory multiple myeloma

The clinical study of anti-?-CAR-T in the treatment of relapsed and refractory multiple myeloma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048887
Enrollment
Unknown
Registered
2021-07-19
Start date
2021-07-30
Completion date
Unknown
Last updated
2022-03-28

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

Conditions

GPRC5D positive relapsed and refractory multiple myeloma

Interventions

experimental group:anti-?-CAR-T

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with multiple myeloma have no effective treatment options (such as autologous or allogeneic stem cell transplantation) and have limited prognosis with existing therapies ( 12 weeks; 4. Multiple myeloma diagnosed by physical examination, pathological examination, laboratory examination and imaging; 5. Patients with multiple myeloma chemotherapy failure; 6. Patients with multiple myeloma recurrence; 7. ALT, AST 50%; 10. Failure of autologous stem cell and allogeneic stem cell transplantation; 11. Not suitable for stem cell transplantation conditions or for abandoning transplantation due to conditional restrictions; 12. Blood can be taken intravenously without other contraindications for leukapheresis; 13. Can understand and voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, or women with a pregnancy plan within six months; 2. Infectious diseases (such as HIV, active tuberculosis, etc); 3. Active hepatitis B or C infection; 4. Feasibility assessment screening demonstrates that transfection of targeted lymphocytes is < 10% or insufficiently amplified by CD3/CD28 co-stimulation (< 5 fold); 5. Vital signs are not normal and cannot be matched with the examiner; 6. Those who have mental or mental illnesses that cannot be combined with treatment and efficacy evaluation; 7. Highly allergic or have a history of severe allergies, especially those who are allergic to IL-2; 8. Systemic infections or localized serious infections require anti-infective treatment of subjects; 9. Combine dysfunction of important organs such as heart, lung, brain and kidney; 10. Subjects with severe autoimmune diseases; 11. The doctor believes that there are other reasons that cannot be included in the treatment.

Design outcomes

Primary

MeasureTime frame
overall response rate;

Countries

China

Contacts

Public ContactXu Kailin

Affiliated Hospital of Xuzhou Medical University

lihmd@163.com+86 051685806985

Outcome results

None listed

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