🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07519187
Recruiting Phase EARLY_PHASE1

CAR 70-BCMA CAR-T Cells for the Treatment of Relapsed or Refractory Plasma Cell Neoplasms

NCT07519187 · tracked via the Priya Life Science China tracker
Sponsor
The General Hospital of Western Theater Command
Phase
Phase EARLY_PHASE1
Started
2026-04-23
Last updated
2026-06-09

Condition(s) studied

Relapsed or Refractory Plasma Cell Neoplasms

Investigational drug(s) / intervention(s)

CAR 70-BCMA CAR-T

CAR 70-BCMA CAR-T: Each subject will receive a single infusion of BCMA-CD70-CAR-T cells. A classic "3+3" dose escalation design will be employed.

Study summary

This is a single arm study to evaluate the safety and efficacy of CAR70-BCMA dual-target CAR-T cell therapy for relapsed and refractory plasma cell neoplasms.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. The subject or their legally authorized representative has provided written informed consent and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures 2. Diagnosis of relapsed or refractory plasma cell neoplasms, defined as follows: * Clonal plasma cells positive for BCMA and/or CD70 expression as determined by flow cytometry or immunohistochemistry * Patients with multiple myeloma, plasmacytoma, or plasma cell leukemia who have received at least three prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody, and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR * Patients with systemic light chain amyloidosis who have received at least two prior lines of therapy, including an anti-CD38 monoclonal antibody and either a proteasome inhibitor (PI) or an immunomodulatory agent (IMiD), and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR 3. Aged 18 to 75 years (inclusive), male or female 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 5. Life expectancy greater than 3 months from the date of informed consent 6. Hemoglobin (HGB) ≥ 60 g/L (transfusion permitted) 7. Adequate hepatic, renal, cardiac, and pulmonary function meeting the following criteria: * Creatinine ≤ 2 × upper limit of normal (ULN) * Left ventricular ejection fraction (LVEF) ≥ 50% * Oxygen saturation \> 90% * Total bilirubin ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN 8. The subject agrees to use contraceptive measures from the time of signing the informed consent form until 1 year after CAR-T cell infusion Exclusion Criteria: * Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) \< 50% * History of severe pulmonary function impairment * Concurrent progressive malignancy * Concurrent severe infection that cannot be adequately controlled * Concurrent severe autoimmune disease or congenital immunodeficiency * Active hepatitis, defined as hepatitis B virus deoxyribonucleic acid (HBV-DNA) or hepatitis C virus ribonucleic acid (HCV-RNA) above the lower limit of detection * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection * History of severe allergic reaction to biological products (including antibiotics) * Patients who have undergone allogeneic hematopoietic stem cell transplantation and still have acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents * Presence of any other serious physical or mental illness, or laboratory abnormality that may increase the risk of study participation, interfere with the interpretation of study results, or render the patient unsuitable for study enrollment in the opinion of the investigator * Female patients of childbearing potential who are pregnant or breastfeeding

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
General Hospital of Western Theater Command of PLA Chengdu Chengdu Recruiting

More The General Hospital of Western Theater Command trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07519187 on ClinicalTrials.gov ↗ ← All trials in China