CAR70-BCMA CAR-T Cells for Relapsed or Refractory Plasma Cell Neoplasms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase, single-arm trial investigates the safety and potential effectiveness of CAR70-BCMA dual-target CAR-T cells in patients with relapsed or refractory plasma cell neoplasms, including multiple myeloma, plasmacytoma, plasma cell leukemia, or systemic light chain amyloidosis. Eligible participants must have BCMA and/or CD70 expression and have exhausted at least three prior lines of therapy (or at least two lines for AL amyloidosis), with prior regimens including a PI, an IMiD, and an anti-CD38 antibody. CAR70-BCMA CAR-T cells are administered to assess safety signals and preliminary antitumor activity, with monitoring for typical CAR-T-related adverse events and responses. The study is conducted at a single center under the lead sponsor The General Hospital of Western Theater Command in Chengdu, China.

Why it matters

Who can join: the full rules

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

Where it's running

• General Hospital of Western Theater Command of PLA
  Chengdu, Chengdu, China Recruiting

Study contacts

• Study coordinator: Hai Yi
• Email: yihaimail@163.com
• Phone: 13699418229

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.