CAR 70-BCMA CAR-T Cells for the Treatment of Relapsed or Refractory Plasma Cell Neoplasms
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe General Hospital of Western Theater Command
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
CAR 70-BCMA CAR-T
GeneticEach subject will receive a single infusion of BCMA-CD70-CAR-T cells. A classic "3+3" dose escalation design will be employed.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: This is a single arm treatment of CAR 70-BCMA CAR-T cellExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the safety of CAR70-BCMA dual-target chimeric antigen receptor T-cell therapy in patients with relapsed or refractory plasma cell neoplasms expressing CD70 and/or BCMA based on the incidence of treatment-emergent adverse events (AEs).
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame
Up to 3 years2
To evaluate the safety of CAR70-BCMA CAR-T cells in the treatment of relapsed or refractory plasma cell neoplasms positive for CD70/BCMA based on the determination of the maximum tolerated dose (MTD).
Incidence of dose-limiting toxicity (DLT)
Time frame
Up to 28 days after CAR-T treatmentSecondary outcomes
1
To evaluate the efficacy of CAR70-BCMA CAR-T cells in the treatment of relapsed or refractory plasma cell neoplasms positive for CD70/BCMA based on the objective response rate (ORR).
Objective response rate (ORR) Description: For multiple myeloma (plasma cell neoplasms, plasma cell leukemia), the efficacy evaluation criteria refer to the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (2024 Revision). ORR includes the proportion of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), and minimal response (MR).
Time frame
Within 3 months following infusion of CAR70-BCMA CAR-T cellsOther outcomes
1
To explore the kinetics and clonal evolution of CAR70-BCMA CAR-T cells based on pharmacokinetics (assessing the persistence of CAR-T cells by measuring CAR-T cell counts in peripheral blood).
After infusion of CAR70-BCMA CAR-T cells, the CAR positivity rate in peripheral blood using flow cytometry and measuring CAR-T expression levels with qPCR.
Time frame
Up to 12 months after CAR-T treatmentSponsors and contacts
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Source ClinicalTrials.gov