CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese PLA General Hospital
About this trial
This is a single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years,
no gender restrictions;
ECOG score ≤ 2 points;
Expected survival period is not less than 3 months;
Disqualifiers
Severe heart failure with left ventricular ejection fraction <50%;
A history of severe lung function impairment; Combined with other advanced malignant tumors;
Complicated with severe infection that could not be effectively controlled;
Severe autoimmune disease or congenital immune deficiency;
Trial design
Design model
Single group
Treatments tested in this trial
CAR19BCMA-T cells
Other interventionCAR19BCMA-T cells Each subject will be infused with single dose of CD19BCMA-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 1×10\^6 /kg, the medium dose is 2×10\^6 /kg, and the high dose is 3×10\^6 /kg. Drug: fludarabine and cyclophosphamide Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: This is a single arm treatment of CAR19BCMA CAR-T cellExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+plasma cell neoplasms.
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
Time frame
up to 3 years2
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.
Time frame
MTD will be determined based on DLTs observed during the first 28 days of study treatmentSecondary outcomes
1
According to the objective response rate (ORR) to evaluate the efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.
Overall response rate (ORR) Description: Multiple myeloma (plasma cell neoplasms, plasma cell leukemia) refers to the efficacy evaluation criteria in the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (revised in 2024),ORR includes strictly defined proportions of 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 CAR19BCMA CAR-T cellsOther outcomes
1
According to the pharmacokinetics (number of CAR-T cells in peripheral blood was measured to evaluate the persistence of CAR-T cells) to explore the kinetics and clonal evolution of CAR19BCMA CAR-T cells.
Time frame
Up to 12 months after CAR-T treatmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: