To find the highest tolerable dose of dualCAR-NK19/70 (a type of cell therapy) that can be given to patients who have B-cell lymphoma that is relapsed or refractory.
Primary Objectives: --The primary objective is to determine the safety and identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of dualCAR-NK19/70 in patients with r/r B-cell lymphomas. Hypothesis: DualCAR-NK19/70 will be safe, well-tolerated, and effective in patients with r/r B-cell lymphomas. Secondary Objectives: --The secondary objective is to determine the efficacy in adults with r/r LBCL and FL grade 3B treated at the MTD or RP2D of dualCAR-NK19/70. Although the clinical benefit of dualCAR-NK19/70 has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Secondary endpoints include overall response rate (ORR; including CR + PR) and CR rate as defined by the Lugano Classification response criteria for malignant lymphoma, DOR, PFS, and OS. Exploratory Objectives: --The exploratory objectives are to assess the cellular kinetics and pharmacodynamic effects of dualCAR-NK19/70 and to evaluate biomarkers associated with response, resistance, and toxicity after administration of dualCAR-NK19/70 in blood and tumor samples.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Given by IV (vein)
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGincidence of dose limiting toxicity(DLTs)
To evaluate the safety,tolerabitility,and determine the recommended dosage of cord blood-derived CAR NK cells targeting CD19/CD70
Time frame: up to 28 days
Objective Response Rate(ORR)
To determine the anti-tumor effectivity of CB dualCAR-NK19/70
Time frame: 6 months
Complete Remission Rate(CRR)
To determine the anti-tumor effectivity of CB dualCAR-NK19/70
Time frame: 3 months
Overall survival(OS)
To determine the anti-tumor effectivity of CB dualCAR-NK19/70
Time frame: Up to 3 years
Duration of Response(DOR)
To determine the anti-tumor effectivity of CB dualCAR-NK19/70
Time frame: Up to 3 years
progression-free survival(PFS)
To determine the anti-tumor effectivity of CB dualCAR-NK19/70
Time frame: Up to 3 years
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