Final Results Of a Phase I Study Of The Anti-CD22 Antibody-Drug Conjugate (ADC) DCDT2980S With Or Without Rituximab (RTX) In Patients (Pts) With Relapsed Or Refractory (R/R) B-Cell Non-Hodgkin’s Lymphoma (NHL)
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Abstract Background DCDT2980S (DCDT) is an anti-CD22 monoclonal antibody (Ab) conjugated to MMAE, a potent anti-microtubule inhibitor. We have previously reported clinical activity and acceptable toxicity in pts with R/R B-cell NHL treated at DCDT doses of 1.8 and 2.4 mg/kg. The maximum tolerated dose (MTD) was defined as 2.4 mg/kg either as a single agent or in combination with RTX (375 mg/m2) every 21 days (q21d) (Advani et al. ASH 2012, abstract 59). In this report, we provide updated results from pts treated at 1.8 mg/kg as well as an expanded cohort treated at 2.4 mg/kg. Methods We evaluated safety, tolerability, pharmacokinetics (PK), and activity of DCDT q21d with or without RTX (375 mg/m2) in pts with R/R B-cell NHL. Expanded cohorts of pts with R/R diffuse large cell lymphoma (DLBCL) or indolent (i)NHL were evaluated at the single-agent MTD of 2.4 mg/kg q21d. Results Forty-six pts enrolled in DCDT ≥ 1.8 mg/kg (7 at 1.8 mg/kg, 39 at 2.4 mg/kg) and 16 in the DCDT+RTX cohort (5 a
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Abstract Background DCDT2980S (DCDT) is an anti-CD22 monoclonal antibody (Ab) conjugated to MMAE, a potent anti-microtubule inhibitor. We have previously reported clinical activity and acceptable toxicity in pts with R/R B-cell NHL treated at DCDT doses of 1.8 and 2.4 mg/kg. The maximum tolerated dose (MTD) was defined as 2.4 mg/kg either as a single agent or in combination with RTX (375 mg/m2) every 21 days (q21d) (Advani et al. ASH 2012, abstract 59). In this report, we provide updated results from pts treated at 1.8 mg/kg as well as an expanded cohort treated at 2.4 mg/kg. Methods We evaluated safety, tolerability, pharmacokinetics (PK), and activity of DCDT q21d with or without RTX (375 mg/m2) in pts with R/R B-cell NHL. Expanded cohorts of pts with R/R diffuse large cell lymphoma (DLBCL) or indolent (i)NHL were evaluated at the single-agent MTD of 2.4 mg/kg q21d. Results Forty-six pts enrolled in DCDT ≥ 1.8 mg/kg (7 at 1.8 mg/kg, 39 at 2.4 mg/kg) and 16 in the DCDT+RTX cohort (5 a
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