European journal of cancer (Oxford, England : 1990) · 2026
Acute and long-term outcomes of CD20-targeting CAR T-cell therapy in relapsed or refractory B-NHL: MB-CART20.1 Lymphoma phase I trial.
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Kutsch Nadine, Balke-Want Hyatt, Biedermann Stefanie, Franke Georg-Nikolaus, Vučinić Vladan, Altefrohne Florentine Pia, Schubert Christine, Kampfenkel Tobias, Wennborg Anders, Haverkamp Heinz, Gao Liang, Holzer Tatjana, Novak Ben, Borchmann Peter, Gödel Philipp
Аннотация
INTRODUCTION: Anti-CD19 CAR T-cell therapy has improved outcomes in B-cell non-Hodgkin lymphoma (B-NHL), but only about half of patients achieve durable benefit. As CD20 is expressed in > 90% of B-NHL, this phase I trial evaluated the CD20-directed CAR T-cell product MB-CART20.1 in adults with relapsed/refractory CD20-positive B-NHL without curative treatment options.
METHODS: In this phase I dose-escalation trial, patients received 1.0 × 10⁵ cells/kg body weight (BW) MB-CART20.1 at the safety dose level (SDL) or 1.0 × 10⁶ cells/kg BW at dose level 1 (DL1).
RESULTS: Recruitment was terminated early because of the COVID-19 pandemic after nine heavily pretreated patients had received MB-CART20.1 (SDL n = 7; DL1 n = 2). Diagnoses included transformed follicular lymphoma (n = 4), diffuse large B-cell lymphoma (n = 3), Richter transformation from chronic lymphocytic leukemia (CLL, n = 1), and small lymphocytic lymphoma (n = 1). One dose-limiting toxicity (DLT; grade 4 neutropenia) occurred at DL1; the maximum tolerated dose was not determined. No grade ≥ 3 cytokine release syndrome occurred (grade 1: n = 4; grade 2: n = 1). One patient developed grade 2 immune effector cell-associated neurotoxicity syndrome. The best overall response rate was 56%, including 33% complete responses (CR; SDL n = 1; DL1 n = 2). CRs were durable, with one maintained through 5 years of follow-up. CAR T-cells showed robust expansion, with higher Cmax at DL1 than SDL (125.9 vs. 3.1 cells/µL). Cmax and AUC0-28D were higher in responders (p = 0.0369).
CONCLUSION: With manageable toxicity, no DLTs at SDL, and preliminary signs of efficacy in the overall trial cohort, these findings warrant further investigation of CD20-directed CAR T-cell therapy in relapsed/refractory B-NHL.
METHODS: In this phase I dose-escalation trial, patients received 1.0 × 10⁵ cells/kg body weight (BW) MB-CART20.1 at the safety dose level (SDL) or 1.0 × 10⁶ cells/kg BW at dose level 1 (DL1).
RESULTS: Recruitment was terminated early because of the COVID-19 pandemic after nine heavily pretreated patients had received MB-CART20.1 (SDL n = 7; DL1 n = 2). Diagnoses included transformed follicular lymphoma (n = 4), diffuse large B-cell lymphoma (n = 3), Richter transformation from chronic lymphocytic leukemia (CLL, n = 1), and small lymphocytic lymphoma (n = 1). One dose-limiting toxicity (DLT; grade 4 neutropenia) occurred at DL1; the maximum tolerated dose was not determined. No grade ≥ 3 cytokine release syndrome occurred (grade 1: n = 4; grade 2: n = 1). One patient developed grade 2 immune effector cell-associated neurotoxicity syndrome. The best overall response rate was 56%, including 33% complete responses (CR; SDL n = 1; DL1 n = 2). CRs were durable, with one maintained through 5 years of follow-up. CAR T-cells showed robust expansion, with higher Cmax at DL1 than SDL (125.9 vs. 3.1 cells/µL). Cmax and AUC0-28D were higher in responders (p = 0.0369).
CONCLUSION: With manageable toxicity, no DLTs at SDL, and preliminary signs of efficacy in the overall trial cohort, these findings warrant further investigation of CD20-directed CAR T-cell therapy in relapsed/refractory B-NHL.