European journal of cancer (Oxford, England : 1990)
October 17, 2026 · via Europe PMC
Outcomes of CD20-targeting CAR T-cell therapy in patients with advanced melanoma: MB-CART20.1 Melanoma phase I trial.
Balke-Want H, Theurich S, Gödel P, +22 more, von Bergwelt-Baildon M
AI summary — for doctors, generated from the abstract only
CD20 CAR T cells in advanced melanoma caused serious toxicity without durable benefit, ending the phase I trial early.
What was studied
Phase I 3+3 dose-escalation trial of autologous anti-CD20 CAR T-cells (MB-CART20.1) in 7 patients with refractory advanced melanoma after lymphodepletion.
Key findings
- Two of four patients at dose level 2 had dose-limiting toxicities (grade 3 ICANS, grade 4 hepatotoxicity); none at dose level 1.
- Stable disease at week 16 in three patients, all progressing by month 6.
- CAR T-cells expanded robustly, but toxicity and lack of durable response led to termination.
Clinical relevance
Shows the difficulty of CAR T therapy in solid tumours and flags toxicity linked to prior checkpoint inhibitors and B-cell depletion.
Who should care
Limitations
Tiny trial of seven patients, so safety and activity estimates are very imprecise.
CD20 CAR T-cell therapy is not an option for melanoma outside trials; no practice change.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
BACKGROUND
Previous studies identified CD20cells within the melanoma tumor microenvironment, including tumor-associated B-cells and putative cancer stem cells (CSC), as potential therapeutic targets. We therefore evaluated CD20-targeting CAR T-cells in patients with advanced melanoma.
METHODS
This prospective, open-label phase I trial evaluated a 3 +3 design in patients with advanced melanoma, refractory to approved treatments, to assess safety and preliminary activity of autologous anti-CD20 CAR T-cells (MB-CART20.1). Following lymphodepleting chemotherapy, patients received a single MB-CART20.1 infusion. Primary endpoints were safety and tolerability; secondary endpoints included kinetics and early evidence for antitumor activity. Three patients received dose level 1 (DL1) (1.0 ×10⁵ cells/kg) and four patients DL2 (1.0 ×10⁶ cells/kg).
RESULTS
No DLTs occurred at DL1, while two patients experienced DLTs at DL2 (grade 3 ICANS and grade 4 hepatotoxicity). Overall, 43 serious TEAEs were reported across all seven patients. Stable disease was observed in three patients at week 16; all had progressed by month 6. All had received immune checkpoint inhibitors within 6 months before leukapheresis and showed reduced exhaustion marker expression on CD8T-cells. In addition, the frequency of CD19CD24CD27Bcells trended to associate with progressive disease and inversely correlate with toxicity. MB-CART20.1 showed robust in vivo expansion however, severe DLTs at DL2 without durable clinical benefit led to early trial termination.
CONCLUSIONS
In advanced melanoma, MB-CART20.1 was associated with marked expansion and toxicity, suggesting that Bdepletion and the melanoma-typical treatment history might have driven distinct CAR T-associated immunotoxicities.
DOI
10.1016/j.ejca.2026.117780
PMID
42913258
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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