ArticleNature medicine2023
CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial.
Article in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04503278 (Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of CLDN6 CAR-T With or Without CLDN6 RNA-LPX in Patients With CLDN6-positive Relapsed or Refractory Advanced Solid Tumors), which is not on this map. Cited by 197 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of CLDN6 CAR-T With or Without CLDN6 RNA-LPX in Patients With CLDN6-positive Relapsed or Refractory Advanced Solid Tumors
Who cites it
197 citing papers in PubMed, 4 syntheses or guidelines pooled it, 236 citations in OpenAlex.
- Novel PET tracers to distinguish the nature of residual masses after the completion of chemotherapy in metastatic testicular germ cell tumours: A systematic review.European journal of nuclear medicine and molecular imaging · 2026Pooled it
- Prostate cancer and CAR-T therapy: a systematic review.BMC cancer · 2026Pooled it
- Comparative efficacy, immune response, and safety of mRNA versus dendritic cell vaccines in solid tumors: a systematic review and meta-analysis.Journal of translational medicine · 2026Pooled it
- The safety and efficacy of chimeric antigen receptor-T cell therapy in solid malignancies: a systematic review and meta-analysis.Frontiers in immunology · 2026Pooled it
- Autologous multiantigen-targeted T cell therapy for pancreatic cancer: a phase 1/2 trial.Nature medicine · 2026Trial
- Olaparib as a rescue treatment in platinum-refractory germ-cell tumors: the IGG-02 phase II trial.ESMO open · 2025Trial
- Article
- Towards mRNA therapeutics 2.0.Nature reviews. Drug discovery · 2026Review
- Recent advancements and persisting challenges in the evolution of next generation car t cell therapy for solid malignancies: a comprehensive review.Immunologic research · 2026Review
- RNA therapeutics: current status and future directions.Signal transduction and targeted therapy · 2026Review
- An inducible signal 1 booster overcomes limited access to antigen for solid tumor cell therapy.Molecular therapy. Oncology · 2026Article
- Targeting Regnase-1 in B7-H3-CAR T cells reprograms the tumor microenvironment and enhances antitumor efficacy for osteosarcoma.Cell reports. Medicine · 2026Article
- Targeting claudins in cancer.Nature reviews. Drug discovery · 2026Review
- The evolving role of cytokines for CAR-T cell manufacturing and beyond.Nature biomedical engineering · 2026Review
- Antigen Spreading via Localized Administration Enhances Adoptive TCR-T Cell Therapy in Pancreatic Cancer.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- HBsAg-tagged tumour vaccine system eliminates solid tumours through virus-specific memory T cells.Nature biomedical engineering · 2026Article
- A workflow for assessing antibody-drug conjugate target expression on circulating tumour cells from triple-negative breast cancer and epithelial ovarian cancer patients.The journal of liquid biopsy · 2026Article
- mRNA-based immunotherapy improves the efficacy of adoptively transferred TCR transgenic T cells in a murine solid tumour model.Scientific reports · 2026Article
- Proteomic Profiling Identifies CLDN3 as a Tumor-Selective Therapeutic Target in Small Cell Lung Cancer.bioRxiv : the preprint server for biology · 2026Article
- Mechanisms, optimization strategies, and salvage options for CAR-T cell therapy.Biomarker research · 2026Review
137 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
30 authors at 11 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The oncofetal antigen Claudin 6 (CLDN6) is highly and specifically expressed in many solid tumors, and could be a promising treatment target. We report dose escalation results from the ongoing phase 1/2 BNT211-01 trial evaluating the safety and feasibility of chimeric antigen receptor (CAR) T cells targeting the CLDN6 with or without a CAR-T cell-amplifying RNA vaccine (CARVac) at two dose levels (DLs) in relapsed/refractory CLDN6-positive solid tumors. The primary endpoints were safety and tolerability, maximum tolerated dose and recommended phase 2 dose (RP2D). Secondary endpoints included objective response rate (ORR) and disease control rate. We observed manageable toxicity, with 10 out of 22 patients (46%) experiencing cytokine release syndrome including one grade 3 event and 1 out of 22 (5%) with grade 1 immune effector cell-associated neurotoxicity syndrome. Dose-limiting toxicities occurred in two patients at the higher DL, resolving without sequelae. CAR-T cell engraftment was robust, and the addition of CARVac was well tolerated. The unconfirmed ORR in 21 evaluable patients was 33% (7 of 21), including one complete response. The disease control rate was 67% (14 of 21), with stable disease in seven patients. Patients with germ cell tumors treated at the higher DL exhibited the highest response rate (ORR 57% (4 of 7)). The maximum tolerated dose and RP2D were not established as the trial has been amended to utilize an automated manufacturing process. A repeat of the dose escalation is ongoing and will identify a RP2D for pivotal trials. ClinicalTrials.gov Identifier: NCT04503278 .
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.