ArticlePloS one2018
cGMP production of astatine-211-labeled anti-CD45 antibodies for use in allogeneic hematopoietic cell transplantation for treatment of advanced hematopoietic malignancies.
Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03128034 (A Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10), which is not on this map. Cited by 20 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10 (211^At-BC8-B10) Followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS)
Who cites it
20 citing papers in PubMed, 35 citations in OpenAlex.
- Uptake and Binding of At-211 Into K- and Cs-Derivatives of Alpha-Zirconium Phosphate Nanoplatelets for Use as a Targeted Alpha Therapy Delivery Platform.Small science · 2026Article
- Astatine-211 and actinium-225: two promising nuclides in targeted alpha therapy.Acta biochimica et biophysica Sinica · 2024Review
- Astatine-211 radiolabelling chemistry: from basics to advanced biological applications.EJNMMI radiopharmacy and chemistry · 2024Review
- The Different Strategies for the Radiolabeling of [Pharmaceutics · 2024Review
- A proposed production method for astatinated (At-211) Trastuzumab for use in a Phase I clinical trial.PloS one · 2024Article
- Tumor Targeting ofMolecular pharmaceutics · 2023Article
- Development of radiopharmaceuticals for targeted alpha therapy: Where do we stand?Frontiers in medicine · 2022Review
- Astatine-211 based radionuclide therapy: Current clinical trial landscape.Frontiers in medicine · 2022Review
- Nanoradiopharmaceuticals Based on Alpha Emitters: Recent Developments for Medical Applications.Pharmaceutics · 2021Review
- Overview of the Most Promising Radionuclides for Targeted Alpha Therapy: The "Hopeful Eight".Pharmaceutics · 2021Review
- Stabilization of anACS omega · 2021Article
- Radiopharmaceutical Chemistry and Drug Development-What's Changed?Seminars in radiation oncology · 2021Review
- Targeted Alpha Therapy: Progress in Radionuclide Production, Radiochemistry, and Applications.Pharmaceutics · 2020Review
- Radiopharmaceutical therapy in cancer: clinical advances and challenges.Nature reviews. Drug discovery · 2020Review
- Realizing Clinical Trials with Astatine-211: The Chemistry Infrastructure.Cancer biotherapy & radiopharmaceuticals · 2020Review
- Investigation of a tellurium-packed column for isolation of astatine-211 from irradiated bismuth targets and demonstration of a semi-automated system.Scientific reports · 2019Article
- The α-emitter astatine-211 targeted to CD38 can eradicate multiple myeloma in a disseminated disease model.Blood · 2019Article
- In vitro evaluation of anti-HIV radioimmunoconjugates labeled with astatine-211, thorium-227 and actinium-225.Nuclear medicine and biologyArticle
- A third generation PSMA-targeted agent [Nuclear medicine and biologyArticle
- Production, purification and availability ofNuclear medicine and biologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 2 institutions in 1 country.
Funding
Abstract
The objective of this study was to translate reaction conditions and quality control methods used for production of an astatine-211(211At)-labeled anti-CD45 monoclonal antibody (MAb) conjugate, 211At-BC8-B10, from the laboratory setting to cGMP production. Five separate materials were produced in the preparation of 211At-BC8-B10: (1) p-isothiocyanato-phenethyl-closo-decaborate(2-) (B10-NCS), (2) anti-CD45 MAb, BC8, (3) BC8-B10 MAb conjugate, (4) [211At]NaAt, and (5) 211At-BC8-B10. The 211At-labeling reagent, B10-NCS, was synthesized as previously reported. BC8 was produced, then conjugated with B10-NCS under cGMP conditions to form BC8-B10. [211At]NaAt was produced by α-irradiation of Bi targets, followed by isolation of the 211At using a "wet chemistry" method. The clinical product, 211At-BC8-B10, was prepared by reacting [211At]NaAt with BC8-B10 in NH4OAc buffer (pH 5.5) for 2 min at room temperature, followed by size-exclusion chromatography purification. Quality control tests conducted on the 211At-BC8-B10 included evaluations for purity and identity, as well as pyrogen and sterility tests. Stability of the 211At-BC8-B10 in 25 mg/mL sodium ascorbate solution was evaluated at 1, 2, 4, 6 and 21 h post isolation. For qualification, three consecutive 211At-BC8-B10 clinical preparations were successfully conducted in the cGMP suite, and an additional cGMP clinical preparation was carried out to validate each step required to deliver 211At-BC8-B10 to a patient. These cGMP preparations provided 0.80-1.28 Gbq (21.5-34.5 mCi) of 211At-BC8-B10 with radiochemical purity of >97%. The preparations were found to be sterile and have a pyrogen level <0.50 EU/mL. Cell binding was retained by the 211At-BC8-B10. 211At-BC8-B10 in ascorbic acid solution demonstrated a radiochemical stability of >95% for up to 21 h at room temperature. The experiments conducted have defined conditions for translation of 211At-BC8-B10 production from the laboratory to cGMP suite. This study has allowed the initiation of a phase I/II clinical trial using 211At-BC8-B10 (NCT03128034).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.