ArticleMolecular therapy : the journal of the American Society of Gene Therapy2023
Replication competent retrovirus testing (RCR) in the National Gene Vector Biorepository: No evidence of RCR in 1,595 post-treatment peripheral blood samples obtained from 60 clinical trials.
Article in Molecular therapy : the journal of the American Society of Gene Therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed.
- Gammaretrovirus Infections in Humans in the Past, Present, and Future: Have We Defeated the Pathogen?Pathogens (Basel, Switzerland) · 2026Review
- Risks of replication-competent retro/lentivirus from associated vector systems: Is it time for a roadmap toward reduced testing?Molecular therapy. Methods & clinical development · 2025Review
- The design of retroviral vectors used in the CAR-T products, risk management, and future perspective.MedComm · 2025Article
- CAR-NK cell therapy: promise and challenges in solid tumors.Frontiers in immunology · 2025Review
- Risk of T-cell malignancy after CAR T-cell therapy in children, adolescents, and young adults.Blood advances · 2024Article
- Current understanding and management of CAR T cell-associated toxicities.Nature reviews. Clinical oncology · 2024Review
- Unanswered questions following reports of secondary malignancies after CAR-T cell therapy.Nature medicine · 2024Article
- Long-term follow-up of CD19-CAR T-cell therapy in children and young adults with B-ALL.Hematology. American Society of Hematology. Education Program · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
31 authors.
Funding
Abstract
The clinical impact of any therapy requires the product be safe and effective. Gammaretroviral vectors pose several unique risks, including inadvertent exposure to replication competent retrovirus (RCR) that can arise during vector manufacture. The US FDA has required patient monitoring for RCR, and the National Gene Vector Biorepository is an NIH resource that has assisted eligible investigators in meeting this requirement. To date, we have found no evidence of RCR in 338 pre-treatment and 1,595 post-treatment blood samples from 737 patients associated with 60 clinical trials. Most samples (75%) were obtained within 1 year of treatment, and samples as far out as 9 years after treatment were analyzed. The majority of trials (93%) were cancer immunotherapy, and 90% of the trials used vector products produced with the PG13 packaging cell line. The data presented here provide further evidence that current manufacturing methods generate RCR-free products and support the overall safety profile of retroviral gene therapy.
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.