. 2023 Oct 20;31:101125. doi: 10.1016/j.omtm.2023.101125

Table 1.

CAR T cell therapy clinical holds

Sponsor/Program/Trial identifier #	Target disease	Dates of hold	Reason for hold	Status/Conclusions
Beam Therapeutics¹⁰ BEAM-201 N/A	T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LL)	July-22 – Dec-22	IND was submitted end of June 2022 and hold was placed prior to trial start. Insufficient information in the original IND to assess subject safety.	FDA requested: (1) additional control data from genomic rearrangement assessments; (2) further analyses of certain off-target editing experiments; (3) additional control data for a cytokine independent growth assay; and (4) an updated investigator brochure that includes information regarding any new nonclinical studies.
Legend Biotech¹¹^,¹² LB1901 NCT04712864	T cell lymphoma	Feb-22 – May-22 – Study terminated	First patient treated experienced low CD4+ T cell counts.	Company reported that FDA stated the IND does not contain sufficient information required by 21 CFR 312.23 to assess the risks to subjects. Legend Biotech voluntarily ended the trial in July 2022.
Atara¹³ ATA2271 NCT04577326	Pleural mesothelioma	Feb-22 – Nov-22	Patient in higher dose arm died.	Clinical strategy reassessed as FDA recommended the sponsor run a clinical study with the commercial product as comparability had not been demonstrated.
Celyad Oncology¹⁴^,¹⁵^,¹⁶ CYAD-101-002 NCT04991948	Metastatic colorectal cancer	Feb-22 – Aug-22	Two patient deaths with similar pulmonary findings.	Insufficient information to assess risk to study subjects. Hold was lifted after changes were made to eligibility criteria.
Allogene¹⁷^,¹⁸ ALLO-501A NCT04416984	Non-Hodgkin lymphoma	Oct-21 – Jan-22	One patient showed evidence of chromosomal abnormality.	Determined abnormality was not related to CAR T (no abnormality in manufactured product or any other patient).
Tmunity¹⁹ PSMA-TGFbRDN auto NCT03089203	Prostate cancer	Jun-21 – Stopped	Two patient deaths due to neurotoxicity from over-reactive immune response.	Permanently stopped clinical trial—working on development of another similar therapy designed to have an improved safety profile.
Bellicum²⁰^,²¹ BXP-601 NCT02744287	Pancreatic and prostate tumors expressing prostate stem cell antigen (PSCA)	Dec-20 – Jan-21	Death of a pancreatic cancer patient in the trial.	Concluded that patient death was unrelated to BXP-601.
Poseida²²^,²³ P-PSMA-101 NCT04249947	Prostate cancer	Aug-20 – Nov-20	Patient died from liver failure. Failure appeared to come from macrophage activation syndrome (MAS) that was exacerbated by patient noncompliance.	Protocol amendments intended to increase patient compliance and safety including modified inclusion and exclusion criteria and frequency of monitoring and laboratory testing.
Cellectics²⁴^,²⁵ UCARTCS1A NCT04142619	Multiple myeloma	Jul-20 – Nov-20	Patient suffered a fatal cardiac arrest after receiving the highest dose of the allogenic CAR T.	"Adjusted clinical protocol"; no specific details were provided.