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dose-limiting toxicities (DLTs)

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DLTs

Evidence Snippets

the US Food and Drug Administration (FDA) recently published Guidance for Industry, which included suggested definitions for dose-limiting toxicities (DLTs) for clinical trials of emerging CAR T therapies.
Evidence 1Source 1DOIPubMedprovenance

Supporting Sources

Linked Claims

Claim 1development impactsupports2025Source 1DOIPubMed

Using the FDA guidance DLT definitions could have prematurely stopped early-phase studies of now approved CAR T therapies.

Quoted textsource-backed
Using DLT definitions from the guidance could have prematurely stopped the early-phase studies of the now approved CAR Ts.
Claim 2recommendationsupports2025Source 1DOIPubMed

The paper presents revised DLT recommendations that permit reversible events during dose escalation in future CAR T therapy trials.

Quoted textsource-backed
This led the panel to draft the revised recommendations contained herein, which integrate the permissibility of reversible events during dose-escalation for trial sponsors, investigators, health authorities, and other parties who may be involved in future CAR T therapy trials.
Claim 3regulatory comparisonsupports2025Source 1DOIPubMed

The FDA guidance DLT definitions do not reflect the DLT definitions used in phase 1 and/or registrational studies for approved CAR T products.

Quoted textsource-backed
However, the DLT definitions in the guidance do not reflect what was used in the phase 1 and/or registrational studies for the approved CAR Ts
Claim 4safety contextsupports2025Source 1DOIPubMed

CAR T therapies are associated with acute class-effect toxicities including cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome, and these remain significant concerns despite potential reversibility.

Quoted textsource-backed
Acute class-effect toxicities, such as cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome, remain significant concerns despite their potential reversibility.