Drugs / ALLO-605
last change Oct 2023 re-read 9 days ago

ALLO-605

Developed for
refractory plasma cell neoplasm
Investigated by
Allogene Therapeutics

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Clinical hold US (FDA) — plasma cell myeloma —

“Following the FDA’s clinical hold, Allogene had announced that it has resumed clinical study activities on ALLO-715 and ALLO-605 for r/r MM” cellectis.com ↗

Trials 1

20222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT05000450 Jun 2021 → Oct 2023 refractory plasma cell neoplasm Allogene Therapeutics Terminated No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2022-04-27 Allogene Therapeutics Regulatory Allogene Therapeutics Receives FDA Orphan-Drug Designation for ALLO-605, its First TurboCAR™ T Cell Product Candidate, for the Treatment of Multiple Myeloma allogene.com ↗
the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation (ODD) to ALLO-605
2022-01-10 Cellectis S.A. Regulatory Cellectis’ Licensed Partner, Allogene Therapeutics, Announces Removal of FDA Clinical Hold on their Clinical Trials cellectis.com ↗
2021-06-30 Allogene Therapeutics Regulatory Allogene Therapeutics Granted FDA Fast Track Designation for ALLO-605, the First TurboCAR™ T Cell Therapy, for the Treatment of Relapsed/Refractory Multiple Myeloma allogene.com ↗
The FDA granted Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard multiple myeloma therapies.
2021-04-19 Allogene Therapeutics Regulatory Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-605, the First TurboCAR™ Candidate, for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma allogene.com ↗
today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study ALLO-605 for the treatment of patients with relapsed or refractory multiple myeloma.
2020-12-07 Allogene Therapeutics Results Allogene Therapeutics Presents Preclinical Findings Supporting ALLO-605, the First Anti-BCMA TurboCAR™ T Cell Therapy, at the 62nd Meeting of the American Society of Hematology allogene.com ↗

Evidence & citations 1 cited value

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as ALLO-605 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05000450 ↗