TAK-012 / Takeda - LARVOL DELTA

TAK-012-1501: A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=16 | Terminated | Sponsor: Takeda | Trial completion date: May 2026 ➔ Nov 2025 | Active, not recruiting ➔ Terminated; Sponsor decision (No safety concern)

Trial completion date • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TAK-012-1501: A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=14 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting | N=53 ➔ 14 | Trial completion date: Jun 2027 ➔ May 2026 | Trial primary completion date: Apr 2026 ➔ Aug 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=53 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=53 | Not yet recruiting | Sponsor: Takeda

New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

GDX012U-001 A phase 1, open-label, dose escalation, and dose expansion study to assess the safety, tolerability, and preliminary antileukemic activity of GDX012 in patients with MRD positive AML (AACR 2022) - P1 | "Eligible patients will undergo lymphodepletion with fludarabine for 4 days and cyclophosphamide for 3 days followed by infusion of GDX012. Up to 34 patients will be enrolled across 6 US sites. Recruitment to Cohort 1 is ongoing."

Clinical • Minimal residual disease • P1 data • Acute Myelogenous Leukemia • Oncology • PTPRC

GDX012U-001: Study of GDX012 in Patients With MRD Positive AML (clinicaltrials.gov) - P1 | N=3 | Terminated | Sponsor: GammaDelta Therapeutics Limited | N=28 ➔ 3 | Trial completion date: Aug 2024 ➔ Jun 2022 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Jun 2022; This was a business decision to discontinue this clinical trial. The decision is not related to the safety of the investigational product, GDX012.

Enrollment change • Minimal residual disease • Trial completion date • Trial primary completion date • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Takeda to Acquire GammaDelta Therapeutics to Accelerate Development of Allogeneic γδT Cell Therapies Addressing Solid Tumors (Businesswire) - "Takeda Pharmaceutical Company Limited...today announced the exercise of its option to acquire GammaDelta Therapeutics Limited...Through the acquisition, Takeda will obtain GammaDelta’s allogeneic variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy platforms, which includes both blood-derived and tissue-derived platforms, in addition to early-stage cell therapy programs....The deal is expected to be finalized in Q1 of Takeda’s fiscal year 2022."

M&A • Hematological Malignancies • Oncology

GammaDelta Therapeutics Initiates First-in-Human Phase 1 Trial of GDX012 for the Treatment of Acute Myeloid Leukaemia (Businesswire) - “GammaDelta Therapeutics Ltd…announced that it has initiated a first-in-human Phase I clinical trial evaluating GDX012 for the treatment of acute myeloid leukaemia (AML)….GDT’s Phase I trial, conducted in the U.S., is an open-label, multi-centre study of GDX012 enrolling adults diagnosed with AML and presenting with measurable residual disease (MRD) after standard of care (SOC) treatment.”

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Study of GDX012 in Patients With MRD Positive AML (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: GammaDelta Therapeutics Limited

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

GammaDelta Therapeutics Receives FDA Clearance of IND Application for GDX012, a Novel Allogeneic Variable Delta 1 Gamma-delta T Cell Cancer Therapy (PRNewswire) - “GammaDelta Therapeutics…announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Company’s allogeneic variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy, GDX012, to be investigated as a treatment for haematological malignancies…GammaDelta plans to initiate a Phase 1 clinical trial for patients with measurable residual disease (MRD) positive AML. Expected to begin later in 2021…”

IND • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology