Leukemia Associated studies

Open trials

Short name	MB-dNPM1-TCR.1 in R/R AML
Title	A phase I/II trial of MB-dNPM1-TCR.1 in HLA-A*02:01-positive patients with relapsed or refractory NPM1-mutated AML to determine safety and obtain first data on efficacy
Phase	Phase I/II
Therapy	dNPM1-TCR T cells (patient-derived T cells transduced with a T cell receptor recognizing peptides from mutated NPM1 in HLA-A02
Objectives	MTD, Best Objective Responses (Phase II)
Population	R/R Npm1 mutated AML, HLA-A02
Eligibility	Pre end post alloTx
Status	Open August 2024
Participants	LUMC (Dr. C.J.M.Halkes)
Reference	https://clinicaltrials.gov/study/NCT06424340

Short name	TEG001 in patients with r/r AML/high-risk MDS or r/r MM
Title	A phase I study to investigate the safety and tolerability of TEG001 cell suspension for infusion in patients with relapsed/refractory Acute Myeloid Leukemia (AML)/high-risk Myelodysplastic Syndrome (MDS) (IPSS-R > 4.5) or relapsed/refractory Multiple Myeloma (MM)
Phase	Phase I
Therapy	TEG001 cell suspension (T cells engineered to express a defined gamma/delta T cell receptor)
Objectives	MTD, safety, tolerability, feasibility, efficacy, kinetics, persistence
Population	Adults with relapsed/refractory Acute Myeloid Leukemia (AML)/high-risk Myelodysplastic Syndrome (MDS) (IPSS-R > 4.5) or relapsed/refractory Multiple Myeloma (MM)
Eligibility	No remaining therapeutic treatment options available. - Additional eligibility criteria in protocol.
Status	Open for dose level 3.
Participants	UMC Utrecht (Dr. L.E. van der Wagen)
Study docs	Protocol synopsis In- exclusion criteria

Short name	Molecular Partners MP0533
Phase	Phase 1 (escalation/expansion)
Therapy	MP0533 A multispecific CD3 x CD33 x CD123 x CD70 DARPin
Objectives	MTD, Safety, RP2D
Population	R/R AML and MDS-EB2
Eligibility	pre- and post allo-Tx
Status	open
Participants	ErasmusMC (Jongen-Lavrencic), UMCG (Huls), UMC Amsterdam (de Leeuw)
Reference	https://clinicaltrials.gov/study/NCT05673057

Short name	Sanofi TCD17197
Phase	Phase 1/2
Therapy	SAR443579 is a bispecific NK cell and CD123-engager
Objectives	MTD, Safety, RP2D
Population	R/R AML, MDS IPSS-R interim/high, B-ALL (CD123 pos)
Eligibility	pre- and post allo-Tx
Status	open (slots)
Participants	ErasmusMC (Jongen-Lavrencic), UMCG (Huls), UMC Amsterdam (de Leeuw), Radboudumc (Langemeijer)
Reference	https://clinicaltrials.gov/study/NCT05086315

Short name	Ellipses
Phase	Phase I/IIA
Therapy	dual FLT-3 and Aurora Kinase oral inibitor
Objectives	MTD, Safety
Population	R/R AML
Eligibility	pre- and post allo-Tx
Status	open
Participants	ErasmusMC (Jongen-Lavencic), UMC Amsterdam (de Leeuw), UMCG (Huls)
Reference	https://clinicaltrials.gov/study/NCT04581512

Short name	SGNS70-101 AML
Phase	Phase I Study of SEA-CD70 in Myeloid Malignancies
Therapy	SEA-CD70 + azacitidine combination cohort in previously untreated higher-risk MDS (Parts D and E)
Objectives	Safety
Population	R/R MDS R/R AML
Eligibility	Subjects with previously untreated cytologically/histologically confirmed MDS according to the 2016 WHO classification with the following o Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria as defined either: § 5%–9% blasts in the bone marrow or 2%–4% blasts in the peripheral blood (MDS-EB-1), or § 10%–19% blasts in the bone marrow or 5%–19% blasts in the peripheral blood (MDS-EB-2) o Subjects with higher-risk (Intermediate-2 or High risk) MDS per the International Prognostic Scoring System (IPSS). o Age ≥18 years. o ECOG Performance status of 0–2.
Status	open
Participants	UMCU (v Rhenen)

Short name	R/R B-ALL blina and PD1 remmer
Title	A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Phase	Phase 1b
Therapy	Administration of Blinatumomab in Combination With AMG 404
Objectives	Safety, Tolerability, Pharmacokinetics and Efficacy
Population	Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Inclusion criteria	Age ≥ 18 years at enrollment. Subjects with B-precursor ALL, with any of the following: ● Refractory to primary induction or refractory to salvage therapy. ● In untreated first, second or greater relapse or refractory relapse or relapse after salvage therapy ● Relapse at any time after allogeneic HSCT – Relapse is defined as achievement of CR (CR1) during upfront therapy then relapse during or after continuation therapy. – Refractory disease is defined as the absence of CR after standard induction therapy. – Refractory relapse lack of CR after first salvage therapy – Second relapse or later relapse defined as relapse after achieving a second CR (CR2) in first or later salvage. Greater than or equal to 5% blasts in the BM. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2. Subjects with relapsed or refractory B Cell ALL Ph+ disease and that are intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.
Status	Open
Reference	Clinicaltrials.gov
Participants	UMCG (Dr. M. Bellido)

Short name	NK4AML
Title	Administration of ex vivo generated allogeneic natural killer cells in combination with subcutaneous IL-2 in patients with AML
Phase	Phase I/IIa
Therapy	Cy/Flu + NK cells with and without subcutaneous IL-2 (phase 1 ramp up dose IL-2)
Objectives	Safety and clinical efficacy
Population	AML or MDS EB-2 with stable or non-rapidly progressive disease without or with disease inhibitory medication
Eligibility	Newly diagnosed or Relapsed/Refractory AML: Eligibility criteria in protocol
Status	Open
Reference	Clinicaltrials.gov: NCT04347616
Participants	Radboudumc (Dr. N.P.M. Schaap, Dr. M. Roeven): www.radboudumc.nl/nk4aml
Study docs	Synopsis

Short name	FLAMSA-TCD-RIC met sequentieel DLI on d90 en d180 (investigator initiated, non-industrial)
Phase	Phase 2
Therapy	FLAMSA-TCD-RIC-allo-Tx with DLI singel arm
Objectives	Safety (to reach DLI and NRM)
Population	age 60-75 years primary refractory and relaps AML and high risk MDS
Eligibility	pre-allo-Tx
Status	open
Participants	LUCM (Veelken)

Short name	DCOne-002
Study title	An international, multicentre open-label study to evaluate the efficacy and safety of two different vaccination regimens of immunotherapy with allogeneic dendritic cells, dcp-001, in patients with acute myeloid leukaemia that are in remission with persistent mrd
Status	Open
Participants	AmsterdamUMC - VUmc, Prof. Dr. A.A. van de Loosdrecht UMC Groningen, Prof. Dr. G. Huls
Study docs	Protocol Eligibility criteria

Short name	AvenCell UniCAR (UC02-123-01)
Phase	Phase 1 (escalation/expansion)
Therapy	UniCAR02-T-CD123 in combination with a recombinant antibody derivative (TM123)
Objectives	MTD, Safety, RP2D
Population	R/R AML
Eligibility	pre- and post allo-Tx
Status	open
Participants	ErasmusMC (Jongen-Lavrencic), UMCG (Huls) UMC Amsterdam (de Leeuw)
Reference	https://clinicaltrials.gov/study/NCT04230265

Short name	Biomea Fusion BMF-219
Phase	Phase 1 (escalation/expansion)
Therapy	BMF-219, Menin inhibitor
Objectives	MTD, Safety, RP2D
Population	R/R AML R/R B-ALL, DLBCL, MM
Eligibility	pre- and post allo-Tx
Status	pending
Participants	ErasmusMC (Jongen-Lavrencic), UMCG (Huls) UMC Amsterdam (de Leeuw)
Reference	https://clinicaltrials.gov/study/NCT05153330

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