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. |
Status | Open for dose level 3. |
Participants | UMC Utrecht (Dr. L.E. van der Wagen) |
Study docs |
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 |
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: |
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 |