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 or MRD positive 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 |
| Study Docs |
| 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), AmsterdamUMC (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), AmsterdamUMC (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), AmsterdamUMC (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 1L MDS? |
| 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), AmsterdamUMC (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), AmsterdamUMC (de Leeuw) |
| Reference | https://clinicaltrials.gov/study/NCT05153330 |
| Short name | BYON4413 |
| Title | A first-in-human dose escalation and expansion trial with the antibody-drug conjugate BYON4413 to evaluate safety, pharmacokinetics, and preliminary efficacy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic neoplasms. |
| Phase | Phase I |
| Therapy | Anti-CD123 tageting antibody-drug conjugate |
| Objectives | Phase 1: dose finding, Phase 2: safety en preliminary efficacy |
| Population | Relapsed/refractory acute myeloid leukemia or myelodysplastic neoplasms (no establlished alternatives) |
| Eligibility | Standard |
| Status | Open for inclusion (slots available by predefined order, possibilty to be placed on waiting list) |
| Participants | UMCG |
|
Reference |
https://clinicaltrials.gov/search?intr=BYON4413 |
| Short name | Biomea Covalent-101 |
| Title | A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF[1]219, an oral, covalent, menin inhibitor, in adult patients with acute leukemia (AL), diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) |
| Phase | Phase 1 |
| Therapy | Oral, covalent, menin inhibitor |
| Objectives | Dose finding, safety, premilinary efficacy |
| Population | R/R acute leukemia (MLL1r [KMT2A], nucleophosmin 1 [NPM1], or other genetic mutations as specified), DLBCL, MM, or CLL/SLL, at least one SOC therapy incl. HCT |
| Eligibilty | Standard |
| Status | Open for inclusion (Enrollment slot availability as of 30Sep2024 1 Open Slot in Cohort 1 (Acute Leukemia) Sub-Cohort 2 (NPM1 only)) |
| Participants | UMCG |
| Short name | AVC-201-01 |
| Title | Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T cells Carrying Reverse Chimeric Antigen Receptors (Allo-RevCAR01-T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With Selected Hematologic Malignancies Positive for CD123 |
| Phase | Phase 1 |
| Therapy | CAR T-cel (CD123 target module) |
| Objectives | Safety, dose finding, response |
| Population | R/R AML with CD123+ (after or ineligible for alloHCT) |
| Eligibilty | standard |
| Status | awaited Q4 2024 |
| Participants | UMCG |
| Short name | Udance |
| Study title | A phase I/II post-cord blood HCT dendritic cell vaccination trial directed against WT1 for pediatric and young adult acute myeloid leukemia: the U-DANCE-anti-AML trial |
| Phase | l-ll |
| Therapy | Denditic cell vaccination 3x, md eform cord blood donor |
| Objectives | 1) determining safe dose. (2)And increasing DFS with 20% |
| Population | 12-20 j oud met AML die een indicatie voor allo-hct hebben ( met UCB) |
| Eligibility | WT1 positivity of the AML |
| Status | open |
| Participants | Prinses Maxima Centrum (c.a.lindemans@prinsesmaximacentrum.nl), UMC Utrecht (l.e.vanderwagen@umcutrecht.nl) |
| Reference | Https://www.onderzoekmetmensen.nl/nl/trial/55718 |