LLPC geassocieerde studies
Open studies
| Naam | CD19/CD20 biCAR |
| Titel | Phase 1b Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma |
| Status | Open in UMCU, EMC volgt |
| Medicatie | JNJ-90014496 Autologous CD19/CD20 Bi-specific CAR-T |
| Populatie |
2 cohorten: |
| Study docs | In- and exclusion criteria |
| Naam | Magnaz |
| Titel | A multi-center, open-label, phase II study involving Zanubrutinib is being studied in combination with standard treatment (Rituximab or similar) in patients with MGUS (monoclonal gammopathy of unknown significance) in combination with anti-MAG (Myelin Associated Gycoprotein) neuropathy – MAGNAZ study |
| Status | Open in UMCU |
| Medicatie | Rituximab (4 maal) als standaardbehandeling, gecombineerd met 6 tot 12 mnd zanubrutinib |
| Populatie | patienten met IgM MGIS en anti MAG polyneuropathie |
| Study docs | In- and exclusion criteria |
| Naam | CA1231000 |
| Titel | A Phase 1/2, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination with Anti-lymphoma Agents in Participants with Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL) |
| Status | Open in MUMC (marjolein.vander.poel@mumc.nl) and in UMCG (m.nijland@umcg.nl) |
| Medicatie | BMS-986458; BCl6 degrader |
| Populatie | relapsed/refractory DLBCL and FL |
| Study docs | In- en exclusiecriteria |
| Naam | KT-US-499-0150 |
| Titel | A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma |
| Status | Open in Amsterdam UMC, location VUMC (m.j.kersten@amsterdamumc.nl, ilse.kuipers@amsterdamumc.nl, hemat.trial@amsterdamumc.nl) |
| Medicatie | KITE-363; Autologous anti-CD19/CD20 chimeric antigen receptor [CAR] T-cell product |
| Populatie | Relapsed and/or Refractory B-cell Lymphoma |
| Study info | Study informatie |
| Documenten | In- en exclusie criteria |
| Naam | BYON4228 |
| Titel | A first-in-human dose escalation and expansion study with the SIRPα-directed monoclonal antibody BYON4228 alone and in combination with rituximab to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy in patients with relapsed/refractory CD20 positive B-cell Non-Hodgkin’s Lymphoma (NHL) |
| Status | Open in Amsterdam UMC, locatie VUMC (m.chamuleau@amsterdamumc.nl) and Nijmegen (wendy.stevens@radboudumc.nl) |
| Medicatie | SIRPa inhibitor |
| Populatie | relapsed/refractory CD20 positive B-cell Non-Hodgkin’s Lymphoma (NHL) |
| Study info |
Part 1 (dose escalation): To evaluate the safety of BYON4228 alone and in combination with rituximab to determine the maximum tolerated dose (MTD), or optimal biological dose (OBD) if the MTD is not reached, and recommended combination dose regimen for expansion (RDE); |
| Documenten |
| Naam | M22-132 |
| Titel | Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma |
| Status | Open in Amsterdam UMC, locatie VUMC (m.chamuleau@amsterdamumc.nl), Groningen (m.nijland@umcg.nl), Maastricht (marjolein.vander.poel@mumc.nl) Leiden (j.s.p.vermaat@lumc.nl), Rotterdam (p.mutsaers@erasmusmc.nl) |
| Medicatie | Epcoritamab (bispecific CD3xC20 antibody) |
| Populatie | relapsed/refractory CD20 positive B-cell Non-Hodgkin’s Lymphoma (DLCBL, FL and MCL) |
| Study info | Epcoritamab in Combination with Arm 1: Lenalidomide for R/R DLBCL Arm 2: Ibrutinib and lenalidomide for R/R DLBCL (post-CAR-T) Arm 3: Polatuzumab, rituximab, cyclophosphamide, doxorubicin HCl, and prednisone (pola-R-CHP) for treatment-naïve DLBCL Arm 4: CC-99282 for R/R DLBCL Arm 5: CC-99282 for R/R FL Arm 6: 6A: Ibrutinib; 6B: Ibrutinib and venetoclax for R/R MCL Arm 7: Ibrutinib and venetoclax for treatment-naïve MCL NB arm 3 and 7 not open in the Netherlands |
| Documenten | In- en exclusiecriteria |
| Naam | NX-5948-301 |
| Titel |
A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton’s Tyrosine Kinase (BTK) Degrader, in Adults with Relapsed/Refractory B-cell Malignancies |
| Status | open in ErasmusMC (j.doorduijn@erasmusmc.nl) en RadboudUMC (W. Stevens) en UMCU (Utrecht) (R.Mous) |
| Medicatie | BTK-degrader (oral) |
| Populatie |
R/R CLL/SLL; DLBCL; tFL; Richter; high-grade B-cell lymphoma; FL; MCL; MZL; MW; PCNSL. |
| Documenten |
In- en exclusiecriteria |
| Naam | GCT3014-01 |
| Titel | An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies (DLBCL and AML) |
| Status | open in UMCU (m.jak@umcutrecht.nl) ,EMC (a.broyl@erasmusmc.nl) en MUMC (janine.van.elssen@mumc.nl) |
| Medicatie | HexaBody®-CD38 |
| Populatie | Relapsed or refractory DLBCL, both de novo or histologically transformed and RRMM patients |
| Documenten | In- en exclusiecriteria |
| Naam | DALY 2-EU |
| Titel | A pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL), who are not eligible for high-dose chemotherapy and autologous stem cell transplantation |
| Status |
open in UMCG, Amsterdam UMC (location AMC), ErasmusMC, LUMC |
| Medicatie | anti-CD19/CD20 CAR-T product MB-CART2019.1 |
| Populatie | relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL) Optional for SOC group: Cross-over to MB-CART2019.1 treatment (3rd line) at relapse or progression at any time within 1 year after randomization or Failure to achieve PR or CR at or beyond Week 8 after randomisation (4 cycles of R-GemOx or 3 cycles of BR plus polatuzumab vedotin) and the start of a new anti-lymphoma therapy is warranted. |
| Documenten | In en exclusiecriteria Physician fact sheet |
| Naam | Atalanta-1 (CP0201-NHL CellPoint) |
| Titel | A phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured 19CP02 in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma |
| Status | Open in Amsterdam UMC (location AMC), LUMC |
| Medicatie | anti CD19 CAR-T product 19CP02 |
| Populatie | Relapsed/refractory B-cell non-Hodgkin lymphoma (DLBCL, FL, MZL, MCL) |
| Documenten | In en exclusiecriteria |
| Naam | EPCORE NHL-2 |
| Titel |
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; |
| Status | Open |
| Deelnemers |
The study is open at Erasmus MC (p.lugtenburg@erasmusmc.nl; p.mutsaers@erasmusmc.nl; RNhema.ctc@erasmusmc.nl); UMCG (m.nijland@umcg.nl) LUMC (j.s.p.vermaat@lumc.nl); MUMC (marjolein.vander.poel@mumc.nl); VUMC (m.chamuleau@amsterdamumc.nl; hematol@amsterdamumc.nl), |
| Studie info |
The study is open for arm 9 epcoritamab plus lenalidomide in rrFL POD24 |
| Documenten | Subject Eligibility |
| Naam | R/R CLL (GCT3013-03) |
| Studie title | Phase 1b/2 GEN3013 Monotherapy Study De |
| Studie drug | Epcoritamab (subcutaneous CD3xCD20 |
| Populatie | Relapsed Refractory CLL en richter |
| Deelnemers |
Currently open in: Amsterdam UMC, AMC (a.p.kater@amsterdamumc.nl) & UMC Utrecht (R.Mous@umcutrecht.nl) |
| Studie info | R/R CLL after receiving at least 2 prior lines of systemic antineoplastic therapy, including treatment with (or intolerance of) a BTK inhibitor and with active CLL disease that needs treatment per iwCLL2018. Also for Richter's Syndrome (please see in- and exclusion criteria) |
| Studie docs | In- and exclusion criteria |
Gesloten Studies
| EPCORE NHL-2 |
| ZUMA-2 cohort 3 |
| GEN3009 |
| Valentine study |
| Lym1002 |
| EDO-S101-1001 |
| TRANSCEND WORLD (Celgene JCAR017-BCM-001) |
| CDK9 |
| ACT15320 |
| BELINDA (CCTL019H2301) |
| TRANSFORM (Celgene JCAR017-BCM-003) |
| Harbour |