LLPC Associated studies
Open studies
| Short name | CD19/CD20 biCAR |
| Study title | 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 soon |
| Medication | JNJ-90014496 Autologous CD19/CD20 Bi-specific CAR-T |
| Population |
2 cohorts: |
| Study docs | In- and exclusion criteria |
| Short name | Magnaz |
| Study title | 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 |
| Medication | Rituximab (4 x) as standard treatment, combined with 6 to 12 mnd zanubrutinib |
| Population | patients with IgM MGIS and anti MAG polyneuropathy |
| Study docs | In- and exclusion criteria |
| Short name | CA1231000 |
| Study title | 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) |
| Medication | BMS-986458; BCl6 degrader |
| Population | relapsed/refractory DLBCL and FL |
| study docs | In- and exclusion criteria |
| Short name | KT-US-499-0150 |
| Study title | 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) |
| Medication | KITE-363; Autologous anti-CD19/CD20 chimeric antigen receptor [CAR] T-cell product |
| Population | Relapsed and/or Refractory B-cell Lymphoma |
| Study info | Study information |
| Study docs | In- and exclusion criteria |
| Short name | BYON4228 |
| Study title | 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, location VUMC (m.chamuleau@amsterdamumc.nl) and Nijmegen (wendy.stevens@radboudumc.nl) |
| Medication | SIRPa inhibitor |
| Population | 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); |
| Study docs |
| Short name | M22-132 |
| Study title | 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) |
| Medication | Epcoritamab (bispecific CD3xC20 antibody) |
| Population | 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 |
| Study docs | In- and exclusion criteria |
| Short name | NX-5948-301 |
| Study title |
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) and RadboudUMC (W. Stevens) and UMCU (Utrecht) (R.Mous) |
| Medication | BTK-degrader (oral) |
| Population |
R/R CLL/SLL; DLBCL; tFL; Richter; high-grade B-cell lymphoma; FL; MCL; MZL; MW; PCNSL |
| Study Docs |
|
Short name |
GCT3014-01 |
| Study title | 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) |
| Medication | HexaBody®-CD38 |
| Population | Relapsed or refractory DLBCL, both de novo or histologically transformed and RRMM patients |
| Study Docs |
| Short name | DALY 2-EU |
| Study title | 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 |
| Medication | anti-CD19/CD20 CAR-T product MB-CART2019.1 |
| Population |
relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL) |
| Study Docs |
| Short name | Atalanta-1 (CP0201-NHL Cellpoint) |
| Study title | 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 | Activated in Amsterdam UMC (location AMC), LUMC |
| Medication | anti-CD19 CAR-T product 19CP02 |
| Population | Relapsed/refractory B-cell non-Hodgkin lymphoma (DLBCL, FL, MZL, MCL) |
| Study docs | In and exclusion criteria |
| Short name | EPCORE NHL-2 |
| Study title |
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma |
| Status | Open |
| Participants |
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) |
| Study info |
The study is open for arm 9 epcoritamab plus lenalidomide in rrFL POD24 |
| Study docs | Subject Eligibility |
| Short name | R/R CLL (GCT3013-03) |
| Study title | Phase 1b/2 GEN3013 Monotherapy Study Design |
| Study drug | Epcoritamab (subcutaneous CD3xCD20) |
| Population | Relapsed Refractory CLL and Richter |
| Participants |
Currently open in: Amsterdam UMC, AMC (a.p.kater@amsterdamumc.nl) & UMC Utrecht (R.Mous@umcutrecht.nl) |
| Study 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). |
| Study docs | In- and exclusion criteria |
Closed Studies
| EPCORE NHL-2 |
| ZUMA-2 cohort |
| GEN3009 |
| Valentine study |
| Lym1002 |
| EDO-S101-1001 |
| TRANSCEND WORLD (Celgene JCAR017-BCM-001) |
| CDK9 |
| ACT15320 |
| BELINDA (CCTL019H2301) |
| TRANSFORM (Celgene JCAR017-BCM-003 |
| Harbour |