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:
Cohort 1: R/R DLBCL of Folliculair lymfoom gr 3b after 2 lines systemic therapy or after 1 line systemic therapy in transplant-ineligible patients
Cohort 2: Folliculair lymfoom gr 1-3a and marginale zone lymfoom after 2 of more lines systemic therapy (opens no earlier than 2025)

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);
Part 2 (expansion): To evaluate the objective tumor response rate (ORR).

Study docs

In- and exclusion criteria

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
For all indications at least 2 prior therapies. Exception: PCNSL can be included after 1 previous therapy. 

Study Docs

In- en exclusiecriteria
Advertentie text (approved by EC)

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

In- en exclusiecriteria

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)
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.

Study Docs

In and exclusion criteria
Physician fact sheet

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.nlhematol@amsterdamumc.nl)
UMCU (r.mous@umcutrecht.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)
Will be opened at: Universitair Medisch Centrum Groningen,  Maastricht University Medical Center 

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

 

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