Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Phase 1/2a, Open-Label, Dose Escalation Trial of GEN3017 With Expansion Cohorts in Relapsed or Refractory CD30+ Classical Hodgkin Lymphoma and CD30+ Non-Hodgkin Lymphoma
The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of GEN3017 as a monotherapy in participants with relapsed or refractory (R/R) CD30-expressing lymphomas. GEN3017 will be administered via subcutaneous injections. All participants will receive active drug; no one will be given placebo.
This multicenter trial will be conducted in 2 parts: Dose Escalation (phase 1) and Expansion (phase 2a). The Dose Escalation Part (phase 1) of the trial will evaluate dose-limiting toxicities (DLTs) to determine the recommended phase 2 dose (RP2D), and if reached, the maximum tolerated dose (MTD) for R/R CD30+ classical Hodgkin lymphoma (cHL) and R/R CD30+ T-cell lymphoma (TCL), respectively. The Expansion Part (phase 2a) will evaluate the anti-tumor activity of GEN3017 at the RP2D and selected dosage(s) will be assessed together with safety, immunogenicity, pharmacokinetics, and pharmacodynamics in R/R CD30+ cHL participants (including adults; and adolescent and young adults) and in participants with selected R/R CD30+ TCL subtypes (adults only). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03755414 -
Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
|
Phase 1 | |
| Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
| Active, not recruiting |
NCT04082936 -
A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
| Completed |
NCT02543879 -
Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies
|
Phase 1 | |
| Completed |
NCT01939327 -
Safety and Efficacy of Revlimid® (Lenalidomide) With Mabthera® (Rituximab) in Non-Hodgkin's Lymphoma
|
Phase 2 | |
| Completed |
NCT00503451 -
A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00509379 -
Non-randomized Safety Study With Bortezomib/Rituximab in Relapsed/Refractory Indolent Lymphoma
|
Phase 2 | |
| Terminated |
NCT00383097 -
Lmp1 and Lmp2 Specific CTLs Following Cd45 Antibody for Relapsed Ebv-Positive Hodgkin's Or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT01010295 -
A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae
|
Phase 2 | |
| Completed |
NCT00992446 -
Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
|
Phase 2 | |
| Recruiting |
NCT05066958 -
Ex-vivo Primed Memory Donor Lymphocyte Infusion to Boost Anti-viral Immunity After T-cell Depleted HSCT
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05205512 -
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial
|
N/A | |
| Recruiting |
NCT05006716 -
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT03297424 -
A Study of PLX2853 in Advanced Malignancies.
|
Phase 1 | |
| Completed |
NCT02767388 -
Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery
|
||
| Active, not recruiting |
NCT03997968 -
A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT04136756 -
NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma
|
Phase 1 |