Non-Hodgkin's Lymphoma Clinical Trial
Official title:
A Multicenter, Open Phase I Study to Evaluate the Safety and Pharmacokinetic Profile of F01 in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
This is a multicenter, open, Phase I clinical study to evaluate the safety and tolerability of F01 in subjects with relapsed/refractory non-Hodgkin lymphoma, and to determine MTD and/or RD.
Approximately 55 participants with relapsed and/or refractory large B-cell lymphoma and follicular lymphoma stage 3b are planned to enroll. This study is divided into two stages: dose escalation and dose extension. In the phase of dose escalation, a single dose escalation study will be carried out first, and then multiple dose escalation studies will be carried out. In the dose expansion phase, up to 3 subjects who had previously received CD19-targeted CAR T cell therapy may enroll. After the completion of the single dose escalation study, SRC will determine the MTD and/or RD of the single dose escalation phase based on the safety, pharmacokinetic profile (if applicable), immunogenicity, efficacy, and other data available at the time for each dose group. SRC will also determine whether the study will continue with multiple dose escalation studies or a single dose is sufficient to meet therapeutic needs. Multiple dose escalation can be skipped to provide recommendations for dose expansion phase studies based directly on single dose MTD and/or RD doses. After fully evaluating all opinions and data, the sponsor may choose to: 1) Multiple dose escalation studies are not conducted, and the MTD and/or RD doses with a single dose increase are directly entered into the dose expansion phase. In this case, enrolled subjects are continued to receive a single dose during the dose expansion phase to further confirm the safety and efficacy of subjects under RD dose; 2) After the single dose increment, enter the multi-dose increment study, and enter the dose extension phase after confirming the MTD and/or RD doses of multiple doses. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Completed |
NCT01878890 -
Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.
|
Phase 1 | |
| Completed |
NCT04152148 -
A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients
|
Phase 1 | |
| Recruiting |
NCT05096234 -
18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma
|
Phase 2 | |
| Recruiting |
NCT05191225 -
Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study
|
Phase 4 | |
| Recruiting |
NCT05623982 -
Phase Ib/II Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03664635 -
MB-CART20.1 Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02356159 -
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
|
Phase 1/Phase 2 | |
| Terminated |
NCT01699581 -
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
|
Phase 2 | |
| Completed |
NCT01763398 -
Analysis of the Risk Factors for the Neutropenic Fever in the High Risk NHL Patients for Developing Febrile Neutropenia Who Received 3-weekly CHOP-like Chemotherapy With Primary G-CSF Prophylaxis; Prospective Multicenter Observation Study
|
N/A | |
| Completed |
NCT01205503 -
Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release
|
Phase 2 | |
| Completed |
NCT00969462 -
Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma
|
Phase 4 | |
| Completed |
NCT00975975 -
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
|
Phase 2 | |
| Completed |
NCT00659425 -
CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00608907 -
An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)
|
Phase 1 | |
| Withdrawn |
NCT00577161 -
Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
|
Phase 3 | |
| Terminated |
NCT00475332 -
Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar
|
Phase 2 | |
| Completed |
NCT00533728 -
Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00430352 -
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
|
Phase 4 | |
| Completed |
NCT00581646 -
Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
|
N/A |