Clinical Trials Logo
  1. Home
  2. Non-Hodgkin's Lymphoma
  3. NCT04152148

A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients

Non-Hodgkin's Lymphoma Clinical Trial

Official title:
A Phase I Clinical Trial of BAT4306F (for Injection) on Safety, Tolerability and Pharmacokinetics for Patients With CD20-positive, B-cell Non-Hodgkin's Lymphoma

Clinical Trial Summary

The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in patients with CD20-positive B-cell lymphoma

Clinical Trial Description

1. The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in patients with CD20-positive B-cell lymphoma, when the injection dosage escalates, to ultimately determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and recommended dosage for phase II clinical studies ( RP2D); 2. To evaluate the pharmacokinetics (PK) of BAT4306F(for injection); 3. To evaluate the immunogenicity profile of BAT4306F(for injection); 4. To evaluate the efficacy profile of BAT4306F (for injection);Using the Lugano criteria (2014), the 2008 IWCLL efficacy evaluation criteria, and the 2014 IWWM-7 efficacy evaluation criteria were used to evaluate the efficacy of related diseases at week 7, week 13, and week 19. The index of evaluation was ORR (including CR, PR, SD and PD, ORR is the proportion of patients with CR and PR). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04152148
Study type Interventional
Source Bio-Thera Solutions
Contact
Status Completed
Phase Phase 1
Start date September 4, 2018
Completion date January 13, 2021
View Details
See also
  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
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 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 NCT00969462 - Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma Phase 4
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
Terminated NCT00475332 - Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar Phase 2
Withdrawn NCT00577161 - Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL Phase 3
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
Completed NCT00150462 - Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies Phase 1