Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunologic Factors

Three escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2，500 mg/m2, once a week for 4 doses;

Chimeric anti-CD20 monoclonal antibody

Yuan kai Shi, PhD

The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma

Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.

A Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SCT400, a Recombinant Chimeric Anti-CD20 Monoclonal Antibody，in Patients With CD20+ B-cell Non Hodgkin's Lymphoma.

Sinocelltech Ltd.

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Immunomodulating Agents

Three patients will be treated at the first \& each subsequent dose level. Patients will be observed for 30 days post T cell infusion. If there was one DLT in the first 3 patients, an additional 3 patients will be treated at that level. If no additional DLTs are observed (for a total of 1 DLT in 6 patients) then the dose will be escalated. If two patients in the first 3 patients at a dose level experience a DLT, the dose will be de-escalated to the previous level \& an additional 3 patients will be enrolled at that level if 6 have not yet been treated at that level. The maximum tolerated dose (MTD) is defined as the highest dose at which 0 or 1 patient in six has experienced a DLT. If 2 or 3 patients in the first 3 patients experience a DLT at the first dose level, the study will terminate.

Subjects will receive a single infusion of autologous bulk TIL 13831 TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 13831 TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4 + and CD8+ T Cells expressing the TIL 13831 TCR.

Subjects in Cohort 1 will receive 7.5 x 10\^6/kg TIL 1383I TCR transduced T cells.

Subjects in Cohort 2 will receive 2.5 x 10\^7/kg TIL 1383I TCR transduced T cells.

Subjects in Cohort 3 will receive 7.5 x 10\^7/kg TIL 1383I TCR transduced T cells.

Escalating Doses

Michael Nishimura, PhD

Ann Lau Clark, RN, MSN

Joseph Clark, MD

Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded investigator initiated therapy for patients with advanced melanoma.

This is a Phase 1 dose escalation study designed to find the highest dose of TIL 1383I TCR transduced T cells that can safely be given. Three cohorts of 3 patients will be treated with increasing doses of TIL 1383I TCR transduced T cells. Patients will be monitored clinically and immunologically for a year after infusion. Subjects in Cohort 1 will receive 7.5 X 10\^6/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 2 will receive 2.5 x 10\^7/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 3 will receive 7.5 x 10\^7/kg TIL 1383I TCR transduced T cells.

Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes

Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes: A Phase 1b Study

Establish a recommended phase II dose of autologous T cell receptor transduced T cells by evaluating unexpected Grade 2 adverse events through Grade 5 regardless of attribution, all toxicities attributed to the cells, and all incidences of intubation including the duration and reason for intubation.

Change in T cell count from baseline to 4 weeks.

Potential auditory changes from baseline to 4 weeks.

Potential visual changes from baseline to 4 weeks.

CT scan or physical examination will be used to evaluate for a clinical objective response in patients who have received transduced T Cells at scheduled time points.

National Cancer Institute (NCI)

Loyola University

Professor

Symptoms and General Pathology

Recurrence

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Acute Disease

Hematologic Diseases

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Acute Leukemia of Ambiguous Lineage

INA03 will be administered IV on Day 1, Day 14 of 28-day cycles. The administration of INA03 will begin at 0.02 mg/kg. Study Part I is a titration study to determine the dose for the first INA03 infusion. Patients will be enrolled in sequential cohorts of 2 patients to receive ascending starting doses of INA03, starting from the lowest starting dose (0.02 mg/kg), and followed by subsequent administrations of INA03 (D14 and beyond) at a fixed dose of 0.1 mg/kg. The starting dose will be increased every cohort of 2 patients until evidence of absence of marrow residual erythroblasts by D14 myelogram. This dose is referred to as the MEID and will be selected as the D1 dose for the study Part 2. Patient accumulation in Part I of the study will continue until no evidence of non-hematological DLT within 28 days post dosing

INA03 administration

Dominique Genre, Dr

Margot Berline, MSc, MBA

Dominique GENRE, MD

Norbert VEY

Christian RECHER

Norbert VEY, Pr

This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL.

The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.

Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia

A Phase I, First in Human, Open-label Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia

MEID defined as the lowest dose associated with the risks of residual erythroblasts in the bone marrow at 2 weeks from initial dosing or grade 2 or above non hematologic toxicity within 2 weeks from initial dosing

the maximum tolerated dose (MTD) for subsequent administrations (D15 from initial dosing and beyond)

Safety from the findings of reports of adverse events based on incidence, severity (as graded by the NCI-CTCAE v5.0), cumulative nature of treatment-emergent adverse event (TEAEs)

Peak Plasma Concentration (Cmax) will be calculated, as appropriate

Area under the plasma concentration versus time curve (AUC) will be calculated, as appropriate

The terminal half-life will be calculated, as appropriate

PD according to variation of erythroblast and blasts decrease using bone marrow as-pirate (BMA), and blood samples before and under treatment

Serum concentration of anti-INA03 antibodies in micrograms per milliliter

Clinical response as defined by European LeukemiaNet (ELN) 2017 recommendations

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.	NCT02206308	B-cell Non Hodg...	Chimeric anti-C...	18 Years - 75 Years	Sinocelltech Ltd.
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes	NCT02870244	Melanoma	Escalating Dose...	18 Years - 89 Years	Loyola University
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes	NCT02870244	Melanoma	Escalating Dose...	18 Years - 89 Years	Loyola University
Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.	NCT02206308	B-cell Non Hodg...	Chimeric anti-C...	18 Years - 75 Years	Sinocelltech Ltd.
Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia	NCT03957915	Acute Lymphobla... Acute Lymphobla... Acute Myeloid L... Acute Myeloid L... Mixed Phenotype...	INA03 administr...	18 Years -	Institut Paoli-Calmettes

Spots Global Cancer Trial Database for escalating doses