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Depsipeptide

Dr Johann De Bono

To evaluate the safety and tolerability of extended treatment with depsipeptide in patients who have at least demonstrated stable disease on prior Gloucester-sponsored depsipeptide clinical trials, and in the opinion of their physician/ investigator might benefit from continued treatment with depsipeptide

A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of Depsipeptide (FK228) in Patients That Have Completed a Prior Clinical Study With Depsipeptide.

Royal Marsden NHS Foundation Trust

Immunomodulating Agents

Patients will receive 2 cycles of ex-vivo expanded allogeneic γδT cells treatments, at 14 days' intervals, each cycle has 2 infusions. Ex-vivo expanded γδT cells are transfused to patients in a dosage escalated manner (Dose escalation, 1×107, 3×107, 9×107 per kg of body weight).

Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδT cells from donors will be adoptively transfused.

Ex-vivo expanded allogeneic γδT cells

Dehui Zou, MD

Wei Liu, MD

Shuhua Yi, MD

Jianmin Zhang, PhD

This study aims to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells obtained from a blood-related donor of patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL) or peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.

This study is a single-center, non-randomized, open label, no control, prospective clinical trial to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells from a blood-related donor of NHL or PTCL patients(except for γδT lymphoma). This study will include the following sequential phases: sign informed consent, γδT cell pre-culture, screening and registration to the trial, apheresis, γδT cell preparation, pre-treatment for lymphodepleting chemotherapy (selectable plan), treatments and follow-ups. The study will evaluate the safety and efficacy of the ex-vivo expanded allogeneic γδT cells in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) or peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.

Allogeneic γδ T Cells Immunotherapy in r/r Non-Hodgkin's Lymphoma (NHL) or Peripheral T Cell Lymphomas (PTCL) Patients

The Safety and Efficacy Assessment of Ex-Vivo Expanded Allogeneic γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) and Peripheral T Cell Lymphomas (PTCL)

Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

The incidence of DLTs will be recorded and assessed.

MTD or clinical recommended dose will be recorded and evaluated.

ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification as determined by study investigators.

DCR is defined as the incidence of either a CR, a partial response (PR) or stable disease (SD) per the Lugano Classification as determined by study investigators.

DOR is defined only for participants who experience an objective response after γδT cells infusion and is the time from the first objective response to disease progression or death from any cause.

PFS is defined as the time from the γδT cells infusion date to the date of disease progression or death from any cause.

OS is defined as the time from γδT cells infusion to the date of death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of Depsipeptide (FK228) in Patients That Have Completed a Prior Clinical Study With Depsipeptide.	NCT00299351	Peripheral T Ce...	Depsipeptide	0 Years -	Royal Marsden NHS Foundation Trust
Allogeneic γδ T Cells Immunotherapy in r/r Non-Hodgkin's Lymphoma (NHL) or Peripheral T Cell Lymphomas (PTCL) Patients	NCT04696705	Non-Hodgkin's L... Peripheral T Ce...	Ex-vivo expande...	18 Years -	Institute of Hematology & Blood Diseases Hospital, China

Spots Global Cancer Trial Database for peripheral t cell lymphoma (ptcl)