Study on bbT369 for Treating Difficult or Returning B Cell Non-Hodgkin's Lymphoma

Sponsor: 2seventy bio

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05169489

Provider View

This clinical trial is testing a new treatment called bbT369, which is a specially modified cell therapy, to see if it is safe and effective for patients with B cell Non-Hodgkin's Lymphoma that has not responded to previous treatments or has come back.

Patient Parameters

Program Overview

This study is exploring a new treatment called bbT369, which is a type of CAR T cell therapy with a special gene edit, to see if it can help patients with B cell Non-Hodgkin's Lymphoma (NHL) that has returned or not responded to other treatments. The study is divided into two phases: Phase 1 will test different doses to find the safest and most effective amount, while Phase 2 will further evaluate the treatment in two groups of patients—those who have had CAR T therapy before and those who have not. Participants will be monitored for up to 15 years to check for safety and long-term effects.

Description

This clinical trial is a first-in-human study to evaluate the safety and effectiveness of a new treatment called bbT369 for patients with B cell Non-Hodgkin's Lymphoma (NHL) that has returned or not responded to other treatments. The study is being conducted at multiple sites and is open to adults aged 18 and older.

In Phase 1, researchers will test different doses of bbT369 to find the safest and most effective amount. Once the best dose is determined, Phase 2 will begin, enrolling patients into two groups: those who have previously received CAR T cell therapy and those who have not. The study will follow participants for up to 15 years to monitor for safety and long-term effects of the treatment.

Participants will need to meet certain criteria to join the study, including having a specific type of B cell NHL and having tried other treatments without success. The study aims to provide new insights into whether bbT369 can offer a new treatment option for patients with this challenging condition.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a performance status score of 2 or less, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a diagnosis of specific types of B cell Non-Hodgkin's Lymphoma, such as Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL).
  • Have relapsed or refractory B cell NHL after a stem cell transplant or at least two previous treatments, including specific chemotherapy and antibody treatments.
  • Have at least one tumor that can be detected by a specific type of scan at the time of enrollment.

Exclusion Criteria

  • Have received any investigational cell therapy before joining the study, unless approved by the study sponsor.
  • Have disease progression within six weeks of previous anti-CD19 CAR T cell therapy.
  • Have unresolved side effects or organ damage from previous treatments that could pose a risk.
  • Have had severe side effects from previous CAR T therapy that could increase risk with bbT369.
  • Have primary central nervous system lymphoma or significant brain-related conditions.
  • Have an active autoimmune disease requiring certain treatments in the past two years.
  • Have received prior anti-CD79a therapy.
  • Have had an allogeneic bone marrow transplant (a transplant from a donor). Autologous stem cell transplants (using the patient's own cells) are allowed.

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