NCT04526834

Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma

Phase 1 Study of CD30-Directed Genetically Modified Autologous T-Cells (CD30.CAR-T) in Patients With Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Tessa Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma

Detailed description

Adult patients with relapsed or refractory CD30-positive Non-Hodgkin Lymphoma who have failed standard available therapies and who meet eligibility criteria will have blood drawn to manufacture the CD30.CAR-T cells. CD30.CAR-T cells will be infused once following the completion of lymphodepleting chemotherapy with Bendamustine and Fludarabine. Subjects will be closely monitored for DLT and safety.

Conditions

• Anaplastic Large Cell Lymphoma
• Peripheral T Cell Lymphoma
• Extranodal NK/T-cell Lymphoma
• Diffuse Large B Cell Lymphoma
• Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

Interventions

Type	Name	Description
DRUG	CD30.CAR-T	Bendamustine and Fludarabine (3 days) Dose level 1: 2 x 108 cell/m2 CD30.CAR-T (Day 0) Dose level 2: 4 x 108 cell/m2 CD30.CAR-T (Day 0) Dose level 3: 6 x 108 cell/m2 CD30.CAR-T (Day 0)

Timeline

• Start date: 2021-09-08
• Primary completion: 2022-11-22
• Completion: 2036-03-01
• First posted: 2020-08-26
• Last updated: 2023-04-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study