Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
NCT04526834 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2023-04-20
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
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
- 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)
Sponsors & Collaborators
-
Tessa Therapeutics
lead INDUSTRY
Principal Investigators
-
Sairah Ahmed · MD Anderson
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-08
- Primary Completion
- 2022-11-22
- Completion
- 2036-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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