Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy
NCT05640713 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2022-12-07
Summary
This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy in china.
Conditions
- Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited
Interventions
- DRUG
-
ThisCART19A
ThisCART19A is a new type CAR-T therapy for patients with r/r B Cell Malignancy .
- DRUG
-
Fludarabine Pill
Fludarabine is used for lymphodepletion.
- DRUG
-
Cyclophosphamide is used for lymphodepletion.
- DRUG
-
VP-16 Protocol
VP-16 is used for lymphodepletion.
Sponsors & Collaborators
-
Fundamenta Therapeutics, Ltd.
collaborator INDUSTRY -
Henan Cancer Hospital
lead OTHER_GOV
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
- 2022-12-01
- Primary Completion
- 2025-02-01
- Completion
- 2025-08-01
Countries
- China
Study Locations
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