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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05640713 on ClinicalTrials.gov