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ThisCART19A for B-NHL Relapsed After Auto-CAR T

NCT05691153 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-01-19

No results posted yet for this study

Summary

This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A (allogeneic CAR-T targeting CD19) in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma.

Conditions

  • CAR
  • B Cell Lymphoma
  • Relapsed Non-Hodgkin Lymphoma

Interventions

DRUG

ThisCART19A with Dose Level 1

ThisCART19A，2×10\^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）, after the lymphodepletion conditioning of fludarabine, CTX and VP-16

DRUG

ThisCART19A with Dose Level 2

ThisCART19A，3×10\^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）, after the lymphodepletion conditioning of fludarabine, CTX and VP-16

Sponsors & Collaborators

  • Fundamenta Therapeutics, Ltd.

    collaborator INDUSTRY

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
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
2025-11-30
Completion
2025-11-30

Countries

  • China

Study Locations

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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 NCT05691153 on ClinicalTrials.gov