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CRISPR (HPK1) Edited CD19-specific CAR-T Cells (XYF19 CAR-T Cells) for CD19+ Leukemia or Lymphoma.

NCT04037566 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-07-30

No results posted yet for this study

Summary

This is a first-in-human trial proposed to test CD19-specific CAR-T cells with edited endogenous HPK1 (XYF19 CAR-T cells) in patients with relapsed or refractory CD19+ leukemia or lymphoma. This is an investigational study designed as a single-center, open-label and single-arm clinical trial.

Conditions

  • Leukemia Lymphocytic Acute (ALL) in Relapse
  • Leukemia Lymphocytic Acute (All) Refractory
  • Lymphoma, B-Cell
  • CD19 Positive

Interventions

GENETIC

XYF19 CAR-T cell

Autologous T cells engineered to specify CD19 transduced with a lentiviral vector and electroporated with CRISPR guide RNA to disrupt expression of endogenous HPK1 administered by IV injection.

DRUG

Cyclophosphamide

A cytotoxic chemotherapy agent used for lymphodepletion prior to XYF19 CAR-T cells.

DRUG

Fludarabine

A chemotherapy agent used for lymphodepletion prior to XYF19 CAR-T cells.

Sponsors & Collaborators

  • Xi'An Yufan Biotechnology Co.,Ltd

    collaborator UNKNOWN

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Guangxun GAO, Dr. · Xijing Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2021-08-31
Completion
2024-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04037566 on ClinicalTrials.gov