CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

T

Tianjin Mycure Medical Technology

Status and phase

Unknown
Phase 1

Conditions

B-cell Acute Lymphoblastic Leukemia

Treatments

Biological: CD19 CAR-T cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT03671460
TianjinMycure-LDP-CD19 CAR-T

Details and patient eligibility

About

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

Full description

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.

Enrollment

18 estimated patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. More than 1 year;
  2. CD19 positive B-cell acute lymphoblastic leukemia;
  3. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.
  4. Expected to survive for more than 3 months;
  5. Informed consent is signed by a subject or his lineal relation.

Exclusion criteria

  1. Recent or current use of glucocorticoid or other immunosuppressor;
  2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
  3. Has a graft-versus-host response and requires the use of immunosuppressants;
  4. Drug uncontrollable central nervous system leukemia;
  5. Pregnant or lactating female;
  6. The patient did not agree to use effective contraception during the treatment period and for the following 1 year;
  7. A history of other malignant tumors;
  8. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

CD19-CAR-T Cells
Experimental group
Description:
Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
Treatment:
Biological: CD19 CAR-T cells

Trial contacts and locations

1

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Central trial contact

Chaoting Zhang, PhD

Data sourced from clinicaltrials.gov

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