Trial | NCT03574168  Report issue

Title

CD19-CAR-T Cells in Patients With R/R B-ALL
Phase I Study of the Safety and Efficacy of CD19-CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Primary objective:

To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.

Secondary objective:

To Assess the patient's quality of life after receiving the treatment.
Study Started
Jul 20
2018
Anticipated
Primary Completion
Dec 31
2019
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Jun 29
2018

Biological CD19-CAR-T Cells

T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.

CD19-CAR-T Cells Experimental

Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.

Criteria 

Inclusion Criteria:

Obtain Informed Consent Form (ICF) voluntarily signed by the patient;
Age 3-70 years old;
Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;
B cells are positive for CD19 expression;
Peripheral blood tumor cell load <50%; 6. KPS score >50 points;

7. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.

Exclusion Criteria:

Patients with non-B cell acute leukemia;
Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities
Active infection;
Human immunodeficiency virus (HIV) positive;
Acute and chronic graft-versus-host disease (GVHD)> Level 1；
Pregnant or lactating women;
Patients do not agree to use effective contraception during the treatment period and following 3 months;
Patients who participated in other clinical studies at the same time;
The researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study;
Long-term use greater doses of hormones than physiological doses.
No Results Posted