Clinical trial NCT03574168: CD19-CAR-T Cells in Patients With R/R B-ALL
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: B-cell Acute Lymphoblastic Leukemia
Lead sponsor: Bioceltech Therapeutics, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-29
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Obtain Informed Consent Form (ICF) voluntarily signed by the patient;
2. Age 3-70 years old;
3. Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;
4. B cells are positive for CD19 expression;
5. 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:

1. Patients with non-B cell acute leukemia;
2. 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
3. Active infection;
4. Human immunodeficiency virus (HIV) positive;
5. Acute and chronic graft-versus-host disease (GVHD)\> Level 1；
6. Pregnant or lactating women;
7. Patients do not agree to use effective contraception during the treatment period and following 3 months;
8. Patients who participated in other clinical studies at the same time;
9. 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;
10. Long-term use greater doses of hormones than physiological doses.

Primary outcomes:
measure: Objective Response Rate, ORR
timeFrame: Up to Day90 after the CD19-CAR-T cell infusion
Secondary outcomes:
measure: The amount of CAR-T cells remaining in vivo
timeFrame: 2 years after cell infusion.
measure: The lifetime of CAR-T cells remaining in vivo
timeFrame: 2 years after cell infusion.
Other outcomes:
Locations:
city: Langfang
country: China
facility: Hebei Yanda Ludaopei Hospital
state: Hebei
Study officials:
affiliation: Hebei Yanda Ludaopei Hospital
name: Peihua Lu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: