CD19-CAR-T Cells in Patients With R/R B-ALL

Bioceltech Therapeutics

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

NCT03574168

BT-ALL-001-v2

ChiCTR1800016541 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 70 years old

Volunteers: No Healthy Volunteers

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;

6. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 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