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

Phase 1

• Conditions: B-cell Acute Lymphoblastic Leukemia
• Interventions: Biological: CD19-CAR-T Cells

• Registration Number: NCT03574168
• Lead Sponsor: Bioceltech Therapeutics, Ltd.

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.

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-20
• Last Update Submitted: 2018-06-20
• Study First Posted: 2018-06-29
• Last Update Posted: 2018-06-29
• Study Start: 2018-07-20
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Objective Response Rate, ORR	Up to Day90 after the CD19-CAR-T cell infusion	The percentage of participants who achieved complete remission (CR) over all participants (CRR).; The percentage of participants who achieved partial remission (PR) over all participants (PRR).

Secondary Outcome Measures

Name	Time	Method
The amount of CAR-T cells remaining in vivo	2 years after cell infusion.	Measure and analyze monthly
The lifetime of CAR-T cells remaining in vivo	2 years after cell infusion.	Measure and analyze monthly

Trial Locations

Locations (1)

Hebei Yanda Ludaopei Hospital; 🇨🇳 Langfang, Hebei, China