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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03574168
Other study ID # BT-ALL-001-v2
Secondary ID ChiCTR1800016541
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 20, 2018
Est. completion date December 31, 2019

Study information

Verified date June 2018
Source Bioceltech Therapeutics, Ltd.
Contact Zhongwei Xu, MD, Phd
Phone +86 010-69739722
Email willyxu001@bioceltech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 3 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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-? lentiviral vector, expanded in vitro for future administration.

Locations

Country Name City State
China Hebei Yanda Ludaopei Hospital Langfang Hebei

Sponsors (1)

Lead Sponsor Collaborator
Bioceltech Therapeutics, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate, ORR 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).
Up to Day90 after the CD19-CAR-T cell infusion
Secondary The amount of CAR-T cells remaining in vivo Measure and analyze monthly 2 years after cell infusion.
Secondary The lifetime of CAR-T cells remaining in vivo Measure and analyze monthly 2 years after cell infusion.
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