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

B-cell Acute Lymphoblastic Leukemia Clinical Trial

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)

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
• 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
• 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.

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Burkitt Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

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.