B-cell Acute Lymphoblastic Leukemia
Conditions
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.
Interventions
BIOLOGICALCD19-CAR-T Cells
T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
Sponsors
Bioceltech Therapeutics, Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactZhongwei Xu, MD, Phd
Outcome results
None listed