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)
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).
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. |
Country | Name | City | State |
---|---|---|---|
China | Hebei Yanda Ludaopei Hospital | Langfang | Hebei |
Lead Sponsor | Collaborator |
---|---|
Bioceltech Therapeutics, Ltd. |
China,
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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