Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2018-07-20
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CD19-CAR-T Cells
Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
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-ζ lentiviral vector, expanded in vitro for future administration.
Interventions
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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-ζ lentiviral vector, expanded in vitro for future administration.
Eligibility Criteria
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Inclusion Criteria
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
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.
3 Years
70 Years
ALL
No
Sponsors
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Bioceltech Therapeutics, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Peihua Lu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hebei Yanda Ludaopei Hospital
Locations
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Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Peihua Lu, MD, PhD
Role: primary
Other Identifiers
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ChiCTR1800016541
Identifier Type: REGISTRY
Identifier Source: secondary_id
BT-ALL-001-v2
Identifier Type: -
Identifier Source: org_study_id