A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL
NCT ID: NCT04532268
Last Updated: 2020-08-31
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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RECRUITING
EARLY_PHASE1
72 participants
INTERVENTIONAL
2020-08-23
2026-08-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of Humanized CD19 CAR T-cells
Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
Humanized CD19 CAR-T cells
Each subject receive humanized CD19 CAR T-cells by intravenous infusion
Interventions
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Humanized CD19 CAR-T cells
Each subject receive humanized CD19 CAR T-cells by intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
1. CR not achieved after standardized chemotherapy;
2. CR achieved following the first induction, but CR duration is less than 12 months;
3. Ineffectively after first or multiple remedial treatments;
4. 2 or more relapses;
4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \>5% (by morphology), and/or \>1% (by flow cytometry);
5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
1. Male or female aged 18-75 years;
2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
3. Relapsed or refractory B-NHL (meeting one of the following conditions):
1. No response or relapse after second-line or above chemotherapy regimens;
2. Primary drug resistance;
3. Relapse after auto-HSCT;
4. At least one assessable tumor lesion per Lugano 2014 criteria;
1. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
3. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
4. Estimated survival time ≥ 3 months;
5. ECOG performance status 0 to 2;
6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion Criteria
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
8. Creatinine \>2.5mg/dl, or ALT / AST\>3 times of normal amounts, or bilirubin\>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
3 Years
75 Years
ALL
No
Sponsors
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Yake Biotechnology Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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He Huang
Clinical Professor
Locations
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The First Affiliated Hospital，College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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He Huang, PhD
Role: primary
References
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Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.
Song F, Hu Y, Zhang Y, Zhang M, Yang T, Wu W, Huang S, Xu H, Chang AH, Huang H, Wei G. Safety and efficacy of autologous and allogeneic humanized CD19-targeted CAR-T cell therapy for patients with relapsed/refractory B-ALL. J Immunother Cancer. 2023 Feb;11(2):e005701. doi: 10.1136/jitc-2022-005701.
Other Identifiers
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hCD19-001
Identifier Type: -
Identifier Source: org_study_id