A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
NCT ID: NCT05444322
Last Updated: 2022-07-11
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
EARLY_PHASE1
18 participants
INTERVENTIONAL
2022-07-05
2025-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RD14-01 cell infusion
Infused i.v. in a single dose
RD14-01 cell infusion
Autologous CAR T cells
Interventions
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RD14-01 cell infusion
Autologous CAR T cells
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a).
3. ECOG: 0-1.
4. Life expectancy greater than 3 months.
5. Cardiac left ventricle ejection fraction ≥50%.
6. Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent.
Exclusion Criteria
2. Hepatitis B surface antigen (HBsAg) or hepatitis B e-antigen (HBeAg) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive; cytomegalovirus (CMV) DNA positive; Epstein-Barr virus (EBV) DNA positive.
3. Central nervous system (CNS) metastases.
4. Participated in other clinical studies within 4 weeks prior to screening.
5. History of alcoholism, drug abuse or mental illness.
6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
18 Years
75 Years
ALL
No
Sponsors
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He Huang
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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Other Identifiers
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BHCT-RD14-01
Identifier Type: -
Identifier Source: org_study_id
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