Study of Anti-CD19 iCAR NK Cells in Relapsed and Refractory B Cell Lymphoma

NCT03824951 | Unknown Early Phase 1

• 1 other identifier: CD19 iCAR NK-BJZL-01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD19 iCAR NK cells in patients with relapsed refractory B cell lymphoma.

Conditions

Refractory B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Occurrence of treatment related adverse events as assessed by CTCAE v4.0

  Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.

  1 year

Study Arms (1)

Anti-CD19 iCAR NK Cells

EXPERIMENTAL

Biological: Anti-CD19 iCAR NK Cells

Interventions

Anti-CD19 iCAR NK Cells BIOLOGICAL

Anti-CD19 iCAR NK Cells injection

Anti-CD19 iCAR NK Cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry
• Previously accepted ≥ first-line regimen chemotherapy
• Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation
• Over 18 years old and under 70 years old
• The expected survival period is more than 3 months.
• ECOG≤2
• Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine clearance ≥40 mL/min; ALT and AST≤3 times normal range, Total bilirubin ≤ 2.0 mg / dL;
• Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L;
• The pregnancy test for women of childbearing age must be negative; both men and women must agree to use effective contraception during the treatment period and for the following 1 year.
• Measurable target lesion

You may not qualify if:

• Patients with extramedullary relapse
• Burkitt's lymphoma/leukemia
• Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment;
• Liver and kidney function:
• Total bilirubin \> 2 x ULN (Gilbert Syndrome \> 3 x ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3 × ULN
• Serum creatinine clearance \>60 mL/min
• Serological examination:
• Absolute neutrophil count (ANC) \<0.75x109/L
• Platelet count (PLT) \<50x109/L
• Active hepatitis B (HBV-DNA \> 1000 copies / mL), hepatitis C, or uncontrolled infection
• GVHD ≥ 2 or anti-GVHD treatment
• IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion;
• Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks
• Active CNS disease (tumor cells in CSF, but \< 5 WBCs/mL can be included);

Sponsors & Collaborators

• Allife Medical Science and Technology Co., Ltd.: lead
• Peking University Cancer Hospital & Institute: collaborator

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: January 31, 2019
• Study Start: February 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: January 31, 2019

Record last verified: 2019-01