Study of Anti-CD22 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma

NCT03692767 | Unknown Early Phase 1

• 1 other identifier: CD22 CAR NK-BJZL-01
• Study Type: interventional
• Target: 9
• 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 CD22 CAR 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

  Day 3-Year 2 after injection

Study Arms (1)

Anti-CD22 CAR NK cells

EXPERIMENTAL

Total dose of 50-600 thousand /kg Anti-CD22 CAR NK cells will be administered at day0

Biological: Anti-CD22 CAR NK Cells

Interventions

Anti-CD22 CAR NK Cells BIOLOGICAL

Anti-CD22 CAR NK Cells injection

Anti-CD22 CAR 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 extra-medullary 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 × ULN (Gilbert Syndrome \> 3 × ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3 × ULN Serum creatinine clearance \>60 mL/min
• Serological examination:
• Absolute neutrophil count (ANC) \<0.75×109/L Platelet count (PLT) \<50×109/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);
• Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation
• Creatinine \> 1.5 times normal upper limit or ALT / AST \> 3 times normal upper limit or bilirubin \> 2 times normal upper limit
• New York Heart Association (NYHA) graded above or above

Sponsors & Collaborators

• Allife Medical Science and Technology Co., Ltd.: lead

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
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: March 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: January 30, 2019

Record last verified: 2018-09