NCT05563545

Brief Summary

This study is a single arm clinical study to observe the safety ，dose tolerance and pharmacokinetic characteristics of CAR NK-CD19 in patients with recurrent or refractory CD19 positive acute lymphoblastic leukemia, and preliminarily evaluate the effectiveness, the immunogenicity of the product and the correlation between the changes of cytokines after infusion and CRS , ICANS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
Last Updated

November 28, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

September 26, 2022

Last Update Submit

November 24, 2022

Conditions

Acute Lymphoblastic Leukemia

Keywords

NKCD19 positiveAcute B lymphoblastic leukemia

Outcome Measures

Primary Outcomes (6)

  • Safety of CAR NK-CD19 Cell

    Incidence of adverse events associated with CAR NK-CD19 treatment, abnormal clinically significant laboratory findings, including dose-limiting toxicity (DLT) and maximum-tolerated Dose (MTD).

    Up to 3 months after cell infusion

  • Cell count of CAR NK-CD19

    CAR NK-CD19 cell count

    From 1 to 720 days after infusion

  • Cmax of CAR NK-CD19

    CAR gene copy number maximum (Cmax)

    From 1 to 720 days after infusion

  • Tmax of CAR NK-CD19

    Time to maximum (Tmax)

    From 1 to 720 days after infusion

  • AUC of CAR NK-CD19

    Area under curve (AUC)

    From 1 to 720 days after infusion

  • Other pharmacokinetic of CAR NK-CD19 Cell

    Other related pharmacokinetic parameters in peripheral blood and bone marrow

    From 1 to 720 days after infusion

Secondary Outcomes (3)

  • The overall response rate (ORR)

    Up to 3 months after cell infusion

  • Concentration of anti-drug antibody (ADA)

    From 14 to 720 days after infusion

  • The changes of cytokines

    Up to 3 months after cell infusion

Study Arms (1)

CAR-NK-CD19 Cells

EXPERIMENTAL

After preconditioning with chemotherapy, CAR-NK-CD19 Cells will be evaluated.

Biological: CAR-NK-CD19 Cells

Interventions

CAR-NK-CD19 CellsBIOLOGICAL

CAR-NK-CD19 Cells, 1-3×10\^7 /KG, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 25-30 mg/m2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 250-300 mg/m2 (D-5\~D-3), determined by tumor burden at baseline.

CAR-NK-CD19 Cells

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥12 years in the single-dose exploration phase, age ≥3 years in the dose exploration phase, both sexes;
  • Meet the diagnostic criteria for recurrent or refractory CD19 positive acute lymphoblastic leukemia.
  • The main organs have good organ function.
  • The estimated survival time is ≥12 weeks.
  • Blood pregnancy tests for women of childbearing age are negative.
  • The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form.

You may not qualify if:

  • Central nervous system involvement；
  • Simple extramedullary leukemia or simple extramedullary recurrence；
  • Received hematopoietic stem cell transplantation within the last 3 months and had graft-versus-host disease (GVHD) in the last 2 weeks, requiring immunosuppressive agents；
  • Treated with high-dose corticosteroids in the last 1 week；
  • Allogeneic cell therapy, major surgery, and live or attenuated vaccine had been received within 4 weeks prior to CAR NK-CD19 infusion；
  • Had received other antitumor therapy or had an uncontrolled infection within 2 weeks prior to CAR NK-CD19 infusion；
  • Systemic steroids were used within 3 days before CAR NK-CD19 infusion；
  • Toxicity caused by previous treatment do not fully recover or do not stabilize to grade 1；
  • Concomitant autoimmune diseases, central nervous system diseases, other active malignancies, infectious diseases, severe cardiovascular diseases, etc；
  • Known allergies to study drugs or drugs that may be used in the study；
  • Other conditions determined by Investigator which are not suitable for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Sanhe, Hebei, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 3, 2022

Study Start

July 21, 2022

Primary Completion

November 25, 2022

Study Completion

November 25, 2022

Last Updated

November 28, 2022

Record last verified: 2022-09

Locations

CN(1)