NCT04782193

Brief Summary

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 23, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2.6 years

First QC Date

February 26, 2021

Last Update Submit

April 16, 2023

Conditions

B Cell Lymphoma

Keywords

CD19CD22CAR-T

Outcome Measures

Primary Outcomes (2)

  • Adverse events that related to treatment

    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

    2 years

  • The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B Cell Lymphoma

    The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline

    6 months

Secondary Outcomes (12)

  • Rate of prime CAR-T cells in bone marrow

    2 years

  • Rate of prime CAR-T cells in peripheral blood

    2 years

  • Quantity of prime CAR copies in bone marrow

    2 years

  • Quantity of prime CAR copies in peripheral blood

    2 years

  • Rate of CD19 and CD22 positive cells in Bone marrow

    1 years

  • +7 more secondary outcomes

Study Arms (1)

prime CAR- T cells

EXPERIMENTAL

Patients will be be treated with CD19 and CD22 prime CAR- T cells

Biological: CD19 and CD22 targeted prime CAR- T cells

Interventions

CD19 and CD22 targeted prime CAR- T cellsBIOLOGICAL

A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously

prime CAR- T cells

Eligibility Criteria

Age2 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent
  • Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:
  • Failed to standard chemotherapy regimens;
  • Relapse after complete remission, high-risk and / or refractory patients ;
  • Relapse after hematopoietic stem cell transplantation;
  • Evidence for cell membrane CD19 or CD22 expression
  • All genders ages: 2 to 75 years
  • The expect time of survive is above 3 months;
  • KPS\>60
  • No serious mental disorders ;
  • Left ventricular ejection fraction ≥50%
  • Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
  • Sufficient renal function defined by creatinine clearance≤2 x ULN;
  • Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
  • With single or venous blood collection standards, and no other cell collection contraindications;
  • +1 more criteria

You may not qualify if:

  • Previous history of other malignancy;
  • Presence of uncontrolled active infection;
  • Evidence of disorder that need the treatment by glucocorticoids;
  • Active or chronic GVHD
  • The patients treatment by inhibitor of T cell
  • Pregnant or breasting-feeding women;
  • Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

920th Hospital of Joint Logistics Support Force

Kunming, Yunnnan, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Antigens, CD19

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antigens, CDAntigens, DifferentiationAntigens, SurfaceAntigensBiological FactorsAntigens, Differentiation, B-LymphocyteMinor Histocompatibility AntigensHistocompatibility AntigensIsoantigensBiomarkers

Study Officials

  • Sanbin Wang, MD

    920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    PRINCIPAL INVESTIGATOR

  • Cheng Qian, PhD

    Chongqing University Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Yang, PhD

CONTACT

86-13206140093yangzhi@precision-biotech.com

Sanbin Wang, MD

CONTACT

Sanbin1011@163.com

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

February 26, 2021

First Posted

March 4, 2021

Study Start

May 23, 2021

Primary Completion

December 31, 2023

Study Completion

July 1, 2024

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

CN(1)