NCT03398967

Brief Summary

CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells. Dual Specificity CD19 and CD20 or CD22 CAR-T cells can recognize and kill the CD19 negative malignant cells through recognition of CD20 or CD22. This is a phase 1/2 study designed to determine the safety of the allogenic gene-edited dual specificity CD19 and CD20 or CD22 CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory hematological malignancies.

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
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2018

Longer than P75 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

Study Start

First participant enrolled

January 2, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

4.4 years

First QC Date

January 8, 2018

Last Update Submit

January 8, 2018

Conditions

B Cell LeukemiaB Cell Lymphoma

Outcome Measures

Primary Outcomes (3)

  • Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability

    24 weeks

  • MTD of universal dual specificity CD19 and CD20 or CD22 CAR-T cells

    The highest dose of universal dual specificity CD19 and CD20 or CD22 CAR-T cells that is estimated to result in defined Dose Limiting Toxicity (DLT) with the exception of allowable 'expected' AEs associated with the intravenous infusion of universal dual s

    4 weeks

  • Copies numbers of CAR in peripheral blood(PB), bone marrow(BM)and lymph nodes

    24 weeks

Secondary Outcomes (3)

  • Six-month Objective response rate of complete remission and partial remission

    24 weeks

  • Six-month Overall survival

    24 weeks

  • Six-month Progression free survival

    24 weeks

Interventions

Universal Dual Specificity CD19 and CD20 or CD22 CAR-T CellsBIOLOGICAL

1. Biological: Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cells 2. Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose. D2: 60% of total dose if patient is stable (no significant toxicity) from prior dose 3. Other: Laboratory Biomarker Analysis

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female participant
  • Years to 70 Years (Child, Adult, Senior)
  • Patient with relapsed or refractory B-cell leukemia or lymphoma
  • Estimated life expectancy ≥ 12 weeks (according to investigator's judgement)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Adequate organ function

You may not qualify if:

  • Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
  • Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
  • Richter's syndrome
  • Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening
  • Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
  • Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
  • Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
  • Patient has an investigational medicinal product within the last 30 days prior to screening
  • Previous treatment with investigational gene or cell therapy medicine products
  • Pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Leukemia, B-CellLymphoma, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphoma

Central Study Contacts

Wenying Zhang

CONTACT

86-10-55499341zhangwenying.1984@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Molecular & Immunological Department, Biotherapeutic Department

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 16, 2018

Study Start

January 2, 2018

Primary Completion

May 20, 2022

Study Completion

May 20, 2022

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

CN(1)