CClinicalTrials.gg
Sign In
Status unknownNCT03398967Updated Jan 16, 2018

A Feasibility and Safety Study of Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cell Immunotherapy for Relapsed or Refractory Leukemia and Lymphoma

A Phase 1/2 interventional study of Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cells in B Cell Leukemia and B Cell Lymphoma, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-16.

Sponsored by Chinese PLA General Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
12 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

  1. PRIMARY OBJECTIVES:

    1. To evaluate the feasibility and safety of universal dual specificity CD19 and CD20 or CD22 CAR-T cells in patients with relapsed or refractory leukemia and lymphoma.
    2. To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells. Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to detect and quantify survival of universal dual specificity CD19 and CD20 or CD22 CAR-T cells over time.

  2. SECONDARY OBJECTIVES:

    1. For patients with detectable disease, measure anti-tumor response due to universal dual specificity CD19 and CD20 or CD22 CAR-T cell infusions.
    2. Determine if cellular or humoral host immunity develops against the murine anti-CD19, and assess correlation with loss of detectable universal dual specificity CD19 and CD20 or CD22 CAR-T cells (loss of engraftment).

The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using a "split dose" approach to dosing: 10% on day 0, 30% on day 1 and 60% on day 2.

02

Conditions studied

  • B Cell Leukemia
  • B Cell Lymphoma
03

Who can participate

Ages eligible
12 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female participant
  2. 12 Years to 70 Years (Child, Adult, Senior)
  3. Patient with relapsed or refractory B-cell leukemia or lymphoma
  4. Estimated life expectancy ≥ 12 weeks (according to investigator's judgement)
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  6. Adequate organ function

Exclusion criteria

Exclusion Criteria:

  1. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
  2. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
  3. Richter's syndrome
  4. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening
  5. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
  6. Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
  7. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
  8. Patient has an investigational medicinal product within the last 30 days prior to screening
  9. Previous treatment with investigational gene or cell therapy medicine products
  10. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
  11. Pregnant or nursing women
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Interventions

  • BiologicalUniversal Dual Specificity CD19 and CD20 or CD22 CAR-T Cells

    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

05

What researchers measure

Primary outcomes

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

    Time frame: 24 weeks

  2. 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

    Time frame: 4 weeks

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

    Time frame: 24 weeks

Secondary outcomes

  1. Six-month Objective response rate of complete remission and partial remission

    Time frame: 24 weeks

  2. Six-month Overall survival

    Time frame: 24 weeks

  3. Six-month Progression free survival

    Time frame: 24 weeks

06

Study locations

1 of 1 sites recruiting
  • Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
    Beijing, Beijing 100853, China
    • Weidong Han, Dr. · Contact · hanwdrsw@sina.com · 86-10-13651392893
    • Daihong Liu, Dr. · Contact · daihongrm@163.com · 86-10-55499136
    • Weidong Han, Dr. · Principal investigator
    • Daihong Liu, Dr. · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03398967
Lead sponsor
Chinese PLA General Hospital
Responsible party
Han weidong (Director of Molecular & Immunological Department, Biotherapeutic Department, Chinese PLA General Hospital) — Principal investigator
First posted
Jan 16, 2018
Start date
Jan 2, 2018
Primary completion
May 20, 2022 (estimated)
Completion
May 20, 2022 (estimated)
Last update
Jan 16, 2018

Study contacts

Wenying Zhang
Contact
zhangwenying.1984@163.com
86-10-55499341

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lymphoma→

Other studies from this sponsor

Chinese PLA General Hospital

Start the discussion