Actively Recruiting

Early Phase 1
All Genders
NCT04662294

CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

Led by Zhejiang University · Updated on 2021-11-04

108

Participants Needed

1

Research Sites

269 weeks

Total Duration

On this page

Sponsors

Z

Zhejiang University

Lead Sponsor

Y

Yake Biotechnology Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases

CONDITIONS

Official Title

CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion criteria only for AML:

  1. Histologically confirmed diagnosis of CD70 AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);

  2. Relapsed or refractory CD70+ AML (meeting one of the following conditions):

    1. CR not achieved after standardized chemotherapy;
    2. CR achieved following the first induction, but CR duration is less than 12 months;
    3. Ineffectively after first or multiple remedial treatments;
    4. 2 or more relapses;
  3. The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flowcytometry);

  4. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;

  5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;

  6. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;

  7. Estimated survival time ≥ 3 months;

  8. ECOG performance status 0 to 2;

  9. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Inclusion criteria only for NHL:

  1. No gender and age limit;

  2. Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);

  3. Relapsed or refractory CD70+ NHL (meeting one of the following conditions):

    1. No response or relapse after second-line or above chemotherapy regimens;
    2. Primary drug resistance;
    3. Relapse after auto-HSCT;
  4. At least one assessable tumor lesion per Lugano 2014 criteria

Inclusion criteria only for MM:

  1. Histologically confirmed diagnosis of CD70 multiple myeloma (MM):

    1. According to the diagnostic criteria of IMWG multiple myeloma, the diagnosis was recurrent / refractory multiple myeloma
    2. Cases with recurrent positive minimal residual disease;
    3. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
  2. No gender and age limit;

  3. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;

  4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;

  5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;

  6. Estimated survival time ≥ 3 months;

  7. ECOG performance status 0 to 2;

  8. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Common inclusion criteria :

  1. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
  2. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
  3. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
  4. Estimated survival time ≥ 3 months;
  5. ECOG performance status 0 to 2;
  6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent -
Not Eligible

You will not qualify if you...

  1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  3. Pregnant (or lactating) women;
  4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  5. Active infection of hepatitis B virus or hepatitis C virus;
  6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
  7. Previously treated with any CAR-T cell product or other geneticallymodified T cell therapies;
  8. Creatinine >2.5mg/dl, or ALT / AST>3 times of normal amounts, or bilirubin>2.0 mg/dl;
  9. Other uncontrolled diseases that were not suitable for this trial;
  10. Patients with HIV infection;
  11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study. -

AI-Screening

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Trial Site Locations

Total: 1 location

1

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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Research Team

H

He Huang, PhD

CONTACT

Y

Yongxian Hu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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