RecruitingEarly Phase 1NCT04662294

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

Clinical Trial for the Safety and Efficacy of CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases


Sponsor

Zhejiang University

Enrollment

108 participants

Start Date

Nov 18, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Inclusion Criteria37

  • Histologically confirmed diagnosis of CD70 AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
  • Relapsed or refractory CD70+ AML (meeting one of the following conditions):
  • CR not achieved after standardized chemotherapy;
  • CR achieved following the first induction, but CR duration is less than 12 months;
  • Ineffectively after first or multiple remedial treatments;
  • or more relapses;
  • The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry);
  • Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
  • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
  • No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
  • Estimated survival time ≥ 3 months;
  • ECOG performance status 0 to 2;
  • Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.
  • No gender and age limit;
  • Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
  • Relapsed or refractory CD70+ NHL (meeting one of the following conditions):
  • No response or relapse after second-line or above chemotherapy regimens;
  • Primary drug resistance;
  • Relapse after auto-HSCT;
  • At least one assessable tumor lesion per Lugano 2014 criteria
  • Histologically confirmed diagnosis of CD70 multiple myeloma (MM):
  • According to the diagnostic criteria of IMWG multiple myeloma, the diagnosis was recurrent / refractory multiple myeloma
  • Cases with recurrent positive minimal residual disease;
  • Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
  • No gender and age limit;
  • Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
  • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
  • No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
  • Estimated survival time ≥ 3 months;
  • ECOG performance status 0 to 2;
  • Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.
  • Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
  • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
  • No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
  • Estimated survival time ≥ 3 months;
  • ECOG performance status 0 to 2;
  • Patients or their legal guardians volunteer to participate in the study and sign the informed consent -

Exclusion Criteria11

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

Interventions

BIOLOGICALCD70 CAR T-cells

Each subject receive CD70 CAR T-cells by intravenous infusion


Locations(1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

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NCT04662294


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