Last updated: October 26, 2021
Sponsor: Zhejiang University
Overall Status: Active - Recruiting
Phase
1
Condition
Multiple Myeloma
Non-hodgkin's Lymphoma
Acute Myeloid Leukemia
Treatment
N/AClinical Study ID
NCT04662294
CD70-001
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Inclusion criteria only for AML:
- Histologically confirmed diagnosis of CD70 AML per the US National ComprehensiveCancer 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 12months;
- Ineffectively after first or multiple remedial treatments;
- 2 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 theinformed consent. Inclusion criteria only for NHL:
- 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 Inclusion criteria only for MM:
- Histologically confirmed diagnosis of CD70 multiple myeloma (MM):
- According to the diagnostic criteria of IMWG multiple myeloma, the diagnosis wasrecurrent / refractory multiple myeloma
- Cases with recurrent positive minimal residual disease;
- Extramedullary leision which is hard to be eradicated by chemotherapy orradiotherapy.
- 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 theinformed consent. Common inclusion criteria :
- 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 theinformed consent -
Exclusion
Exclusion Criteria:
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascularischemia, and cerebrovascular hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severearrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection andbacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Concurrent therapy with systemic steroids within 2 weeks prior to screening, exceptfor the patients recently or currently receiving inhaled steroids;
- Previously treated with any CAR-T cell product or other geneticallymodified T celltherapies;
- 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 orinterfere with the results of study. -
Study Design
Total Participants: 108
Study Start date:
November 18, 2021
Estimated Completion Date:
January 15, 2027
Study Description
Connect with a study center
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
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