Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
Inclusion criteria only for AML:
-
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;
- 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 the informed 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 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.
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 the informed consent -
You will not qualify if you...
- 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. -
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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
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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