Tests CD70 CAR T-cell treatment in blood cancers with CD70 protein
Tests CD70 CAR T-cells in people with CD70-positive leukemia, lymphoma or myeloma.
Plain-language title generated from the registry record
Registry title: CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Early phase 1
Where in China
- The first affiliated hospital of medical college of zhejiang universityHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhejiang University
- Trial code
- NCT04662294
- Record updated
- 4 November 2021
- Original description
A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseasesRead full original descriptionShow less
Clinical Trial for the Safety and Efficacy of CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases
A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases
Inclusion: 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; 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; 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 -.
Exclusion: 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; History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Creatinine >2.5mg/dl, or ALT / AST>3 times of normal amounts, or bilirubin>2.0 mg/dl; Pregnant (or lactating) women; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study. -.