Induced-T Cell Like NK Cells for B Cell Malignancies (NCT04747093) | Clinical Trial Compass
UnknownPhase 1/2
Induced-T Cell Like NK Cells for B Cell Malignancies
China12 participantsStarted 2021-01-29
Plain-language summary
Relapsed and refractory B cell malignancies show unfavorable prognosis, especially for adult patients. Now, there is no standard management for these patients. Induced-T cell-like NK cells with chimeric antigen receptor (CAR-ITNK cells) is a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of CAR-ITNK cells infusions in patients with relapsed and refractory B cell malignancies.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with CD19 positive B-cell acute leukemia
* Eastern Cooperative Oncology Group (ECOG) performance status \<2
* ALT/ AST \<3 x normal
* Bilirubin \< 2.0 mg/dl
* Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
* LVEF\< 45%
* Accept white blood cell collection
* Provide informed consent
Exclusion Criteria:
* Previous treatment with investigational gene or cell therapy medicine products
* Active hepatitis B , hepatitis C or HIV infection
* Uncontrolled active infection
* Presence of grade 2-4 acute or extensive chronic GVHD
* Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
* Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* Received non-diagnostic purposes major surgery within the past 4 weeks
* Participated in any other clinical study within the past 4 weeks
* Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
* Pregnancy or breast-feeding women
* Use of prohibited drugs:
* Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to ITNK Cells infusion
* Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 4 weeks prior to ITNK Cells infusion
* GVHD therapies: Any drug used for GVHD must be stopped \> 4 weeks prior to ITNK Cells infusion
* Any situation…
What they're measuring
1
Adverse Events
Timeframe: 12 months
Trial details
NCT IDNCT04747093
SponsorNanfang Hospital, Southern Medical University