NCT05570188WithdrawnPhase 1/2
Anti-CD19 Universal CAR-NK Cells Therapy Combined With HSCT for B Cell Hematologic Malignancies
An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-CD19 Universal CAR-NK(U-CAR-NK) Cells Therapy Combined With Hematopoietic Stem Cell Transplantation(HSCT) for B Cell Hematologic Malignancies
Source: ClinicalTrials.gov · Last updated 30 Nov 2022
Reason given: The PI decides to stop.
Brief summary (registry, in English)
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-CD19 U-CAR-NK Cells Therapy combined with HSCT for B cell hematologic malignancies.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 4 Oct 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Kunming Hope of Health Hospital
- NCT number
- NCT05570188
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had received NK cell therapy or other genetically modified cell therapy within 1 year before screening;
- At least 14 days or at least 5 half-lives of antitumor therapy had elapsed before screening;
- Patients who had undergone hematopoietic stem cell transplantation (ASCT), allogeneic hematopoietic stem cell transplantation (HSCT), or solid organ transplantation within 12 weeks before screening; Grade 2 or higher GVHD requiring immunosuppressive therapy occurred within 2 weeks before screening;
- Have received live attenuated vaccine within 6 weeks before rinsing;
- Had a cerebrovascular accident or seizure within 6 months before screening;
- History of deep venous thrombosis or pulmonary embolism within 6 months before screening;
- A history of myocardial infarction, bypass or stent bypass, unstable angina, or other clinically significant heart disease within 12 months prior to screening;
- Previous history of Alzheimer's disease;
- Autoimmune diseases leading to end-organ damage or requiring systemic immunosuppression (e.g. Crohns, rheumatoid arthritis, systemic lupus erythematosus) within 2 years prior to screening;
- Women who are pregnant or breastfeeding; Or women of childbearing age who have positive pregnancy tests during the screening period; Male or female patients who did not wish to use contraception from the time of signing the informed consent to 1 year after receiving the NK cell infusion;
Other illness
- There are uncontrollable infections;
- Conditions that other researchers deemed inappropriate for participating in the study.
Other
- Patients with atrial or ventricular lymphoma or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression;
Who the study is looking for
- Patients with indications for hematopoietic stem cell transplantation;
- Age ≤75 years old;
- Confirmed B-cell tumor and tumor cells expressing CD19;
- Expected survival time >12 weeks;
- ECOG score is 0-2;
- Adequate liver , kidney and cardiopulmonary function;
- Willingness to complete the informed consent process and to comply with study procedures and visit schedule.
Age in the registry: - to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kunming Hope of Health Hospital | Kunming | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.