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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Withdrawn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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Kunming Hope of Health HospitalKunmingChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.