Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
NCT05858814

RC1012 Injection (Allo-DNT Cells) for the Prevention of Relapse in AML Patients After Allo-HSCT

Led by Guangdong Ruishun Biotech Co., Ltd · Updated on 2023-05-19

72

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

Sponsors

G

Guangdong Ruishun Biotech Co., Ltd

Lead Sponsor

A

Anhui Provincial Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

To evaluate the safety and tolerability of RC1012 injection infusion in AML Patients after Allo-HSCT

CONDITIONS

Official Title

RC1012 Injection (Allo-DNT Cells) for the Prevention of Relapse in AML Patients After Allo-HSCT

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign informed consent and plan to complete study procedures
  • Aged 18 to 70 years, any gender
  • Diagnosed with AML according to WHO 2016 criteria
  • Received allogeneic HSCT within 60-100 days with less than 5% malignant primitive cells in bone marrow and complete donor chimerism by STR-PCR
  • Have one or more high-risk factors for relapse after allo-HSCT, including failure to achieve remission after two induction chemotherapy courses, prior MDS or MPN, high leukocyte count with CNS leukemia, positive minimal residual disease before HSCT, non-remission or disease progression before HSCT, or cytogenetic high-risk factors
  • Recovered from prior treatment toxicity with CTCAE grade less than 2 (unless tumor-related)
  • ECOG performance status 0 to 1
  • Adequate organ function including AST and ALT ≤ 3 times ULN, total bilirubin ≤1.5 times ULN (with exceptions for Gilbert syndrome), creatinine ≤1.5 times ULN or creatinine clearance ≥60 ml/min, hemoglobin ≥80 g/L or maintained after transfusion, INR and APTT ≤1.5 times ULN, absolute neutrophil count ≥1.5 x 10^9/L, platelet count ≥50 x 10^9/L or maintained after transfusion, and left ventricular ejection fraction ≥45%
  • Female patients of childbearing potential must have a negative pregnancy test at screening and all patients of childbearing potential must agree to effective contraception for at least six months from consent until end of infusion
  • Female patients without childbearing potential defined by hysterectomy, bilateral oophorectomy, ovarian failure, or post-menopausal status (≥12 months)
Not Eligible

You will not qualify if you...

  • Morphological relapse of leukemia or positive minimal residual disease after allo-HSCT
  • Extramedullary infiltration of leukemia
  • Other malignancies within 5 years prior to screening, except certain treated cancers
  • Severe respiratory diseases including severe interstitial lung disease, COPD, pulmonary insufficiency, or symptomatic bronchospasm
  • History of neurological or psychiatric disorders such as epilepsy or dementia
  • Active central nervous system invasion or cranial neuropathy
  • Positive tests for hepatitis B, hepatitis C, HIV, cytomegalovirus, or syphilis outside normal ranges
  • Allergy to RC1012 injection excipients or other recommended drugs
  • Serious cardiac diseases including severe arrhythmia, unstable angina, heart attack, NYHA class III/IV cardiac insufficiency, or refractory hypertension
  • Previous or planned organ transplant other than HSCT
  • Received or planning to receive other maintenance therapy drugs after HSCT
  • Acute graft-versus-host disease grade III-IV or extensive chronic graft-versus-host disease
  • Active neurological autoimmune or inflammatory diseases like Guillain-Barre Syndrome or ALS
  • Clinically significant active cerebrovascular disease such as cerebral edema or PRES
  • Life expectancy less than 3 months
  • Participation in other clinical studies within 3 months prior to screening
  • Medical contraindications or other conditions placing participant at unacceptable risk per investigator judgment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Hospital of the University of Science and Technology of China

Hefei, Anhui, China, 230001

Actively Recruiting

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Research Team

X

Xiaoyu Zhu, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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