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One-arm, non-blind safety and efficacy of autologous CLL1/CD123-CAR-T in patients with relapsed and refractory acute myeloid leukemia

One-arm, non-blind safety and efficacy of autologous CLL1/CD123-CAR-T in patients with relapsed and refractory acute myeloid leukemia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027684
Enrollment
Unknown
Registered
2019-11-23
Start date
2019-11-20
Completion date
Unknown
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed refractory acute myeloid leukemia

Interventions

single arm:autologous CLL1/CD123-CAR-T

Sponsors

Dongguan Taixin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Acute myeloid leukemia (AML) diagnosed as CLL1/CD123-positive, relapsed during chemotherapy, or primary drug resistance, or complete hematologic remission after 1 course of hematologic relapse chemotherapy after withdrawal (standard reference NCCN, 2015.2); 2) Aged 1-70 years; 3) Patients >= 18 years old have self-knowledge ability and can sign informed and voluntary consent; the child's guardian or patient entrusted person joins the test after signing the informed and voluntary consent form. 4) The patient's main tissues and organs function well: a. Liver function: ALT/AST= 95%; d. Cardiac function: left ventricular ejection fraction (LVEF) >= 40%.

Exclusion criteria

Exclusion criteria: 1) intracranial hypertension or unconsciousness; 2) symptomatic heart failure or severe arrhythmia; 3) respiratory failure; 4) with other types of malignant tumors; 5) diffuse vascular internal coagulation; 6) serum creatinine and / or urea nitrogen >= 1.5 times the normal value; 7) sepsis or other uncontrollable infections; 8) Uncontrollable diabetes; 9) severe mental disorders; 10) Head MRI examination has obvious lesions in the skull; 11) Cerebrospinal fluid examination of leukemia cells > 20 / ul; 12) WHO physical status classification >= 3; 13) Organ transplant recipients; 14) Pregnant and lactating women. 15) Active hepatitis B/C virus: defined as DNA > 500 IU/ml; patients infected with HIV or syphilis; Patients who participate in clinical trials must meet the inclusion criteria and do not meet the exclusion criteria.

Design outcomes

Primary

MeasureTime frame
Overall survival;

Countries

China

Contacts

Public ContactChunfu Li

Dongguan Taixin Hospital

chunfu.li@gzcf-blood.com+86 18675865379

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026