CD371/33/123-CAR T cell combination therapy for refractory/relapsed acute myeloid leukemia in children: a single-center, open, non-random, single-arm clinical trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000034763

Enrollment

Unknown

Registered

2020-07-18

Start date

2020-07-17

Completion date

Unknown

Last updated

2020-07-20

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

Conditions

Refractory/relapsed acute myeloid leukemia in children

Interventions

experimental group:Intravenous CD371/33/123 CAR T

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1) Diagnosis of tumor surface antigens CD371, CD33, CD123 expression, and no CD371/33/123 full-negative tumor subclones, primary drug resistance, relapse of chemotherapy, persistent residual positive or recurrence after allogeneic hematopoietic stem cell transplantation/difficult Treated acute myeloid leukemia patients; 2) Male or female patients, aged 0-18 years (including 18 years old); 3) No severe allergies; 4) Physical condition score 0-2 points; 5) Expected survival time >= 60 days; 6) Bone marrow or peripheral blood or immunohistochemical expression of CD371, CD33, CD123, and no CD371/33/123 full-negative tumor subclones 7) 8-18 year old patients with self-knowledge ability voluntarily sign the informed consent form, and the legal agent (guardian) of the child patient under the age of 8 years voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1) CD371/33/123 total negative tumor subclones exist in flow histology; 2) Intracranial hypertension or brain consciousness disorder; 3) Symptomatic heart failure or severe arrhythmia; 4) Have symptoms of severe respiratory failure; 5) With other types of malignant tumors; 6) Disseminated intravascular coagulation; 7) Serum creatinine and/or urea nitrogen >= 1.5 times the normal value; 8) Suffering from sepsis or other uncontrollable infections; 9) Suffering from uncontrollable diabetes; 10) Severe mental disorders; 11) Head MRI examination shows obvious lesions in the skull; 12) Have undergone organ transplantation (excluding bone marrow transplantation); 13) Female patients (patients with fertility) have a positive blood HCG test; 14) Hepatitis (including hepatitis B and C) and those with positive screening for AIDS and syphilis.

Design outcomes

Primary

Measure	Time frame
Safety evaluation index;Evaluation index of pharmacokinetics;Efficacy evaluation index;	—

Countries

China

Contacts

Public ContactJing Pan

Beijing Boren Hospital

panj@borenhospital.com+86 18911067969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026