A single-center, open, single-arm I clinical trial of rocotenib combined with murine cd19-car T cells in the treatment of refractory/recurrent acute b-lymphoid leukemia

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000029893

Enrollment

Unknown

Registered

2020-02-16

Start date

2020-02-16

Completion date

Unknown

Last updated

2020-02-17

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

Conditions

Blood disease

Interventions

single arm:Rocotinib combined with mouse CD19-CAR T cell therapy

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1) diagnosis of treatment/recurrence, full expression of tumor surface antigen CD19;Patients with acute b-lymphoblastic leukemia who relapsed after allogeneic hematopoietic stem cell transplantation; 2) male or female patients aged 1-18 years (including 18 years old); 3) no severe allergy; 4) ECOG score 0-2; 5) expected survival time >= 60 days; 6) bone marrow or peripheral blood or immunohistochemical CD19 positive; 7) the informed consent was voluntarily signed by the 18-year-old patient with self-knowledge, and the legal representative (guardian) of the child patient under the age of 18 voluntarily signed the informed consent; 8) CRS occurs >= level 2.

Exclusion criteria

Exclusion criteria: 1) intracranial hypertension or cerebral disturbance of consciousness; 2) symptomatic heart failure or severe arrhythmia; 3) symptoms of severe respiratory failure; 4) with other types of malignant tumors; 5) diffuse intravascular coagulation; 6) serum creatinine and/or urea nitrogen >=1.5 times normal; 7) sepsis or other hard-to-control infection; 8) uncontrolled diabetes; 9) severe mental disorders; 10) obvious intracranial lesions were detected by cranial mri; 11) cerebrospinal fluid detected 20 leukemic cells > 20/ul; 12) the proportion of leukemia cells in blood was >30%; 13) have received an organ transplant; 14) female patients (fertile patients) had positive blood HCG test; 15) hepatitis (including hepatitis b and c), AIDS, syphilis screening positive. 16) bone marrow and peripheral blood chimerism to transform into complete patient type. 17) active viral infection (including but not limited to EBV, cmvemia, herpes virus infection).

Design outcomes

Primary

Measure	Time frame
Safety evaluation index;Pharmacokinetic evaluation index;Efficacy evaluation index;	—

Countries

China

Contacts

Public ContactPan Jing

Beijing Boren Hospital

panj@borenhospital.com+86 18911067969

Outcome results

None listed

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