FindTrial
Sign In

An unblinded, uncontrolled, single-center preliminary clinical study to evaluate the safety and efficacy of chimeric antigen-receptor engineered T cell immunotherapy (CART) targeting CD19/CD20/CD22/CD33/CD123/CLL-1/ CD138/BCMA/ CD30 and other cell surface biomarkers in the treatment of hematologic malignancies with positive corresponding biom

An unblinded, uncontrolled, single-center preliminary clinical study to evaluate the safety and efficacy of chimeric antigen-receptor engineered T cell immunotherapy (CART) targeting CD19/CD20/CD22/CD33/CD123/CLL-1/ CD138/BCMA/ CD30 and other cell surface biomarkers in the treatment of hematologic malignancies with positive corresponding biom

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036350
Enrollment
Unknown
Registered
2020-08-22
Start date
2016-06-23
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Hematologic malignancy

Interventions

Case series:Infusion of CART cells

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 6 to 70 years (=3 months 4. Indications: (1) Acute lymphoblastic leukemia - Diagnosed as acute B lymphoblastic leukemia with CD19 and CD20 positive; - Not suitable or unconditional for allogeneic hematopoietic stem cell transplantation; - Recurrent and refractory acute B lymphoblastic leukemia; - Patients with recurrence after autologous hematopoietic stem cell transplantation. (2) Acute myeloid leukemia (AML) - Recurrent, refractory acute myeloid leukemia with positive surface biomarkers such as CD33/CD123/CLL-1 confirmed by MICM typing diagnosis; - Not suitable or unconditional for allogeneic hematopoietic stem cell transplantation; - Patients with recurrent acute myeloid leukemia after autologous hematopoietic stem cell transplantation. (3) Multiple myeloma (MM) - Multiple myeloma with positive antigen such as CD138\BCMA; - Unsuitable, unconditional or unwilling to perform autologous hematopoietic stem cell transplantation;Or there is no suitable donor; - Relapsed, refractory multiple myeloma; - Patients with recurrence after autologous stem cell transplantation. (4) Lymphoma - Recurrent, refractory lymphoma with positive CD19/CD20/CD22/CD30 associated surface biomarkers; - Unsuitable, unconditional or unwilling to perform autologous hematopoietic stem cell transplantation;Or there is no suitable donor; - Patients with recurrence after autologous stem cell transplantation. (5)Receiving bridging therapy or cooperative therapy before hematopoietic stem cell transplantation 5. Viscera functions: - Cardiac function: left ventricular ejection fraction in the last month>40% (echocardiography); - Liver function: alanine aminotransferase and aspartate aminotransferase =60; ECOG score <=2; 7. Medication: - Did not receive systematic chemotherapy within 1 month; - Did not receive other immunotherapy within 3 months.

Exclusion criteria

Exclusion criteria: 1. Active infection; 2. HIV positive; 3. History of myocardial infarction and serious arrhythmia within half a year; 4. Patients with congenital immune deficiency; 5. The patient and/or family members do not agree to the treatment plan; 6. Pregnancy and breastfeeding patients.

Design outcomes

Primary

MeasureTime frame
CAR - T proliferation;Inflammatory indicators;Tumor load;—

Countries

China

Contacts

Public ContactLi Xin

The Third Xiangya Hospital of Central South University

lixiner1975@163.com+86 13808418932

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026