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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05907603
Other study ID # BHCT-RD13-02-06
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date March 8, 2023
Est. completion date March 8, 2025

Study information

Verified date June 2023
Source Xuzhou Medical University
Contact Jiang Cao, MD
Phone +86-13852432263
Email zimu05067@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL/AML, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date March 8, 2025
Est. primary completion date March 8, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years to 70 Years
Eligibility Inclusion Criteria: 1. Age 3-70 2. Diagnosis of r/r T-ALL/LBL/AML. 3. CD7 positive expression 4. Bone marrow lymphoblasts =5% by morphologic evaluation at screening 5. Creatinine clearance (as estimated by Cockcroft Gault) = 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) < 3×upper limit of normal, Total bilirubin < 1.5×upper limit of normal or =1.5mg/dl 6. Left ventricular ejection fraction = 50% . 7. Baseline oxygen saturation = 92% on room air. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 9. The estimated survival time is more than 3 months. 10. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent. Exclusion Criteria: 1. For AML patients, there are acute promyelocytic leukemia (APL) and Abelson Murine Leukemia Viral Oncogene Homolog(BCR-ABL) positive leukemia (chronic myeloid leukemia with acute(CML)-BC). 2. Subjects with concomitant genetic syndromes associated with bone marrow failure states. 3. Subjects with some cardiac conditions will be excluded. 4. History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol. 5. History of malignancy other than non-melanoma skin cancer or carcinoma. 6. Primary immune deficiency. 7. Presence of uncontrolled infections. 8. Subjects with some anticancer therapy before CAR-T infusion will be excluded. 9. Active uncontrolled acute infections. 10. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis. 11. Subjects who are receiving systemic steroid therapy prior to screening. 12. Subjects with acute graft-versus-host disease (GvHD) 13. Having received live/attenuated vaccine within 4 weeks prior to screening. 14. History of allergy to any component of the cell therapy product. 15. Pregnant or breastfeeding women 16. Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RD13-02 cell infusion
CAR-T cells

Locations

Country Name City State
China Affiliated hospital of Xuzhou medical college Xuzhou Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
Kai Lin Xu,MD Nanjing Bioheng Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate (ORR) The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) . Evaluate at 4 weeks after CAR-T infusion
Primary Overall response rate, ORR The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) . Evaluate at 8 weeks after CAR-T infusion
Primary Overall response rate, ORR The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) . Evaluate at 12 weeks after CAR-T infusion
Secondary Objective response rate , ORR The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and partial response (PR). Up to 1 years after CAR-T infusion
Secondary Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow Up to 1 years after CAR-T infusion
Secondary Duration of remission (DOR) The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion Up to 1 years after CAR-T infusion
Secondary Event-free survival (EFS) The time from first achieving CR/CRi to relapse or death Up to 1 years after CAR-T infusion
Secondary The proportion of patients who receive hematopoietic stem cell transplantation The proportion of subjects who achieved remission after infusion who received Hematopoietic Stem Cell Transplantation (HSCT) Up to 1 years after CAR-T infusion
Secondary Overall survival (OS) The time from CAR-T infusion to death due to any cause Up to 1 years after CAR-T infusion
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