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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05923541
Other study ID # BHCT-RD13-02-11
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date June 30, 2023
Est. completion date June 7, 2026

Study information

Verified date June 2023
Source Henan Cancer Hospital
Contact Shu Ke Zhou, Dr.
Phone 13674902391
Email drzhouks77@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, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 7, 2026
Est. primary completion date June 7, 2025
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. 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. 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. Subjects with concomitant genetic syndromes associated with bone marrow failure states. 2. Isolated extramedullary lesions 3. Subjects with some cardiac conditions will be excluded. 4. With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade CNS3. 5. 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. 6. History of malignancy other than non-melanoma skin cancer or carcinoma. 7. Primary immune deficiency. 8. Presence of uncontrolled infections. 9. Sujects with some anticancer therapy before CAR-T infusion will be excluded. 10. Active uncontrolled acute infections. 11. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis. 12. Subjects who are receiving systemic steroid therapy prior to screening. 13. Subjects with acute graft-versus-host disease (GvHD) 14. Having received live/attenuated vaccine within 4 weeks prior to screening. 15. History of allergy to any component of the cell therapy product. 16. Pregnant or breastfeeding women 17. Any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RD13-02 cell infusion
Universal CAR-T cells targeting CD7

Locations

Country Name City State
China Henan Cancer Hospital Zhengzhou Henan

Sponsors (2)

Lead Sponsor Collaborator
Henan Cancer Hospital 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 CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response). 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) and PR (partial response). 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) and PR (partial response). Evaluate at 12 weeks after CAR-T infusion
Secondary Overall response rate with 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 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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