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Trial Title:
Research Development13(RD13)-02 Cell Injection in Patients With Relapsed or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematological Malignancies
NCT ID:
NCT05895994
Condition:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RD13-02 cell infusion
Description:
CAR-T cells
Arm group label:
RD13-02 cell infusion
Summary:
This is a single-arm, open-label, single-center, phase I study. The primary objective is
to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients
with CD7-positive relapsed or refractory T-Acute Lymphoblastic
Leukemia(ALL)/Lymphoblastic Lymphoma(LBL)/Acute Myelogenous Leukemia(AML), and to
evaluate the pharmacokinetics of CD7 CAR-T in patients。
Criteria for eligibility:
Criteria:
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. 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 Central Nervous System3(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. Subjects 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.
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
subjects ineligible for the study.
Gender:
All
Minimum age:
3 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Union Hospital, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Heng Mei, M.D., Ph.D
Email:
hmei@hust.edu.cn
Contact backup:
Last name:
Yinqiang Zhang
Phone:
15007101371
Email:
zyq_107@126.com
Investigator:
Last name:
Heng Mei, M.D., Ph.D
Email:
Principal Investigator
Start date:
March 10, 2023
Completion date:
February 20, 2026
Lead sponsor:
Agency:
MEI HENG
Agency class:
Other
Collaborator:
Agency:
Nanjing Bioheng Biotech Co., Ltd.
Agency class:
Industry
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05895994
