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Trial Title:
Research Development（RD）13-02 Chimeric Antigen Receptor(CAR) -T Cell Injection for Patients With r/r Cluster Of Differentiation 7（CD7）+ T-Acute Lymphoblastic Leukemia(ALL)/T-Lymphoblastic Lymphoma(LBL) /Acute Myelogenous Leukemia(AML)
NCT ID:
NCT05907603
Condition:
Neoplasms
Hematologic Neoplasms
Hematologic Diseases
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
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:
Research Development 13(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 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.
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. 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.
Gender:
All
Minimum age:
3 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated hospital of Xuzhou medical college
Address:
City:
Xuzhou
Zip:
221000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiang Cao, M.D., Ph.D.
Phone:
+86-13852432263
Email:
zimu05067@163.com
Start date:
March 8, 2023
Completion date:
March 8, 2025
Lead sponsor:
Agency:
Kai Lin Xu，MD
Agency class:
Other
Collaborator:
Agency:
Nanjing Bioheng Biotech Co., Ltd.
Agency class:
Industry
Source:
Xuzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05907603
