Research Development13(RD13)-02 Cell Injection in Patients With Relapsed or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematological Malignancies

Launched by MEI HENG · Jun 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CD7 Chimeric Antigen Receptor-T (CAR-T) therapy for patients with specific types of leukemia and lymphoma that are not responding to other treatments. The goal is to see how safe this therapy is and how it works in the body. This trial is open to children and young adults aged 3 to 70 who have been diagnosed with relapsed or refractory T-Acute Lymphoblastic Leukemia (ALL), Lymphoblastic Lymphoma (LBL), or Acute Myelogenous Leukemia (AML) and have a particular marker called CD7 on their cancer cells.

To participate, patients need to have at least 5% of certain cancer cells in their bone marrow and meet other health criteria, such as having a good heart function and stable oxygen levels. Participants will receive the CAR-T therapy and will be closely monitored for how they respond and any side effects. It’s important to note that certain health conditions, active infections, or recent treatments might make someone ineligible for this trial. If you or a loved one might be interested, the study team will provide more information and help with any questions.

Gender

ALL

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.