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

Study Overview
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Brief Summary
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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。

Official Title
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A Study on the Efficacy, Safety and Cellular Pharmacokinetics of RD13-02 Cell Injection in Patients With Relapsed or Refractory CD7-positive Hematological Malignancies

Conditions
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Neoplasms, Hematologic Neoplasms, Neoplasms by Site, Hematologic Diseases

Intervention / Treatment
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* Drug: RD13-02 cell infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 3-70 Diagnosis of r/r T-ALL/LBL/AML. CD7 positive expression Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening 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 Left ventricular ejection fraction ≥ 50% . Baseline oxygen saturation ≥ 92% on room air. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. The estimated survival time is more than 3 months. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent. Exclusion Criteria: Subjects with concomitant genetic syndromes associated with bone marrow failure states. Isolated extramedullary lesions Subjects with some cardiac conditions will be excluded. With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3). 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. History of malignancy other than non-melanoma skin cancer or carcinoma. Primary immune deficiency. Presence of uncontrolled infections. Subjects with some anticancer therapy before CAR-T infusion will be excluded. Active uncontrolled acute infections. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis. 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RD13-02 cell infusion<br> | Drug: RD13-02 cell infusion<br>* CAR-T cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Overall response rate (ORR) | The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) | Evaluate at 8 weeks after CAR-T infusion | 
| Overall response rate (ORR) | The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) | Evaluate at 12 weeks after CAR-T infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Event-free survival (EFS) | The time from first achieving CR/CRi to relapse or death | Up to 1 years after CAR-T infusion | 
| 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 | 
| Overall survival (OS) | The time from CAR-T infusion to death due to any cause | Up to 1 years after CAR-T infusion |