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)
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Research Development 13(RD13)-02 cell infusion drugs use generic name : RD13-02 CAR-T cell injection ; dosage form : Cell injection ; dosage : 2×10^8 CAR+ T cells ; frequency : Once. |
Drug: RD13-02 cell infusion
CAR-T cells
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Outcome Measures
Primary Outcome Measures
- Overall response rate (ORR) [Evaluate at 4 weeks after CAR-T infusion]
The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) .
- Overall response rate, ORR [Evaluate at 8 weeks after CAR-T infusion]
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .
- Overall response rate, ORR [Evaluate at 12 weeks after CAR-T infusion]
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .
Secondary Outcome Measures
- Objective response rate , ORR [Up to 1 years after CAR-T infusion]
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and partial response (PR).
- Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR [Up to 1 years after CAR-T infusion]
Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow
- Duration of remission (DOR) [Up to 1 years after CAR-T infusion]
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
- Event-free survival (EFS) [Up to 1 years after CAR-T infusion]
The time from first achieving CR/CRi to relapse or death
- The proportion of patients who receive hematopoietic stem cell transplantation [Up to 1 years after CAR-T infusion]
The proportion of subjects who achieved remission after infusion who received Hematopoietic Stem Cell Transplantation (HSCT)
- Overall survival (OS) [Up to 1 years after CAR-T infusion]
The time from CAR-T infusion to death due to any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 3-70
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Diagnosis of r/r T-ALL/LBL/AML.
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CD7 positive expression
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Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
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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
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Left ventricular ejection fraction ≥ 50% .
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Baseline oxygen saturation ≥ 92% on room air.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
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The estimated survival time is more than 3 months.
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Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion Criteria:
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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).
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Subjects with concomitant genetic syndromes associated with bone marrow failure states.
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Subjects with some cardiac conditions will be excluded.
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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.
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History of malignancy other than non-melanoma skin cancer or carcinoma.
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Primary immune deficiency.
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Presence of uncontrolled infections.
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Subjects with some anticancer therapy before CAR-T infusion will be excluded.
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Active uncontrolled acute infections.
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Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
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Subjects who are receiving systemic steroid therapy prior to screening.
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Subjects with acute graft-versus-host disease (GvHD)
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Having received live/attenuated vaccine within 4 weeks prior to screening.
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History of allergy to any component of the cell therapy product.
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Pregnant or breastfeeding women
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Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Affiliated hospital of Xuzhou medical college | Xuzhou | Jiangsu | China | 221000 |
Sponsors and Collaborators
- Kai Lin Xu,MD
- Nanjing Bioheng Biotech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BHCT-RD13-02-06