CD7 CAR-T for Patients With r/r CD7+ T-ALL/T-LBL
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, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RD13-02 cell infusion
|
Drug: RD13-02 cell infusion
CAR-T cells
|
Outcome Measures
Primary Outcome Measures
- Dose-limiting toxicity and Maximum Tolerated dose [Up to 28 days after CAR-T cells infusion]
The DLT is evaluated as the proportion of patients who experienced adverse events related to RD13-02 that meet the criteria for DLT events after the first infusion.
Secondary Outcome Measures
- Overall response rate,ORR [Evaluate at 4, 8, and 12 weeks after CAR-T infusion]
The proportion of patients with CR (complete remission) /CRi (complete remission with incomplete blood count recovery); The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
- Overall response rate with 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 patients who receive hematopoietic stem cell transplantation
- 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.
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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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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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Sujects with concomitant genetic syndromes associated with bone marrow failure states.
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Sujects 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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Sujects 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 sujects ineligible for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The first affiliated hospital of medical college of zhejiang university | Hangzhou | Zhejiang | China | 310003 |
Sponsors and Collaborators
- He Huang
- Nanjing Bioheng Biotech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BHCT-RD13-02-02