- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04860817
A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL
Investigating the Safety and Efficacy of Anti-CD7 CAR-T Cell Immunotherapy in Patients With Relapse and Refractory T-cell Acute Lymphoblastic Leukemia or T Lymphoblastic Lymphoma
Study Overview
Status
Intervention / Treatment
Detailed Description
Who can participate? Patients diagnosed with relapsed/refractory T cell leukaemia or lymphoma. Both genders, aged 2-25 years old.
What does the study involve? Enrolled participants are randomly chosen to receive one of three different dose levels of CAR-T cells.
- Dose level one: 0.6×10^7 cells/kg;
- Dose level two: 1×10^7 cells/kg;
- Dose level three: 1.5×10^7 cells/kg. Before CAR-T infusion, all participants will receive a preconditioning therapy including several chemotherapy agents or other interventions that are required to help the effect of the CAR-T cells. After completion of preconditioning therapy, infusion of the CAR-T cells via a tube into the vein needs to start within 1 week. Participants will receive one infusion of CAR-T cells which will take between 15 and 30 mins. All participants will have a blood test before infusion and at 4, 7, 10 and 14 days following infusion to measure their response to the treatment and some further tests will be required in some participants.
What are the possible benefits and risks of participating? The universal CAR-T cells targeting CD7 may lead to durable disease control and long term survival. The main risks of participating include cytokine release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS).
Where is the study run from? Haematology department of 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China (China).
Study Type
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
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Yunnan
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Kunming, Yunnan, China, 650100 P.R.China
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 2 to 25 years
- Diagnosed with relapsed and refractory CD7 + T cell acute lymphocytic leukemia (T-ALL) or relapsed and refractory CD7 + T lymphoblastic lymphoma (T-LBL)
- Quantifiable tumor burden
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1
- Life expectancy ≥12 weeks
Adequate organ function defined as:
- Serum ALT/AST ≤2.5 ULN
- Creatinine clearance (as estimated by Cockcroft Gault) ≥60 mL/min
- PT and APTT≤1.5 ULN
- Total bilirubin ≤1.5 ULN
- Cardiac ejection fraction ≥45%
- No clinically significant ECG findings
- Baseline oxygen saturation >90% on room air
- Recovered from acute toxic effects of prior chemotherapy ≥one week before entering this study
- Agreement to use of medical-approved-contraception during the period of trial and in 1 year after cell transfusion therapy
- Signed informed consent form
Exclusion Criteria:
- Diagnosis of other malignancy (except non-melanoma and cervical carcinoma in situ, bladder cancer, breast cancer that have a disease-free survival of more than 5 years)
- Severe mental disorders
- History of hereditary diseases, including but not limited to: Fanconi anemia, Shut-Dai syndrome, Costman syndrome or any other known bone marrow failure syndrome
- Grade 2-4 acute graft-versus-host disease (GVHD) (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria)
- Grade III-IV heart failure or myocardial infarction, angioplasty or stent placement, unstable angina pectoris, or other clinically prominent heart disease within one year before enrollment
- History or presence of CNS disorder, including but not limited to: seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled
- Severe allergies
- History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
- History or diagnosis of pulmonary fibrosis
- Participation in other clinical trials ≤4 weeks prior to enrollment
- Concomitant disease that require systemic steroids or other immune suppressive therapy during the study period in researcher's judgement
- Patients who are contraindicated to cyclophosphamide, fludarabine
- Allogeneic cell therapy (such as donor lymphocyte infusion, DLI) ≤6 weeks prior to enrollment
- Poor adherence due to physical, family, social, geographic, and other factors, who cannot follow the research plan and follow-up plan
- Pregnant and lactating women
- Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Target CD7 CAR-T cells
Three dose levels will be evaluated.
The CAR-T cells will be administered with Cytoxan and fludarabine.
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Enrolled participants are allocated to one of three different dose levels of target CD7 CAR-T cells. The infusion dose of CAR-T cells will start at low dose and then rise to higher dose after completion of low dose group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with dose-limiting toxicity
Time Frame: up to 4 weeks after target CD7 CAR-T cells infusion
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Dose-limiting toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0) at 4 weeks following target CD7 CAR-T cells infusion
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up to 4 weeks after target CD7 CAR-T cells infusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: 4 weeks, 12 weeks, 24 weeks after target CD7 CAR-T cells infusion
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ORR of patients, determined by National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology: Acute Lymphoblastic Leukemia (2016.V2) for T-ALL response rate and Lugano 2014 for T-LBL response rate.
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4 weeks, 12 weeks, 24 weeks after target CD7 CAR-T cells infusion
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Progression-free survival (PFS)
Time Frame: 24 weeks after target CD7 CAR-T cells infusion
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PFS determined from patient notes at 24 weeks following target CD7 CAR-T cells infusion.
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24 weeks after target CD7 CAR-T cells infusion
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Overall survival (OS)
Time Frame: 24 weeks after target CD7 CAR-T cells infusion
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OS determined from patient notes at 24 weeks.
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24 weeks after target CD7 CAR-T cells infusion
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Duration of remission (DOR)
Time Frame: 24 weeks after target CD7 CAR-T cells infusion
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DOR determined from patient notes at 24 weeks.
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24 weeks after target CD7 CAR-T cells infusion
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GUT03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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