- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04516551
Anti-CD19 Allo-CAR-T Cells for Relapsed B Cell Malignancies After HSCT
Anti-CD19 Donor-derived CAR-T Cells for Patients With Relapsed B Cell Malignancies After Hematopoietic Stem Cell Transplantation: a Multi-center, Uncontrolled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Chongqing
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Chongqing, Chongqing, China, 400037
- Recruiting
- Department of Hematology, Xinqiao Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of relapsed B-cell acute lymphoblastic leukemia (B-ALL).
- Patients have received hematologic stem cell transplantation from matching sibling donor or unrelated donor.
- CD19-positive tumor (>20% CD19 positive blasts by flow cytometry or immunohistochemistry (tissue))
- Hgb ≥ 7.0 (can be transfused)
- Life expectancy greater than 12 weeks
- Informed consent explained to, understood by and signed by the patient/guardian. The patient/guardian is given a copy of informed consent.
Exclusion Criteria:
- Other tumors except cured non-melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast duct cancer in situ, or other malignant tumors with complete remission of more than 5 years);
- Severe mental disorders;
- A history of genetic diseases such as Fanconi anemia, Shudder-Dale syndrome, Costman syndrome, or any other known bone marrow failure syndrome;
- Subjects with II-IV grade acute graft versus host disease GVHD (Glucksberg Standrad) or chronic GVHD.
- Heart disease with grade III-IV heart failure [NYHA classification], myocardial infarction, angioplasty or stenting, unstable angina or other heart diseases with prominent clinical symptoms within one year before admission;
- Subjects with any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, bile drainage tube or pleura/peritoneum/pericardium catheter), should be excluded. (Special central venous catheter is allowed);
- Subjects with a history of CNS lymphoma, CSF malignant cells, or brain metastasis;
- Subjects with a history of CNS disease,such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS;
- Any of the following virological ELISA results are positive: HIV antibody, HCV antibody, TPPA, HBsAg;
- Active infection requiring systematic treatment within 2 weeks before single collection;
- Subjects with known severe allergic reactions to cyclophosphamide or fludarabine, or diagnosed as the allergy;
- History of autoimmune diseases (e.g. Crohn disease, rheumatoid arthritis, systemic lupus erythematosus) that cause end-organ damage or require systemic immunosuppressive medications or systemic disease modifying drugs in the past 2 years;
- Presence of pulmonary fibrosis;
- Subjects who have received other clinical trial treatment within 4 weeks before participating in this trial should be excluded. Or the signing date of informed consent is within 5 half-lives of the last application of another clinical trial (whichever is longer);
- Subjects with poor compliance due to physiological, family, social, geographical and other factors, or those unable to cooperate with the study plan or follow-up;
- At the discretion of the investigator, there are complications requiring systemic corticosteroid therapy (≥ 5mg / day of prednisone or equivalent dose of other corticosteroids) or other immunosuppressive drugs within 6 months after this clinical research treatment;
- The lactating woman who is reluctant to stop breastfeeding;
- Any other condition considered unsuitable by the investigator.
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: anti-CD19 allo-CAR-T
The study will employ dose level cohorts of three patients that will be treated at each level described below, based on the number of T cells to be infused using the "3 + 3" dose-escalation strategy to find MTD followed by a dose-expansion phase at determining optimal dosage. dosage: the number of anti CD19+CD22 CAR T cells -1(if needed) 1×10^6/KG 3×10^6 /KG 6×10^6 /KG 1×10^7/KG Treatment follows a lymphodepletion, chemotherapy regimen that consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) for 3 days or bendamustione (90mg/m2 per day) for two days prior to cell infusion. |
The T cells collected from haploidentical donors have been manufactured to express CAR to binding CD19 on B-cell leukemia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the safety of anti-CD19 allo CAR-T cells
Time Frame: within 4 weeks after infusion
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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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within 4 weeks after infusion
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the efficacy of anti-CD19 allo CAR-T cells
Time Frame: 4 weeks after infusion
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ratio of bone marrow blast cells
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4 weeks after infusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The long-term efficiency
Time Frame: up to 2 years after infusion
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ratio of bone marrow blast cells
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up to 2 years after infusion
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Xi Zhang, MD phD, Xinqiao Hospital of Chongqing
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
- Anti-CD19 allo-CAR-T
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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