- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04546893
Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia
Study Overview
Detailed Description
The CARs consist of an anti-CD19 single-chain variable fragment(scFv) that was derived from the FMC63 mouse hybridoma, a portion of the human CD137(4-1BB) molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
The Main research objectives:
To evaluate the safety and efficacy of 1904B in patients with recurrent or refractory B-ALL
The Secondary research objectives:
To investigate the cytokinetic characteristics of 1904B in patients with recurrent or refractory B-ALL
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sanhe
-
Hebei, Sanhe, China, 065200
- Recruiting
- Hebei yanda Ludaopei Hospital
-
-
Yizhuang
-
Beijing, Yizhuang, China, 100000
- Recruiting
- BeiJing Ludaopei Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
- A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;
- ECOG Scores: 0~2
- CD19 positivewere detected by immunohistochemistry or flow cytometry;
- Estimated survival time>3 months;
- Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.
Exclusion Criteria:
- Serious cardiac insufficiency;
- Has a history of severe pulmonary function damaging;
- With other tumors which is/are in advanced malignant and has/have systemic metastasis;
- Severe or persistent infection that cannot be effectively controlled;
- Merging severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);
- Patients with HIV infection or syphilis infection;
- Has a history of serious allergies on Biological products (including antibiotics);
- Being pregnant and lactating or having pregnancy within 12 months;
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
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: 1904B CAR-T
Patients will be treated with CD19 CAR-T cells
|
Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: Remission Rate
Time Frame: 3 months post CAR-T cells infusion
|
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
|
3 months post CAR-T cells infusion
|
Safety: Incidence and severity of adverse events
Time Frame: First month post CAR-T cells infusion
|
To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
|
First month post CAR-T cells infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy:duration of response (DOR)
Time Frame: 24 months post CAR-T cells infusion
|
duration of response (DOR)
|
24 months post CAR-T cells infusion
|
Efficacy: progression-free survival (PFS)
Time Frame: 24 months post CAR-T cells infusion
|
progression-free survival (PFS) time
|
24 months post CAR-T cells infusion
|
CAR-T proliferation
Time Frame: 3 months post CAR-T cells infusion
|
the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method
|
3 months post CAR-T cells infusion
|
Cytokine release
Time Frame: First month post CAR-T cells infusion
|
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
|
First month post CAR-T cells infusion
|
Collaborators and Investigators
Investigators
- Principal Investigator: Peihua Lu, PhD&MD, Hebei yanda Ludaopei Hospital
Study record dates
Study Major Dates
Study Start (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1904B for B-ALL
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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