- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03840317
Senl_1904A and Senl_1904B Chimeric Antigen Receptor (CAR) T-Cell in the Treatment of r/ r Acute B Lymphocytic Leukemia
Randomized, Parallel-arm, Controlled Trial of Senl_1904A and Senl_1904B Autologous CAR-T Cell Injections in the Treatment of Relapsed and Refractory Acute B Lymphocytic Leukemia(r/r B-ALL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Hebei
-
Langfang, Hebei, China, 065000
- Hebei yanda Ludaopei Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects with acute lymphocytic leukemia who voluntarily signed informed consent and met the following criteria:
Patients with relapsed and refractory acute B lymphocytic leukemia with any of the following:
- Recurrence after remission by chemotherapy or autologous stem cell transplantation (including B-ALL patients with bone marrow recurrence of morphology and recurrence of micro-residual );
- Primary B-ALL patients who cannot be completely relieved by repeated chemotherapy twice or more;
- High-risk initial onset B-ALL patients not completely relieved after 1 or 2 times of chemotherapy but not suitable for re-chemotherapy ;
- Tumor cells confirmed CD19 positive by Flow cytometry (FCM)
- For B-ALL patients with simple extramedullary recurrence , there must be at least one evaluable lesion;
- Eastern Cooperative Oncology Group (ECOG) ≤ 2 points;
- Age 3 - 65 years old;
- The bone marrow tumor load value (morphology) > 5% at the time of enrollment;
- The main organ function needs to meet the above conditions: cardiac ultrasound or multiple gated image acquisition analysis (MUGA) scan indicate the cardiac ejection fraction is ≥50% , and there is no obvious abnormality in the electrocardiogram; blood oxygen saturation≥90%; creatinine ≤1.6mg/dl; alanine amino transferase (ALT) and Aspartate transaminase (AST)≤3 times normal range, total bilirubin(TBil) ≤2.0mg/dl;
- The expected survival time is longer than 3 months;
- The pregnancy test for women of childbearing age must be negative; Subjects with a pregnancy plan must agree to take contraception before the enrollment study and after the study lasts for one year; if the subject is pregnant or suspects of pregnancy, the investigator should be notified immediately
- An informed consent form is required.
Exclusion Criteria:
- 1) Severe cardiac insufficiency; 2) A history of severe pulmonary dysfunction; 3) Combined with other malignant tumors; 4) Combined with serious infections or persistent infection and cannot be effectively controlled; 5) Combined with metabolic diseases (except DM); 6) Combined with severe autoimmune diseases or congenital immune defects; 7) Active hepatitis (HBV DNA or HCVRNA detection positive); 8) HIV infection or syphilis infection; 9) A history of severe allergies to biological products (including antibiotics); 10) Subjects with recurrence after allogeneic hematopoietic stem cell transplantation 11) chronic lymphocytic leukemia(CLL) /myeloproliferative neoplasms with acute lymphoid transformation or CLL transform to ALL ; 12) Any drug that has been used against graft-versus-host disease(GVHD) for nearly 4 weeks, such as methotrexate or other chemotherapeutic drugs, mycophenolate mofetil, immunosuppressive antibodies, etc.; 13) Subjects who have received any anti-CD19 medication; 14) Subjects who have used anti-cluster of differentiation antigen 20(CD20) drugs (such as rituximab) for nearly 4 weeks; 15) Subjects who have participated in any other clinical drug trials in the past six months; 16) Female patients who are pregnant and lactating, or have a pregnancy plan within 12 months; 17) The investigator believes that it may increase the risk of the subject or interfere with the outcome of the test (with a history of severe mental illness, drug abuse and history of addiction).
Exit criteria:
- The subjects request to withdraw from the study before CAR-T infusion
- The subjects seriously violate the protocol
Before CAR-T infusion, the following indicators are still abnormal after treatment:
Platelets <20x10^9/L, hemoglobin ≤80g/L, peripheral finger oxygen <90%, AST / ALT / alkaline phosphatase(ALP) ≥ 2.5 upper limits of normal(ULN), total bilirubin ≥ 1.5ULN , creatinine clearance rate <70ml / min, left ventricular ejection fraction <50%, the researcher judged that the test needs to be terminated early;
- The therapeutic dose of steroids was not stopped within 72 hours prior to CAR-T infusion and the investigator determined that the trial needs to be terminated . However, the following physiologically acceptable doses of steroids are permissible: hydrocortisone or equivalent <6-12 mg/m2/day ;
- Not enough T cells for manufacture standard CAR-T cells
- Other serious adverse events occurred
- MRD become negative after preconditioning regiment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Senl_1904A CD19 CAR-T
Autologous CD19-targeting CAR T cells, dosage 3*10^5/kg, intravenous injection once
|
Autologous CD19-targeting CAR T cells
|
Experimental: Senl_1904B CD19 CAR-T
Autologous CD19-targeting CAR T cells,dosage 3*10^5/kg, intravenous injection once
|
Autologous CD19-targeting CAR T cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor load
Time Frame: up to one month
|
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
|
up to one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAR T cell expansion
Time Frame: up to one month
|
The percentage of CAR-T cells (CAR+/CD3+ T cells) in the bone marrow samples, quantified by flow cytometry.
|
up to one month
|
CAR T cell persistence
Time Frame: up to one month
|
The method to detect CAR-T cell persistence is by determining the exact copies of CAR per ug DNA in BM through quantitative polymerase chain reaction(qPCR)
|
up to one month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Peihua Lu, PhD&MD, Hebei yanda Ludaopei Hospital
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Senl_1904A & Senl_1904B CAR-T
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.
Clinical Trials on Acute Lymphocytic Leukemia
-
Eastern Cooperative Oncology GroupCompletedAdult Patients (Over 55) With Acute Non-Lymphocytic Leukemia
-
Stanford UniversityTerminatedLeukemia | Leukemia, Lymphocytic, Acute | Leukemia Acute Promyelocytic Leukemia (APL) | Leukemia Acute Lymphoid Leukemia (ALL) | Leukemia Chronic Myelogenous Leukemia (CML) | Leukemia Acute Myeloid Leukemia (AML) | Leukemia Chronic Lymphocytic Leukemia (CLL)United States
-
Daiichi Sankyo, Inc.TerminatedLeukemia, Myeloid, Acute | Leukemia, Lymphocytic, AcuteUnited States
-
University of MinnesotaChildren's Cancer Research Fund United StatesTerminatedLymphoblastic Lymphoma | Brain Tumors | Lymphoblastic Leukemia, Acute, Childhood | Lymphoblastic Leukemia | Leukemia, Lymphocytic, Acute | Leukemia, Lymphoblastic, Acute | Brain Neoplasms, Malignant | ALL, Childhood | Leukemia, Lymphoblastic, Acute, Philadelphia-Positive | Lymphoblastic Leukemia, Acute | Leukemia... and other conditionsUnited States
-
Genzyme, a Sanofi CompanyCompletedSolid Tumors | Leukemia, Myelocytic, Acute, Pediatric | Leukemia, Lymphocytic, Acute, Pediatric | Leukemia, Lymphocytic, Acute, Adult | Leukemia, Myelocytic, Acute, Adult | Myelodysplastic Syndromes, AdultUnited States
-
First Affiliated Hospital of Wenzhou Medical UniversitySecond Affiliated Hospital of Nanchang University; Hrain Biotechnology Co.,...UnknownHematopoietic/Lymphoid Cancer | Adult Acute Lymphoblastic Leukemia in Remission | B-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | B-cell Adult Acute Lymphoblastic LeukemiaChina
-
Sidney Kimmel Comprehensive Cancer Center at Johns...CompletedAcute Lymphoblastic Leukemia | Acute Myelogenous Leukemia (AML) | Acute Lymphocytic Leukemia (ALL) | Acute Promyelocytic Leukemia (APL)United States
-
Goethe UniversityCompletedAdult Acute Lymphocytic LeukemiaGermany
-
Shanxi Province Cancer HospitalShanghai Ultra-T Immune Therapeutics Co. LTDRecruitingAcute Lymphocytic Leukemia, B-CellChina
-
Proacta, IncorporatedUnknownAcute Lymphocytic Leukemia | Acute Myelogenous LeukemiaUnited States
Clinical Trials on Autologous CD19-targeting CAR T cells
-
Hebei Senlang Biotechnology Inc., Ltd.The Second Hospital of Hebei Medical UniversityUnknown
-
Uppsala UniversityKarolinska University Hospital; Uppsala University Hospital; AFA Insurance; Swedish...CompletedB Cell Lymphoma | B Cell LeukemiaSweden
-
Miltenyi Biomedicine GmbHRecruitingB-cell Lymphoma Refractory | B-cell Lymphoma Recurrent | Acute Lymphoblastic Leukemia Recurrent | Chronic Lymphocytic Leukemia Recurrent | Chronic Lymphocytic Leukemia RefractoryGermany
-
Miltenyi Biomedicine GmbHNot yet recruiting
-
PersonGen BioTherapeutics (Suzhou) Co., Ltd.Anhui Provincial HospitalRecruiting
-
Fuda Cancer Hospital, GuangzhouWithdrawn
-
Zhejiang UniversityYake Biotechnology Ltd.RecruitingB-Cell Acute Lymphoblastic Leukemia, AdultChina
-
Zhejiang UniversityYake Biotechnology Ltd.RecruitingB-Cell Acute Lymphoblastic Leukemia, AdultChina
-
The First Affiliated Hospital of Nanchang UniversityUnknownRelapsed or Refractory Multiple MyelomaChina
-
Zhejiang UniversityYake Biotechnology Ltd.RecruitingNon-hodgkin Lymphoma,B CellChina