Status:
UNKNOWN
Senl_1904A and Senl_1904B Chimeric Antigen Receptor （CAR） T-Cell in the Treatment of r/ r Acute B Lymphocytic Leukemia
Lead Sponsor:
Hebei Senlang Biotechnology Inc., Ltd.
Collaborating Sponsors:
Hebei Yanda Ludaopei Hospital
Conditions:
Acute Lymphocytic Leukemia
Eligibility:
All Genders
3-65 years
Phase:
PHASE1
Brief Summary
This is an open, two arms, mask phase I clinical study to evaluate efficacy and safety of two different chimeric antigen receptor T cell immunotherapies (Senl\_1904A and Senl\_1904B) targeting cluster...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03840317
Start Date
January 2 2019
End Date
January 31 2022
Last Update
January 20 2021
Active Locations (1)
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1
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China, 065000