Cell Therapy for CD7 Positive Acute Leukemia or Mixed Lineage Leukemia Except Those Who Are Diagnosed With T-ALL/T-LBL Using CD7-Specific CAR-T Cells

Sponsor
Hebei Senlang Biotechnology Inc., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04938115
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
25.7
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: CD7 CART
N/A

Detailed Description

The CARs consist of an anti-CD7 single-chain variable fragment(scFv), 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 CD7 CAR-T cells in patients with CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL

The Secondary research objectives:

To investigate the cytokinetic characteristics of CD7 CAR-T cells in patients with CD7 Positive acute leukemia or mixed lineage leukemia except those who are diagnosed with T-ALL/T-LBL

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cell Therapy for CD7 Positive Acute Leukemia or Mixed Lineage Leukemia Except Those Who Are Diagnosed With T-ALL/T-LBL Using CD7-Specific CAR-T Cells
Actual Study Start Date :
May 10, 2021
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: CD7 CAR-T

Biological: CD7 CART
Biological: CD7 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

Outcome Measures

Primary Outcome Measures

  1. Safety: Incidence and severity of adverse events [First 1 month post CAR-T cells infusion]

    To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

  2. Efficacy: Remission Rate [3 months post CAR-T cells infusion]

    In the presence of extramedullary lesions, complete remission (CR), partial remission (PR), stable disease (SD), disease recurrence or progression (PD) shall be used to describe extramedullary lesions

Secondary Outcome Measures

  1. duration of response (DOR) [24 months post CAR-T cells infusion]

    duration of response (DOR)

  2. Efficacy: progression-free survival (PFS) [24 months post CAR-T cells infusion]

    progression-free survival (PFS) time

  3. CAR-T proliferation [3 months post CAR-T cells infusion]

    the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method

  4. CAR-T proliferation [3 months post CAR-T cells infusion]

    percentage of CD7 CAR- T cells measured by flow cytometry method

  5. Cytokine release [First 1 month post CAR-T cells infusion]

    Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

  6. Pharmacokinetics (PK) indicators [24 months post CAR-T cells infusion]

    the peak concentration of Senl-T7 CAR-T cells amplified in the peripheral blood (Cmax, detected by flow cytometry and qPCR); the time taken to reach the peak concentration (Tmax), and the persistent time of the Senl-T7 CAR-T cells in vivo in patients

  7. Pharmacodynamic (PD) indicators [First 1 month post CAR-T cells infusion]

    the pharmacodynamic change in the clearance of peripheral blood CD7+ cells and the release of the cytokines at each observation time point

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Diagnosis of refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) according to the NCCN 2019.V2, the definition of refractory is failing to achieve complete remission after induction therapy ; the definition of relapse is either peripheral blood or bone marrow;

  2. CD7-positive tumor (≥70% CD7 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory). tumors burden >5%,or MRD+, or new extramedullary lesions reappeared;

  3. Life expectancy greater than 12 weeks;

  4. KPS or Lansky score≥60;

  5. HGB≥70g/L (can be transfused);

  6. oxygen saturation of blood>90%;

  7. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;

  8. Informed consent explained to, understood by and signed by patient/guardian

Exclusion Criteria:
  1. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);

  2. Has an active GvHD;

  3. Has a history of severe pulmonary function damaging;

  4. With other tumors which is/are in advanced malignant and has/have systemic metastasis;

  5. Severe or persistent infection that cannot be effectively controlled;

  6. Merging severe autoimmune diseases or immunodeficiency disease;

  7. Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);

  8. Patients with HIV infection or syphilis infection;

  9. Has a history of serious allergies on Biological products (including antibiotics);

  10. Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human herpesvirus)-6;

  11. Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.;

  12. Have received transplant treatment for less than 6 months in prior to enrollment;

  13. Being pregnant and lactating or having pregnancy within 12 months;

  14. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1He bei Yan da Lu dao pei HospitalBeijingHebeiChina

Sponsors and Collaborators

  • Hebei Senlang Biotechnology Inc., Ltd.

Investigators

  • Principal Investigator: Peihua MD Lu, PhD, Hebei Yanda Ludaopei Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier:
NCT04938115
Other Study ID Numbers:
  • CD7+ mixed lineage leukemia
First Posted:
Jun 24, 2021
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2021