Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Sponsor
Hebei Senlang Biotechnology Inc., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04916860
Collaborator
(none)
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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 relapsed and refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma

Condition or Disease Intervention/Treatment Phase
  • Biological: Senl-T7
N/A

Detailed Description

This study is an open, prospective, dose-increasing clinical study with patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma as subjects. In order to evaluate the safety and efficacy of SENL-T7 in patients with CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma, the PK/PD indicators of SENL-T7 are also collected. In this study, no dose grouping is set, and 0.5-2E6 /kg× actual body weight dose is selected for reinfusion according to patients' disease diagnosis and tumor load.

The Main research objectives:

To evaluate the safety and efficacy of SENL-T7 in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

The Secondary research objectives:

To investigate the cellular dynamics of SENL-T7 CAR T cells in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Actual Study Start Date :
Jan 27, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: CD7 CAR-T

Biological: Senl-T7
Patients will be treated with CD7 CAR-T cells

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

    To obsere the efficacy of CAR-T cells after infusion, complete remission (CR), complete remission with incomplete recovery of blood cells (CRi), minimal tumor residual positive(MRD+) or negative (MRD-) CR/CRi, disease recurrence or progression (PD) will be used for evaluation.

Secondary Outcome Measures

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

    duration of response (DOR)

  2. 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

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

    progression-free survival (PFS) time

  4. 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

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

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

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 relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred;

  2. CD7 expression in tumor cells was detected by flow cytometry;

  3. Life expectancy greater than 12 weeks;

  4. KPS or Lansky score≥60;

  5. HGB≥70g/L (can be transfused);

  6. 2-70 years old;

  7. oxygen saturation of blood#90%#;

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

  9. 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

+]);

  1. Patients with HIV infection or syphilis infection;

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

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

  4. 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.;

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

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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hebei yanda Ludaopei Hospital Beijing Hebei China

Sponsors and Collaborators

  • Hebei Senlang Biotechnology Inc., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier:
NCT04916860
Other Study ID Numbers:
  • SenL-T7 for CD7+leukemia/T-LBL
First Posted:
Jun 8, 2021
Last Update Posted:
Jun 28, 2021
Last Verified:
May 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 28, 2021