Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T Cells

NCT04572308 | Completed Phase 1

• 1 other identifier: CD7 CAR-T for T-ALL/T-LBL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (TLBL).

Conditions

T-cell Acute Lymphoblastic Leukemia/Lymphoma

Keywords

T-ALL，T-LBL , CD7，CAR-T

Outcome Measures

Primary Outcomes (2)

• Safety: Incidence and severity of adverse events

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

  First 1 month post CAR-T cells infusion

• Efficacy: Remission Rate

  Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、partial remission(PR), No remission(NR), overall remission (OR)

  3 months post CAR-T cells infusion

Secondary Outcomes (7)

• duration of response (DOR)

  24 months post CAR-T cells infusion

• Efficacy: progression-free survival (PFS)

  24 months post CAR-T cells infusion

• CAR-T proliferation

  3 months post CAR-T cells infusion

• CAR-T proliferation

  3 months post CAR-T cells infusion

• Cytokine release

  First 1 month post CAR-T cells infusion

Study Arms (1)

CD7 CAR-T

EXPERIMENTAL

Patients will be treated with CD7 CAR-T cells

Biological: CD7 CAR-T

Interventions

CD7 CAR-T BIOLOGICAL

Patients will be treated with CD7 CAR-T cells Biological: CD7 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

CD7 CAR-T

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LBL) according to the NCCN 2019.V2 Guideline. Refractory T-ALL is defined as a patient who has failed to achieve complete remission after induction therapy. Relapsed T-ALL is defined as the reappearance of blasts (5%) in either peripheral blood or bone marrow. Patients whose tumor burden \>5% blasts, or who have persistent positive minimal residual disease (MRD), or have reappearance of extramedullary lesions are also considered eligible.
• 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.
• Life expectancy greater than 12 weeks
• KPS or Lansky score≥60
• HGB≥70g/L
• oxygen saturation of blood\>90%
• Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal
• Informed consent explained to, understood by and signed by patient/guardian.

You may not qualify if:

• 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)
• Has an active GvHD;
• 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；
• Presence of 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 to biological products (including antibiotics);
• Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human herpesvirus)-6.
• Presence of any symtomatic CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
• Received allogeneic hematopoietic stem cell transplantation within 6 months;
• 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.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead

Study Sites (1)

Hebei yanda Ludaopei Hospital

Yanda, Hebei, China

Location

Related Publications (1)

• Velasquez MP. Allogeneic CD7-CAR T cells to bridge the gap? Transplant Cell Ther. 2023 Mar;29(3):139-140. doi: 10.1016/j.jtct.2023.02.006. No abstract available.

  PMID: 36858787 DERIVED

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 1, 2020
• Study Start: October 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

CN (1)