Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL

NCT05626400 | Recruiting

• 1 other identifier: Senl-T7 CAR for T-ALL/T-LBL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, prospective, dose-escalation clinical study to evaluate the safety and efficacy of Senl-T7 in patients with relapsed or refractory CD7+ acute T lymphoblastic leukemia or T lymphoblastic lymphoma.Meanwhile, PK/PD indexes of Senl-T7 were collected.

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 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

• Remission Rate

  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.

  3 months post CAR-T cells infusion

Study Arms (1)

CD-7 CART

EXPERIMENTAL

Patients will be treated with CD7 CAR-T cells

Biological: Senl-T7

Interventions

Senl-T7 BIOLOGICAL

Patients will be treated with CD7 CAR-T cells

CD-7 CART

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• CD7 expression in tumor cells was detected by flow cytometry；
• Life expectancy greater than 12 weeks；
• KPS or Lansky score≥60;
• HGB≥70g/L (can be transfused);
• years old;
• Oxygen saturation of blood#90%#;
• HGB≥70g/L（blood transfusion allowed）;
• 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;
• Merging 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 on Biological products (including antibiotics);
• Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6;
• 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.;
• Have received transplant treatment for less than 6 months in prior to enrollment;
• 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 Hospital

Beijingcun, Hebei, China

RECRUITING

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

Central Study Contacts

Xian Zhang

CONTACT

008618611636172; xian_zhang@126.com

Jianqiang Li, MD, PhD

CONTACT

008615511369555; limmune@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: August 29, 2022
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: November 25, 2022

Record last verified: 2022-08

Locations

CN (1)