A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL

NCT04860817 | Withdrawn Early Phase 1

• 1 other identifier: GUT03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

T cells are a type of immune cell. Like other cells of the body, T Cells can develop cancer. T cell cancers mainly include T cell leukaemia and T cell lymphoma, both of which have a relatively poor prognosis. Currently, patients with relapsed/refractory type (the name given to cancer that reappears or grows again after a period of no changes or signs of cancer) of this leukaemia or lymphoma have limited choices for treatment. CAR-T cells are immune cells that are engineered to target specific cell markers. For example, CAR-T cells targeting the marker CD19 have shown great effectiveness in the treatment of B cell tumors that carry this marker. Here investigators construct a new universal CAR-T design targeting CD7 which is found on the cells of relapsed/refractory type T cell leukaemia and lymphoma and hope to test its safety and efficiency in the treatment of relapsed/refractory type T cell leukaemia and lymphoma.

Conditions

T-cell Acute Lymphoblastic Leukemia; T-lymphoblastic Lymphoma

Keywords

CAR-T; CD7; T-ALL/LBL

Outcome Measures

Primary Outcomes (1)

• Number of patients with dose-limiting toxicity

  Dose-limiting toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0) at 4 weeks following target CD7 CAR-T cells infusion

  up to 4 weeks after target CD7 CAR-T cells infusion

Secondary Outcomes (4)

• Overall response rate (ORR)

  4 weeks, 12 weeks, 24 weeks after target CD7 CAR-T cells infusion

• Progression-free survival (PFS)

  24 weeks after target CD7 CAR-T cells infusion

• Overall survival (OS)

  24 weeks after target CD7 CAR-T cells infusion

• Duration of remission (DOR)

  24 weeks after target CD7 CAR-T cells infusion

Study Arms (1)

Target CD7 CAR-T cells

EXPERIMENTAL

Three dose levels will be evaluated. The CAR-T cells will be administered with Cytoxan and fludarabine.

Biological: Target CD7 CAR-T cells

Interventions

Target CD7 CAR-T cells BIOLOGICAL

Enrolled participants are allocated to one of three different dose levels of target CD7 CAR-T cells. The infusion dose of CAR-T cells will start at low dose and then rise to higher dose after completion of low dose group. 1. Dose level one: 0.6×10\^7 cells/kg; 2. Dose level two: 1×10\^7 cells/kg; 3. Dose level three: 1.5×10\^7 cells/kg. Before CAR-T infusion, all participants will receive a preconditioning therapy suggested as: Fludarabine 30 mg/m\^2×6d, Cyclophosphamide 300 mg/m\^2×6d or Cyclophosphamide 600 mg/m\^2×6d. After completion of preconditioning therapy, infusion of CAR-T cells needs to start within 1 week. Participants will receive one infusion of CAR-T cells which will take between 15 and 30 mins.

Target CD7 CAR-T cells

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 25 years
• Diagnosed with relapsed and refractory CD7 + T cell acute lymphocytic leukemia (T-ALL) or relapsed and refractory CD7 + T lymphoblastic lymphoma (T-LBL)
• Quantifiable tumor burden
• Eastern cooperative oncology group (ECOG) performance status of 0 to 1
• Life expectancy ≥12 weeks
• Adequate organ function defined as:
• Serum ALT/AST ≤2.5 ULN
• Creatinine clearance (as estimated by Cockcroft Gault) ≥60 mL/min
• PT and APTT≤1.5 ULN
• Total bilirubin ≤1.5 ULN
• Cardiac ejection fraction ≥45%
• No clinically significant ECG findings
• Baseline oxygen saturation \>90% on room air
• Recovered from acute toxic effects of prior chemotherapy ≥one week before entering this study
• Agreement to use of medical-approved-contraception during the period of trial and in 1 year after cell transfusion therapy

You may not qualify if:

• Diagnosis of other malignancy (except non-melanoma and cervical carcinoma in situ, bladder cancer, breast cancer that have a disease-free survival of more than 5 years)
• Severe mental disorders
• History of hereditary diseases, including but not limited to: Fanconi anemia, Shut-Dai syndrome, Costman syndrome or any other known bone marrow failure syndrome
• Grade 2-4 acute graft-versus-host disease (GVHD) (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria)
• Grade III-IV heart failure or myocardial infarction, angioplasty or stent placement, unstable angina pectoris, or other clinically prominent heart disease within one year before enrollment
• History or presence of CNS disorder, including but not limited to: seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
• Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA
• Presence of fungal, bacterial, viral, or other infection that is uncontrolled
• Severe allergies
• History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
• History or diagnosis of pulmonary fibrosis
• Participation in other clinical trials ≤4 weeks prior to enrollment
• Concomitant disease that require systemic steroids or other immune suppressive therapy during the study period in researcher's judgement
• Patients who are contraindicated to cyclophosphamide, fludarabine
• Allogeneic cell therapy (such as donor lymphocyte infusion, DLI) ≤6 weeks prior to enrollment

Sponsors & Collaborators

• 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China: lead

Study Sites (1)

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Kunming, Yunnan, 650100 P.R.China, China

Location

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-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 Officials

• Sanbin Wang, Doctor

  920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: December 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: November 1, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)