CCT301-38 CAR-T in Patients With Relapsed or Refractory AXL Positive Sarcomas

NCT05128786 | Terminated Phase 1

• 1 other identifier: CCT301-38-SAR
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is to investigate the safety and tolerability of CCT301-38 CAR modified autologous T cells (CCT301-38) in subjects with relapsed or refractory AXL positive sarcomas

Conditions

SAR

Keywords

AXL, CAR-T, CCT301-38, sarcoma; CAR-T; CCT301-38; sarcoma

Outcome Measures

Primary Outcomes (1)

• DLT

  To assess the safety and tolerability of CCT301-38 cell therapy for patients with AXL-positive (IHC 1+ or greater in ≥50% tumor cells) relapsed or refractory sarcomas.

  28 days following infusion

Secondary Outcomes (7)

• ORR

  Up to 52 weeks

• DCR

  Up to 52 weeks

• DOR

  Up to 52 weeks

• PFS

  Up to 52 weeks

• TEAE

  Up to 52 weeks

Study Arms (1)

CCT301-38

EXPERIMENTAL

To determine the safety, tolerability, DLT and MTD of CCT301-38 cell therapy in patients with AXL-positive relapsed or refractory sarcomas.

Biological: CCT301-38

Interventions

CCT301-38 BIOLOGICAL

Blood will be collected from subjects to isolate peripheral blood mononuclear cells for the production of CCT301-38. Subjects will receive the conditioning chemotherapy regimen of cyclophosphamide and fludarabine for lymphodepletion followed by a single or multiple dose of CCT301-38 via intravenous injection.

CCT301-38

Eligibility Criteria

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

You may qualify if:

• Patients with willingness to be in the study and follow all study procedures, and capable of providing informed consent
• Male or female aged 18-70 years;
• Patients with unresectable, locally advanced or metastatic relapse/refractory sarcomas that have failed at least the front line standard treatment confirmed by histology or cytology;
• At least one measurable lesion, i.e. the length of non-lymph node lesions examined according to CT cross-sectional scanning or magnetic resonance imaging (MRI), or the short diameter of the lymph node lesions is ≥15 mm according to RECIST 1.1, and the FDG PET signal from the measurable lesion is \> 3 SUV;
• Tumors with AXL positive (IHC 1+ or greater) in ≥50% of all tumor cells. A new biopsy is required if the sample is over one year.
• ECOG Performance Status 0-1;
• Expected survival greater than 12 weeks;
• Adequate organ and hematopoietic system functions to meet the following requirements:
• Hemoglobin (HGB) s 90 g/L, no blood transfusions within two weeks;
• White blood cell (WBC) count≥2.5×109/L；
• Absolute Neutrophil Count (ANC) ≥1.5×109/L;
• Platelet (PLT) count ≥80×109/L;
• Total bilirubin (TBIL) ≤3.0ng/dL or ≤5 ULN;
• ALT and AST ≤5 ULN; for liver metastasis, ALT and AST ≤5 ULN
• Creatinine (Cr) ≤1.5 x ULN; or creatinine removal rate (CrCl) ≥50 mL/min;

You may not qualify if:

• Females with pregnancy or in lactation period;
• Subjects with active hepatitis B, or active hepatitis C. Subjects with undetectable HBV DNA or HCV RNA after anti-virus treatment can be enrolled;
• HIV positive;
• Other active infections of clinical significance;
• Subjects with the following previous or accompanying diseases:
• Subjects diagnosed as severe autoimmune diseases that require long term (more than 2 months) treatment with systemic immunosuppressants (steroids), or diseases with immune-mediated symptoms, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), and autoimmune vasculitis (e.g. Wegena granuloma);
• Patients with previous diagnosis as motor neuron disease caused by autoimmunity;
• Patients previously suffered from toxic epidermal necrolysis (TEN)
• Patients with any mental illness, including dementia, mental changes, which may cause difficulties understanding the informed consent and related questionnaires;
• Patients with serious uncontrollable diseases, which may interfere with the therapies in this study;
• Patients with other active malignancies in the past 5 years excluding those with completely cured basal or squamous skin cancers, superficial bladder cancers or primary breast cancers without need of follow-up treatment;
• Subjects receiving systemic steroids or steroid inhalants;
• Patients who have received tumor immunotherapy (including monoclonal antibody against PD-1, PD-L1, PD-L2, CD137 or CTLA-4, or cell therapy) in the past 4 weeks;
• Subjects allergic to immunotherapies or related drugs;
• Patients with metastatic lesions in meninges or central nervous system, or clear evidence of central nervous system diseases with continuous significant symptoms in the last 6 months;

Sponsors & Collaborators

• Shanghai PerHum Therapeutics Co., Ltd.: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

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: November 10, 2021
• First Posted: November 22, 2021
• Study Start: December 30, 2021
• Primary Completion: August 15, 2024
• Study Completion: October 24, 2024
• Last Updated: October 28, 2024

Record last verified: 2023-04

Locations

CN (1)