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SARPhase 1NCT05128786

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

A Phase 1 study testing CCT301-38 in people with SAR, run by Shanghai PerHum Therapeutics Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
SAR
What is being tested?
CCT301-38
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
30 Dec 2021to 24 Oct 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;
  • PT: INR < 1.7 or extended PT to normal value < 4s
  • Normal language, recognition and consciousness assessed by investigator during screening phase;
  • Capable of receiving treatment and follow-up, including treatment in the clinical center;

Who cannot join

  • 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);
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  • 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;
  • Patients with NYHA class II heart failure, or hypertension incontrollable by standard care, or medical history of myocarditis, or heart attack within a year;
  • Subjects who have received or are going to receive organ transplantation;
  • Patients with active bleeding;
  • Patients with incontrollable pleural or abdominal fluid that needs clinical treatment or intervention;
  • Patients as determined by the investigators to be inappropriate for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Phase I Trial to Assess Safety, Tolerability and Anti-tumor Activity of Autologous T Cell Modified Chimeric Antigen Receptor (CAR) (CCT301-38) in Patients With Relapsed or Refractory AXL Positive Sarcomas

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

Read the detailed description

This study is an open label, single-center Phase I dose escalation trial to assess the safety, tolerability, DLT and MTD of CCT301-38 cell therapy in patients with AXL positive relapsed or refractory sarcomas.

Subjects that meet inclusion criteria with positive AXL biopsy (IHC 1+ or greater in ≥50% tumor cells) will receive CCT301-38 according to the 3+3 dose escalation design.

Conditions
SAR
Being tested
CCT301-38
Keywords
AXL, CAR-T, CCT301-38, sarcoma, CAR-T, CCT301-38, sarcoma
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CCT301-38Biological

    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.

Study groups in NCT05128786
Study groupRoleWhat they receive
CCT301-38ExperimentalTo determine the safety, tolerability, DLT and MTD of CCT301-38 cell therapy in patients with AXL-positive relapsed or refractory sarcomas.
Receives: Biological: CCT301-38

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 28 days following infusion

Secondary outcomes (7)

  1. ORR

    Proportion of subjects with the best overall response (BOR) of subjects with PR (partial response) and CR (complete response) as determined by local investigator using RECIST 1.1

    Measured: Up to 52 weeks

  2. DCR

    Disease control rate: The proportion of subjects with CR (complete response), PR (partial response) or SD (stable disease lasting over 6 months) as determined by local investigator using RECIST 1.1.

    Measured: Up to 52 weeks

  3. DOR

    Duration of response: The duration of time from record of response to first progression of disease as determined by RECIST 1.1 or death date not relevant to disease progression.

    Measured: Up to 52 weeks

  4. PFS

    Progression free survival: The time of disease progression by RECIST 1.1 or death since cell infusion.

    Measured: Up to 52 weeks

  5. TEAE

    Number, severity and duration of treatment of emergent adverse events (TEAEs) that occur during treatment according to NCI-CTCAE v 5.0.

    Measured: Up to 52 weeks

  6. PK

    The % of patients with detectable CCT301-38 cells in peripheral blood. [Time Frame: Up to 52 weeks]

    Measured: Up to 52 weeks

  7. Biomarker

    To evaluate the correlation of AXL biopsy score to ORR. [Time Frame: Up to 52 weeks]

    Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2021
  2. Study start30 Dec 2021
  3. Primary completion15 Aug 2024
  4. Study completion24 Oct 2024

Why it stopped: Adjustment of study strategy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128786
Sponsor's protocol ID
CCT301-38-SAR
Status last verified
Apr 2023
First submitted
10 Nov 2021
Last updated
28 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CCT301-38 in people with SAR, run by Shanghai PerHum Therapeutics Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Adjustment of study strategy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: 28 days following infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05128786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.

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