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Solid TumorPhase 1NCT04511871

A Phase I Trial of CCT303-406 in Patients With Relapsed or Refractory HER2 Positive Solid Tumors

A Phase 1 study testing CCT303-406 in people with Solid Tumor and Gastric Cancer, run by Shanghai PerHum Therapeutics Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This clinical study is to investigate the safety and tolerability of CCT303-406 CAR modified autologous T cells (CCT303-406) in subjects with relapsed or refractory stage IV metastatic HER2-positive solid tumors. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Solid Tumor, Gastric Cancer, Breast Cancer
What is being tested?
CCT303-406
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
9 Jul 2020to 29 Mar 2025
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 stage IV (according to the 8th edition of AJCC) advanced solid tumor malignancies that have failed standard treatment of relapsed or difficult-to-treat solid tumors 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
  • Tumors with HER2 IHC 3+ in≥50% of all tumor cells as determined by IHC according to the Breast Cancer HER2 Testing (2019 edition) and the Gastric Cancer HER2 Testing (2016 edition); For HER2 IHC 3+ tumors other than gastric and breast cancers, FISH is required to confirm HER2 expression; For relapsed patients after HER2-targeted therapies, biopsy and IHC are required to confirm HER2 expression per enrollment criteria.
  • 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 x 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
  • LVEF≥50%
  • Serum troponin T <0.03 ng/mL
  • 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;
  • Female subjects of childbearing age must take acceptable measures to minimize the likelihood of pregnancy during the trial. The results of serum or urine pregnancy test must be negative
  • Female subjects must not be in the lactation period.

Who cannot join

  • Females with pregnancy or in lactation period
  • Patients with active hepatitis B, or active hepatitis C
  • HIV positive
  • Other active infections of clinical significance
  • Patients receiving in situ surgery within 3 months
  • Patients with the following previous or accompanying diseases:
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  • Patients 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
  • Patients with ≥Grade 2 peripheral neuronal diseases (according to NCI-CTCAE v5.0)
  • 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
  • Patients receiving systemic steroids or steroid inhalants
  • Patients who have received tumor immunotherapy (including monoclonal antibody or cell therapy) in the past 4 weeks
  • Patients 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 continous 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
  • Patients 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 having undergone major surgery within 4 weeks or have not fully recovered from prior surgery
  • Patients that have received radiotherapy within 4 weeks, excluding those who received local irradiation for the peripheral bone metastatic lesions for more than 2 weeks, and recovered from all acute toxicities of radiotherapy
  • Patients that have received anthracyclines within 8 weeks
  • 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) (CCT303-406) in Patients With Relapsed or Refractory HER2 Positive Solid Tumors

This clinical study is to investigate the safety and tolerability of CCT303-406 CAR modified autologous T cells (CCT303-406) in subjects with relapsed or refractory stage IV metastatic HER2-positive solid tumors.

Read the detailed description

This is a single arm, open label, dose escalation clinical study to evaluate the safety and preliminary therapeutic efficacy of CCT303-406 cells in adult subjects with HER2 positive relapsed or refractory stage IV metastatic solid tumors.

Subjects that meet inclusion criteria with positive biopsy HER2 (IHC 3+ in ≥50% tumor cells) will receive CCT303-406 according to the 3+3 dose escalation design.

Being tested
CCT303-406
Keywords
HER2, CAR-T, Solid tumors
Medical subject headings
Stomach Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Sarcoma

What participants receive

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

  • CCT303-406Biological

    Blood will be collected from subjects to isolate peripheral blood mononuclear cells for the production of CCT303-406. Subjects will receive the conditioning chemotherapy regimen of cyclophosphamide and fludarabine for lymphodepletion followed by a single dose of CCT303-406 via intravenous injection.

Study groups in NCT04511871
Study groupRoleWhat they receive
CCT303-406ExperimentalTo determine the safety, tolerability, dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of CCT303-406 cell therapy in patients with HER2-positive (IHC 3+ in ≥50% tumor cells) relapsed or refractory solid tumors. Dose cohorts: * Dose 1: 3x10^5 CCT303-406 CAR-positive T cells/kg body weight, intravenous infusion * Dose 2: 1x10^6 CCT303-406 CAR-positive T cells/kg body weight, intravenous infusion * Dose 3: 1x10^7 CCT303-406 CAR-positive T cells/kg body weight, intravenous infusion
Receives: Biological: CCT303-406

What is being measured

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

  1. MTD: to determine the maximum tolerated dose of CCT303-406

    To assess the DLT (dose limiting toxicities) attributed to CCT303-406 per cohort and determine the RP2D (recommended phase 2 dose).

    Measured: 28 days following infusion

Secondary outcomes (8)

  1. ORR (overall response rate): Proportion of subjects with the best overall response (BOR)

    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. 12 month survival rate

    The proportion of living subjects within 52 weeks of infusion

    Measured: Up to 52 weeks

  3. 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

  4. DOR: Duration of reponse

    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

  5. PFS: Progression free survival

    The time of disease progression by RECIST 1.1 or death since cell infusion

    Measured: Up to 52 weeks

  6. AE: Adverse Events

    The incidence, severity and duration of AE, TEAE and SAE as determined by NCI-CTCAE v5.0

    Measured: Up to 52 weeks

  7. The expansion over time of genetically modified CCT303-406 cells in the peripheral blood as determined by QPCR (copies/ug gDNA)

    PK: Pharmacokinetics

    Measured: Up to 52 weeks

  8. The persistence over time of genetically modified CCT303-406 cells in the peripheral blood as determined by Flow Cytometry (% CAR + cells)

    PK: Pharmacokinetics

    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 posted13 Aug 2020
  2. Study start9 Jul 2020
  3. Primary completion24 Oct 2024
  4. Study completion29 Mar 2025 (estimated)

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04511871
Sponsor's protocol ID
CCT303-406-mST01
Status last verified
Oct 2024
First submitted
10 Aug 2020
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 CCT303-406 in people with Solid Tumor and Gastric Cancer, 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 22 inclusion and 23 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: status not confirmed, 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?

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?

MTD: to determine the maximum tolerated dose of CCT303-406 (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 NCT04511871.

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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