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Advanced Malignant Solid TumorsPhase 1NCT06728189

A Clinical Research About CD70-targeted CAR-NKT Cells Therapy in Subjects with Advanced Malignant Solid Tumors

A Phase 1 study testing CAR-NKT Cells treatment in people with Advanced Malignant Solid Tumors, run by Peking University Cancer Hospital & Institute at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced malignant solid tumors. Condition or disease：advanced malignant solid tumors Intervention/treatment：Biological: CD70 CAR-NKT cells Phase：Phase 1 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Solid Tumors
What is being tested?
CAR-NKT Cells treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteChina
Study dates
14 Nov 2024to 17 Oct 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 75 years.
  • ECOG 0-1 points.
  • The expected survival time is more than 3 months.
  • Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
  • IHC: CD70 positive.
  • At least one measurable lesion at baseline per RECIST version 1.1.
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  • The functions of important organs are basically normal:
  • Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.
  • Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.

Who cannot join

  • Use of cell therapy within the previous one month.
  • Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.
  • Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.
  • Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
  • Active hepatitis B, HIV positive and HCV positive.
  • Active infection or uncontrollable infection.
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  • Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standard therapy requiring special treatment, previous history of myocarditis, or myocardial infarction within 6 months.
  • Unstable respiratory diseases, including interstitial pneumonia.
  • Uncontrolled ascites and pleural effusion
  • Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .
  • Subjects who are using systemic steroids or steroid inhalers for treatment.
  • Pregnant or lactating female subjects.
  • Other investigators deem it unsuitable to participate in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xinan Sheng Professor, MD contact

+86-10-88196348

doctor_sheng@126.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing

    Xinan Sheng, Professor, 86-13810335676, doctor_sheng@126.com

    Recruiting

Other trials in China

About this study

Official title: A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects with Advanced Malignant Solid Tumors

This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced malignant solid tumors.

Condition or disease：advanced malignant solid tumors Intervention/treatment：Biological: CD70 CAR-NKT cells Phase：Phase 1

Read the detailed description

This was a dose-expansion study, we plan to enroll 13 to 23 patients with CD70-positive advanced malignant solid tumors to CGC738 treatment. The study was conducted in two stages: dose escalation and dose expansion. Dose escalation involved three dose groups, which were administered using a rapid titration approach combined with the "3+3" design. Revised sentence: "One subject will be enrolled in the initial dose group, and if no dose-limiting toxicity (DLT) occurs within 28 days of the first administration, three additional subjects will be recruited into the subsequent predetermined escalating dose group. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. Dose exploration can be discontinued once one or more dose levels with an acceptable safety profile and satisfactory antitumor activity have been selected for subsequent evaluation. During the treatment period of the study, three dose levels of CGC738 will be evaluated. Each of the dose levels will evaluate the safety of the CAR-NKT cells.

The extended study is anticipated to enroll a cohort of 6 to 10 participants. We used leukapheresis for cell collection. The lymphodepletion procedure was conducted using a combination of fludarabine and cyclophosphamide.

Being tested
CAR-NKT Cells treatment

What participants receive

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

  • CAR-NKT Cells treatmentBiological

    Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells Lymphodepleting regimen, Cyclophosphamide 250mg/m2 IV on day -5 to -3 and Fludarabine 25mg/m2 IV on days -5 to -3. Followed by infusion of CAR-NKT on day 0.

    Potential CGC738 doses:

    Dose level 1: 5.0×106 CAR- NKT cells/m2; Dose level 2: 1.5×107 CAR- NKT cells/m2; Dose level 3: 4.5×107 CAR- NKT cells/m2;

Study groups in NCT06728189
Study groupRoleWhat they receive
CAR-NKT Cells Lymphodepleting regimenExperimentalCyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells Lymphodepleting regimen, Cyclophosphamide 250mg/m2 IV on day -5 to -3 and Fludarabine 25mg/m2 IV on days -5 to -3. Followed by infusion of CAR-NKT on day 0.
Receives: Biological: CAR-NKT Cells treatment

What is being measured

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

  1. Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)

    Dose limiting toxicity (DLT) is an AE that meets the following criteria and occurs within 28 days of CGC729 infusion.AE is graded according to CTCAE version 5.0.

    Measured: Day 28 after CGC738 infusion

Secondary outcomes (4)

  1. Assess Objective response rate (ORR)

    Measured: Day 1 through week 56

  2. Assess Disease control rate (DCR)

    Measured: Day 1 through week 56

  3. Incidence of adverse events (AEs)

    Measured: Day 1 through week 56

  4. Cmax, Tmax, AUCS of CD70 CAR-NKT cell dynamics

    Measured: Day 1 through week 56

Timeline

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

  1. First posted11 Dec 2024
  2. Study start14 Nov 2024
  3. Primary completion17 Oct 2026 (estimated)
  4. Study completion17 Oct 2026 (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
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06728189
Sponsor's protocol ID
CGC738-IIT-01
Status last verified
Dec 2024
First submitted
22 Nov 2024
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAR-NKT Cells treatment in people with Advanced Malignant Solid Tumors, run by Peking University Cancer Hospital & Institute 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 11 Dec 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Xinan Sheng Professor, MD (+86-10-88196348, doctor_sheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) (time frame: Day 28 after CGC738 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 NCT06728189.

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 11 Dec 2024.

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