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A Clinical Research of CD70-targeted CAR-NKT Cells (CGC738) Therapy in RCC

ConditionAdvanced Clear Cell Renal Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenJi Hospital

About this trial

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 clear cell renal cell carcinoma (ccRCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age 18 to 75 years.

2.ECOG 0-1 points.

3. The expected survival time is more than 3 months.

4. Patients with advanced ccRCC confirmed by histology or cytology to be recurrent or metastatic after at least first-line treatment.

Disqualifiers

1. Use of cell therapy within the previous one month.

2. 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.

3. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.

4. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.

Trial design

Design model

Single group

Treatments tested in this trial

  • CGC738

    Drug

    CAR-NKT Cells treatment

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: CAR-NKT Cells Lymphodepleting regimenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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 CGC738 infusion.AE is graded according to CTCAE version 5.0.

Time frame
Day 28 after CGC738 infusion

Secondary outcomes

1

ORR

Assess Objective response rate

Time frame
Day 1 through week 56
2

DCR

Assess Disease control rate

Time frame
Day 1 through week 56
3

AEs

Incidence of adverse events

Time frame
Day 1 through week 56

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: