RE001 T Cell Injection for the Treatment of KRAS G12V Mutated Solid Tumors

ConditionsKRAS G12V T Cell Therapy

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorHenan Cancer Hospital

About this trial

At present, there is an urgent need for new drugs for kirsten rat sarcoma viral oncogene (KRAS) mutant tumors in clinic. Preclinical studies support the specificity, safety and anti-tumor activity of RE001. Previous similar studies suggest the feasibility of T cell receptor engineered T cell therapy (TCR-T) treatment, and measures have been taken to ensure the safe administration of RE001 and the close monitoring and management of adverse events. To sum up, RE001 has controllable safety and anti-tumor activity on KRAS mutant solid tumor, which can be preliminarily studied to provide support for clinical research of patients with advanced solid tumor.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects voluntarily participate in the study and sign informed consent;

Age ≥18 years old and ≤75 years old;

Advanced malignant solid tumors with clear pathological diagnosis;

Standard therapies failed or cannot be tolerated or lacks effective treatments;

Disqualifiers

Those who have received major surgery, conventional chemotherapy, large-area radiotherapy, immunotherapy or biological therapy anti-tumor treatment within 4 weeks before entering the trial;

Previous use of drugs targeting KRAS G12V mutations, including previous participation in cell therapy with similar targets Cellular testing and small molecule inhibitors targeting KRAS G12V mutations, etc.;

Allergic reactions are known to occur to any ingredient (such as dimethyl sulfoxide, cyclophosphamide, fludarabine) or structurally similar compounds treated in this trial;

Failure to recover from adverse reactions related to previous surgery or treatment to < Grade 2 CTCAEV5.0;

Trial design

Design model

Single group

Treatments tested in this trial

RE001 T cell
Biological/Vaccine
All subjects who met the entry and exit criteria and signed the informed consent form were observed in hospital at the beginning of lymphocyte clearance chemotherapy, with the dosage of cyclophosphamide (600-800mg/m\^2/days,-5,-4 days) and fludarabine (25-30mg/m\^2/days,-5,-4,-3 days), at least two days after the completion of lymphocyte clearance chemotherapy.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: RE001T cell adoptive immunotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Overall response rate (ORR).

Defined as the proportion of subjects with confirmed CR and PR.

Time frame

24-36 months

Secondary outcomes

Duration of response (DOR).

Defined as the time from cell infusion to disease progression or death in subjects achieving CR or PR.

Time frame

24-36 months

Other outcomes

Disease control rate (DCR).

Defined as the proportion of subjects who achieved CR, PR, and SD after treatment.

Time frame

24-36 months

Stable disease (DOSD).

The definition refers to the period from the start of treatment to the time of evaluation for PD.

Time frame

24-36 months

Progression-free survival (PFS).

Definition refers to the time from the subject's enrollment date (starting treatment date) to the occurrence of PD or death for any reason, whichever occurs first.

Time frame

24-36 months

Overall survival (OS).

Definition refers to the time from the beginning of treatment to death from any cause.

Time frame

24-36 months

Sponsors and contacts

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

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

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