Health TrialsbyHealthPanel

RE002 T Cell Injection for the Treatment of KRAS G12D Mutated Solid Tumors

ConditionsKRAS G12DT Cell Therapy
Trial statusRecruiting
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 KRAS mutant tumors in clinic. Preclinical studies support the specificity, safety and anti-tumor activity of RE002. Previous similar studies suggest the feasibility of TCR-T treatment, and measures have been taken to ensure the safe administration of RE002 and the close monitoring and management of adverse events. To sum up, RE002 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

  • RE002 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/m2/days,-5,-4 days) and fludarabine (25-30mg/m2/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: RE002 T cell adoptive immunotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall response rate (ORR).

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

Time frame
24-36 months

Secondary outcomes

1

Duration of response (DOR).

DOR was measured from the first documented partial response until disease progression or death from any cause.

Time frame
24-36 months

Other outcomes

1

Disease control rate (DCR).

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

Time frame
24-36 months
2

Stable disease (DOSD).

DOSD was defined as the time from the first documented stable disease to disease progression.

Time frame
24-36 months
3

Progression-free survival (PFS).

PFS was calculated from the date of T-cell infusion to radiological progression, or death from any cause.

Time frame
24-36 months
4

Overall survival (OS).

OS was defined as the time from T-cell infusion 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
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