Autologous Tumor Infiltrating Lymphocyte (TIL) GT201 Infusion.

ConditionAdvanced Solid Tumors Cancer

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorGritbio Medicine, Inc.

About this trial

This is a multicenter, single-arm phase 1/2 clinical trial to evaluate the safety and tolerability of GT201 as a monotherapy or in combination with anti-PD-1 therapy in patients with advanced solid tumors, and to evaluate the efficacy of this therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1 Age 18~70 years old;

2 Diagnosed with: Phase 1 part: Patients with advanced solid tumors who have failed all standard therapy, have no standard therapy, or are intolerant of standard therapy Phase 2a part: Patients with an advanced or metastatic solid tumor enrolled in one of three (3) indications selected for dose expansion based on Phase 1 safety and preliminary activity. Patients must have progressed on or after standard-of-care therapy, or for whom no suitable standard therapy is available;

3 At least one lesion that is resectable for the preparation of autologous TIL cells;

4 At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling;

Disqualifiers

1 Patients with spinal cord compression that has failed to resolve after surgery and/or radiotherapy (patients with clinical evidence that symptoms have resolved after surgery or radiation therapy for ≥ 1 week prior to surgical sampling are eligible for enrollment);

2 Bleeding events within 3 months prior to screening

3 Patients with arterio-venous thrombotic events that occurred within 3 months prior to screening

4 Have interstitial pneumonia or active pneumonia that is clinically significant at screening, or other respiratory conditions that severely affect lung function;

Trial design

Design model

Single group

Treatments tested in this trial

GT201
Biological/Vaccine
A tumor sample from individual participant is collected through a surgical resection for ex vivo manufacturing of GT201 TIL cell product.
IL-2 and PD-1
Biological/Vaccine
Participants tandemly receives a lymphodepleting regimen, GT201 TIL product, and IL-2. Some participants may also receive a PD-1 inhibitor following GT201 infusion

Treatment groups

63 Participants

are divided into 1 treatment group

Group A: Participants with advanced solid tumorsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors

Incidence and severity of AEs will be graded per NCICTCAE v5.0 (Phase 1)

Time frame

Upto 2 years

To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors

Incidence and severity of CRS and ICANS AE's will be graded per the ASTCT criteria (Phase 1)

Time frame

Upto 2 years

To assess the tolerance of GT201 and decide on the recommended Phase 2 dose.

The safest combination will be used to determine recommended dose for Phase 2 (RP2D) (Phase 1)

Time frame

Upto 2 years

To assess the Objective Response Rate (ORR) of GT201 infusion in accordance with RECIST v1.1

To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) (Phase 2)

Time frame

Upto 2 years

Secondary outcomes

To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: Objective response rate (ORR)

Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) per RECIST v1.1 (Phase 1 and Phase 2)

Time frame

Upto 2 years

To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: duration of response (DOR)

The duration from the first confirmed objective response per RECIST v1.1 to the first documentation of progressive disease (PD) or death from any cause (Phase 1 and Phase 2)

Time frame

Upto 2 years

To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: disease control rate (DCR)

Proportion of participants achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1 (Phase 1 and Phase 2).

Time frame

Upto 2 years

To assess efficacy of GT201 in the treatment of recurrent or metastatic solid tumors: progression free survival (PFS)

The time from GT201 infusion to the first documentation of progressive disease (PD) per RECIST v1.1 or death from any cause, whichever occurs first (Phase 1 and Phase 2)

Time frame

Upto 2 years

Other outcomes

Evaluate the persistence of GT201 cells in the treatment of recurrent or metastatic solid tumors

Conduct product related TCR clones by TCR repertoire analysis on peripheral blood (Phase 1 and Phase 2)

Time frame

Upto 2 years

Locations

This trial has no locations.

Sponsors and contacts

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

Gritbio Medicine, Inc.

Lead sponsor

Source ClinicalTrials.gov

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