BridgeMD
Tests treatment safety and results for Lymphoma, T-Cell
Official title Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R/R NK and T-cell Malignancies
ClinicalTrials.gov ID: NCT06699771
What this study is testing
What is GCC2005?
GCC2005 is an investigational medicine, being studied as a potential treatment for lymphoma, t-cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1 (a and b), first in human (FIH), single-arm, open-label, multicenter study to evaluate the safety, tolerability and efficacy of GCC2005 in the treatment of patients with relapsed/refractory (R/R) NK or T-cell malignancies who have received at least two prior lines of therapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join if
- Participants with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).
- Participants with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any...
- According to the Lugano classification, Participants having lesion/nodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0...
- Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Participants who satisfy the criteria defined in the protocol.
You likely can't join if
- Has T-ALL/T-LBL, CTCL or ALCL.
- Participants with CNS lymphoma or any involvement of the CNS.
- Participants who had a prior history of another malignancy over the last 3 years.
- Participants who have used hematopoietic growth factor therapy within 14 days prior to Screening.
- Participants who have had prior CAR-T or CAR-NK therapies.
- Presence of uncontrolled fungal, bacterial, viral infection or other infection requiring IV antimicrobials for management
See the full eligibility criteria
- Participants with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).
- Participants with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment option considered as assessed by the Investigator.
- According to the Lugano classification, Participants having lesion/nodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0 cm for extranodal lesions, and the boundaries are clearly shown.
- Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Participants who satisfy the criteria defined in the protocol.
- Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participants who comply with all procedures of this study and voluntarily give written consent
- Has T-ALL/T-LBL, CTCL or ALCL.
- Participants with CNS lymphoma or any involvement of the CNS.
- Participants who had a prior history of another malignancy over the last 3 years.
- Participants who have used hematopoietic growth factor therapy within 14 days prior to Screening.
- Participants who have had prior CAR-T or CAR-NK therapies.
- Presence of uncontrolled fungal, bacterial, viral infection or other infection requiring IV antimicrobials for management
- Participants with previous allogenic organ transplantation
- Participants with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency.
- Participants with acute GvHD ≥ Grade 3 or extensive chronic GvHD within 2 weeks of lymphodepletion.
- Participants with known active Hepatitis B or C
- Participants with presence of Grade 2 or greater toxicity from the previous treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.