Phase 2 Lymphoma Trial, Recruiting NCT05934513 Sponsor: Genfleet Therapeutics (Shanghai) Inc. Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT05934513
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 to 75 years old
  • People who have given written agreement to take part before any screening tests begin
  • People diagnosed with a type of blood cancer called peripheral T-cell lymphoma that has come back or stopped responding to treatment, confirmed by a tissue test
  • People who have already tried at least 2 but no more than 5 previous cancer treatments that did not work
  • People who have at least one lymphoma lesion (affected area) that can be measured on a scan, based on standard medical guidelines
  • People for whom a fresh or previously collected tumour tissue sample is confirmed to be available at the time of screening
  • People who are reasonably able to carry out daily activities, based on a standard medical performance scale scored 0 to 2 (confirm with trial site)
  • People whose blood counts and organ function meet required levels at screening
  • People with a life expectancy of at least 12 weeks
  • People who have largely recovered from side effects of previous cancer treatments, with the exception of hair loss, tiredness, or mild nerve-related symptoms
  • Women who could become pregnant must agree to use highly effective contraception during the study treatment and for 90 days after the last dose
  • Men whose partner could become pregnant must agree to use highly effective contraception during the study treatment and for 90 days after the last dose

Who may not be able to join:

  • People diagnosed with cutaneous T-cell lymphoma (a type that primarily affects the skin)
  • People with cancer that has spread to the brain or spinal cord and is causing symptoms
  • People with a severe condition called hemophagocytic syndrome at the time of screening (confirm with trial site)
  • People with uncontrolled fluid build-up in body cavities such as the chest or abdomen
  • People who have had chemotherapy, radiotherapy, or certain traditional Chinese anti-cancer medicines within 2 weeks before starting the study drug; major surgery within 4 weeks; certain targeted cancer therapies within 4 weeks or a specified shorter period; or any recent immunotherapy
  • People who have had a donor stem cell transplant, or their own stem cell transplant within 90 days before screening
  • People currently participating in another clinical trial within 2 weeks before starting the study drug
  • People who have previously been treated with a type of drug called a CDK9 inhibitor
  • People who have had another cancer within the past 5 years
  • People with uncontrolled lung scarring, active lung disease, or inflammatory lung conditions
  • People with serious heart or cardiovascular disease
  • People considered at high risk of bleeding in the digestive system
  • People with infections that are not under control
  • People taking steroid medication (such as prednisone) at a dose greater than 20 mg per day for more than 14 days continuously
  • People taking certain medications that strongly affect how the body processes drugs (known as strong CYP3A4 inhibitors or inducers) within 7 days before the first dose; this also includes consuming Seville oranges, grapefruit, pomelos, star citrus fruits, or St. John's Wort within 7 days of the first dose
  • People who have had major surgery within 4 weeks before joining, or who have surgery planned in the near future
  • People who are pregnant or breastfeeding
  • People with any other uncontrolled illness or condition that the trial doctor believes could put them at risk

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86 21 6882 1388

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Genfleet Therapeutics (Shanghai) Inc.
Registry
ClinicalTrials.gov
Start date
6 September 2023
Est. completion
30 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Phase Ib: adverse events; Phase II: Objective Response Rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov