Phase 1 Lymphoma Trial, Recruiting NCT06462365 Sponsor: Tr1X, Inc. Condition: Lymphoma
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Phase 1 Lymphoma Trial, Recruiting

NCT06462365
Recruiting Phase 1

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:

  • People diagnosed with one of the following blood cancers: Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), or Chronic Myelomonocytic Leukemia (CMML)
  • Adults aged 18 years or older
  • People weighing at least 35 kg (approximately 77 lbs)
  • People with a general health and activity level meeting a minimum threshold score on the Karnofsky scale (a medical measure of physical functioning) of 70% or above — (confirm with trial site)
  • People who have a partially matched related donor (such as a parent, child, or sibling) or an unrelated donor available to donate blood stem cells
  • People who otherwise meet the transplant centre's own standards for receiving a stem cell transplant from a donor
  • People who have no active, uncontrolled bacterial, viral, or fungal infections at the time of joining the trial
  • People whose heart, liver, kidneys, and other organs are functioning at an adequate level
  • People over 65 years old who are planned to receive intensive (full-strength) conditioning treatment must have a transplant-specific health score below 5 on the HSCT Comorbidity Index (confirm with trial site)
  • People who are able to understand and sign the consent form and are willing to attend all required visits and complete all required procedures

Who may not be able to join:

  • People who have previously received a bone marrow, blood stem cell, or cord blood transplant from a donor
  • People with a history of significant kidney, liver, lung, or heart problems, or who are currently receiving treatment to support heart function
  • People who are HIV positive
  • People who test positive for the Hepatitis B surface antigen, unless a more specific test (HBV PCR) confirms no active virus is present
  • People who test positive for Hepatitis C antibodies with a confirming positive test result, unless they have completed curative antiviral treatment and a follow-up test confirms the virus is no longer detectable
  • People who have received another experimental treatment for the same condition within 28 days (or within 5 half-lives of that treatment, whichever is shorter) before starting the conditioning process, or who have not yet recovered from side effects of that prior treatment
  • People with a past history of a blood clotting disorder called Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS) who are considered unsuitable for treatment with a medication called sirolimus
  • People who are pregnant, currently breastfeeding, or planning to become pregnant during the study period (participants must agree to use a highly effective form of contraception)
  • People with any other serious or uncontrolled illness, psychiatric condition, active infection, or other significant medical or laboratory findings that could affect their participation (confirm with trial site)

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 8 July 2026
Phase 1: approximately ~10% 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

Principal Investigator: Maria Grazia Roncarolo, MD, Tr1X, Inc.

Phone: 858-283-7879

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 1
Sponsor
Tr1X, Inc.
Registry
ClinicalTrials.gov
Start date
8 April 2024
Est. completion
15 April 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and tolerability of TRX103 cell infusion through incidence of Adverse events.; Safety of TRX103 determined by stem cell engraftment and donor chimerism after HSCT measured by absolute neutrophil counts and percent donor chimerism.; Safety of TRX103 determined by negative Replication Competent Lentivirus (RCL).

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: 8 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