Long-term safety follow-up of ARD103 CAR-T cells in relapsed/refractory AML and MDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study tracks safety outcomes for up to 15 years after ARD103 CAR-T therapy. Participants from the parent interventional trial who received partial or full ARD103 dosing enter the follow-up study after completing 24 months or after early discontinuation. No new drug is administered during the follow-up period; safety data are collected continuously, including adverse events and serious adverse events related to ARD103. The study is conducted at three U.S. sites and aims to characterize long-term safety over the extended monitoring period. It is led by ARCE Therapeutics with collaboration from affiliated centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The participant has R/R AML or MDS and has previously received ARD103 CAR-T cell therapies in the parent study.
* The participant is able to understand and comply with protocol-required study procedures and has provided a written informed consent document.

Exclusion Criteria:

* There are no specific exclusion criteria for this study

Where it's running

• Novant Health Cancer Institute
  Charlotte, North Carolina, United States Recruiting
• Novant Health Cancer Institute
  Winston-Salem, North Carolina, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: ARCE Therapeutics, Inc ARCE
• Email: contact@arcetherapeutics.com
• Phone: +886-2-26581868

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment with ARD103 CAR-T therapy for patients with relapsed or refractory AML or MDS

  This study is testing a new CAR-T therapy called ARD103 to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia or myelodysplastic syndrome.

  Recruiting at 3 sites Phase 1/2 ARCE Therapeutics, Inc. · Charlotte, North Carolina and 2 other locations · NCT06680752

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

  This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

  This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

  This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.

  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.