RecruitingPhase 1

Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma

United States33 participantsStarted 2025-04-29

Plain-language summary

This will be a Phase 1, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with R/R T-ALL or T-LLy. BEAM-201 is an allogeneic anti-CD7 CART therapy.

Who can participate

Age range

0 Years – 29 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Active hepatitis B or active hepatitis C
. Active HTLV infection
. HIV infection
. Uncontrolled, active bacterial, viral, or fungal infection.
. CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
. Clinically active CNS dysfunction or known history of irreversible central neurological toxicity related to prior antileukemic therapy.
. Receipt of prior CD7 targeted therapy.
. Radiation therapy within 2 weeks prior to completion of screening, other than prophylaxis for CNS disease.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine the Maximum Tolerate Dose of Beam 201 Cells

Timeframe: 5 years

Frequency of Adverse Events Following Beam-201 administration

Timeframe: 5 years

Trial details

NCT IDNCT06934382

SponsorStephan Grupp MD PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-05-30

Contact for this trial

Cell Therapy Intake Team

445-942-5891 CARTNurseNavigator@chop.edu

View on ClinicalTrials.gov More T-Cell Acute Lymphoblastic Leukemia/Lymphoma trials