Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing TSLPR-CART for B-All

Background: B-cell acute lymphoblastic leukemia (B-ALL) is a type of blood cancer. Some people with B-ALL have a gene mutation that makes the disease hard to treat.

Official registry: https://clinicaltrials.gov/study/NCT07572136 · National Cancer Institute (NCI) · enrollment listed as 57

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TSLPR-CART, Cyclophosphamide, or Fludarabine. The registry lists allocation as na. Background: B-cell acute lymphoblastic leukemia (B-ALL) is a type of blood cancer.

They plan to enroll about 57 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

Phase I Dose Escalation Study of Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-cell Acute Lymphoblastic Leukemia (B-ALL)

Interventions: TSLPR-CART, Cyclophosphamide, Fludarabine

Primary outcome (registry wording): To assess the safety of administering escalating doses of TSLPR-CART containing a tEGFR suicide switch to determine an MTD

Who it is for (from inclusion criteria)

  • Ages 18 Years to 120 Years
  • Documentation of pathologic confirmation of a diagnosis of B-Cell acute lymphoblastic leukemia (ALL)
  • \*Individuals that are CD19 positive will be considered for this study, However, these individuals should be ineligible for, unable to obtain in a timely manner, cannot access, unwilling to undergo, or have failed prior FDA approved CD19 CAR constructs
  • Participants must have measurable or evaluable disease at the screening, defined by any evidence of MRD or positron emission tomography (PET)-avid extramedullary disease
  • Clinical performance status: Karnofsky \>= 50%. Participants who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for the purpose of calculating the performance score
  • Participants must have adequate organ and marrow function as defined below:
  • Leukocytes \>= 750/mcL\*
  • Platelets \>= 50,000/mcL\*

Public study contact (from the registry)

NCI Ped LeukemiaLymph Cell Tx Tm

(240) 760-6970

ncilltct@mail.nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07572136 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07572136?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07572136?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary