CompletedPhase 1

A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

United States28 participantsStarted 2022-01-14

Plain-language summary

The purpose of this study is to evaluate the safety, recommended dose, and preliminary anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).

Who can participate

Age range12 Years

SexALL

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

Key Eligibility Criteria: * Diagnosed relapsed or refractory T-ALL or T-LBL, as defined by World Health Organization (WHO) classification * Adequate renal, hepatic, respiratory, and cardiovascular function * Life expectancy \>12 weeks * ECOG/Karnofsky performance status 0 or 1 at screening (Adults age \>16) or Lansky Performance Status 60 and above (adolescents ≤ 16),

What they're measuring

Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5

Timeframe: 24 months

Maximum Tolerated Dose (MTD)

Timeframe: up to 28 days from first dose

Trial details

NCT IDNCT04984356

SponsorWugen, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-08

View on ClinicalTrials.gov More T-cell Acute Lymphoblastic Leukemia trials