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RecruitingLast updated: 26 August 2022

WUCART: This phase I/II study is evaluating the safety, recommended dose level, and effectiveness of a new treatment (WU-CART-007) in people with relapsed or refractory T-cell acute lymphoblastic leukaemia or lymphoblastic lymphomaA Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

Clinical summary

Summary

This study consists of two phases. In Phase 1 (Dose Escalation), up to 24 participants will be treated with 2 dose of WU-CART-007, in up to 4 dose levels, until the maximum tolerated dose (MTD) or maximum administered dose (MAD) is determined. Once the recommended phase 2 dose (RP2D) is defined, the Phase 2 portion (Cohort Expansion) will enrol expansion cohorts. WU-CART-007 will be administered via single intravenous (IV) infusion on Day 1 after Lymphodepletion (LD) Therapy. Cyclophosphamide 500mg/m2/day x 3 (days -5 to -3) Fludarabine 30mg/m2/day x 3 (days -5 to -3).

Conditions

This trial is treating patients with relapsed or refractory T-cell acute lymphoblastic leukaemia or lymphoblastic lymphoma.

Cancer

Blood Cancers Blood

Age

People12+

Phase

I/II

Trial Acronym

WUCART

More information

Trial Identifiers

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Commercial Sponsor

Wugen, Inc.

Scientific Title

A Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

Eligibility

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

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Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.