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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06514794




Registration number
NCT06514794
Ethics application status
Date submitted
17/07/2024
Date registered
23/07/2024
Date last updated
10/02/2025

Titles & IDs
Public title
A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy inT-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Scientific title
A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)
Secondary ID [1] 0 0
WUC007-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
T-cell Acute Lymphoblastic Leukemia 0 0
Lymphoblastic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - WU-CART-007

Experimental: WU-CART-007 - A CD7-directed chimeric antigen receptor (CAR) T-cell product.

A single IV infusion of WU-CART-007 Cells on Day 1 after Lymphodepletion(LD) Therapy.


Treatment: Other: WU-CART-007
A single IV infusion of WU-CART-007 cells on Day 1
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
R/R Cohort - Composite Complete Response Rate
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
MRD Pos Cohort - Response Rate
Timepoint [2] 0 0
24 months
Secondary outcome [1] 0 0
Objective Response Rate
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
MRD Response Rate (R/R Cohort)
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Hematopoietic Stem Cell Transplant (HSCT) rate
Timepoint [5] 0 0
24 months

Eligibility
Key inclusion criteria
Key

* Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive, defined as:

* Relapsed or Refractory Cohort: disease defined by bone marrow with =5% lymphoblasts by morphologic assessment or flow cytometry or evidence of extramedullary disease (EMD). Patients must also be characterized by at least one of the following criteria:

* Primary refractory: failure to achieve remission after bona fide induction attempt which may include consolidation.
* Early Relapse: relapsed disease within 24 months of initial diagnosis.
* Late Relapse (relapsed refractory disease): relapsed disease after 24 months of initial diagnosis AND failure of re- induction therapy after disease recurrence.
* Relapsed or refractory disease after allogeneic transplant,
* Minimal Residual Disease (MRD) Cohort: evidence of MRD, defined as < 5% blasts in bone marrow but = 0.01% blasts determined by central laboratory flow cytometry assay, and characterized by at least one of the following criteria:

* Failure to reach MRD negative status following induction and consolidation in frontline therapy or reinduction for relapse.
* MRD positive disease following allogeneic HSCT.
* Adequate Organ Function as defined as:

* Hepatic and renal function:

* Hepatic transaminase (both alanine aminotransferase and aspartate aminotransferase) levels =5 times the institutional upper limit of normal (ULN),
* Total bilirubin level =1.5 times the ULN (unless the patient has a history of Gilbert's Syndrome, in which case, total bilirubin must be =2.5 times the ULN),
* Serum creatinine level =1.5 times the ULN or a calculated or measured creatinine clearance of =50 ml/min.
* Respiratory function: Must have a minimum level of pulmonary reserve defined as pulse oxygenation >91% on room air.
* Cardiovascular function: left ventricular ejection fraction =45% for adults or shortening fraction = 28% for pediatric patients confirmed by echocardiogram or MUGA within 28 days of Screening.
* Age: Lower age limit of = 1 year.
* Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/60 and above at Screening (Adults age > 16) or Lansky Performance Status 60 and above (pediatrics/ adolescents age =16).
* Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent. For minors, legal guardian willingness to give written informed consent with patient assent, where appropriate.
* Willing to participate in WUC007-02 for long term follow-up.
Minimum age
12 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who meet any of the following criteria will be excluded from study entry:

* Treatment with any prior anti-CD7 therapy.
* Unresolved toxicities from prior anticancer therapy, defined as having not resolved to baseline or to CTCAE Grade =1, except for nausea or alopecia, or to the levels dictated in the inclusion/exclusion criteria.
* Patients with hypersensitivity to cyclophosphamide or fludarabine, their excipients, or cyclophosphamide metabolites.
* Patients with urinary outflow obstruction and acute urothelial toxicity from prior chemotherapy or radiation.
* Patients with decompensated hemolytic anemia.
* Active or latent hepatitis B or active hepatitis C, or any uncontrolled infection
* HIV positive test within 8 weeks of planned treatment initiation.
* Serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
* Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression (e.g. steroids). Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.
* Presence of other active cancers, or history of treatment for invasive cancer =3 years.
* Patients with active central nervous system (CNS) leukemia involvement defined as CNS-3 are not eligible unless CNS leukemia is reduced to CNS2 or CNS1.
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
* Pregnant or nursing (lactating) women.
* Patient with rapidly progressive disease that in the opinion of the investigator may put the patient at increased risk of toxicities.
* Requires prohibited medication or treatments e.g. steroids, or anti-neoplastic agents.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2028
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter Mac Callum Cancer Institute - Melbourne
Recruitment hospital [2] 0 0
Royal Children's Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wugen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to evaluate the Composite Complete Remission Rate (CRc) of WU-CART-007 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) patients and to evaluate the efficacy of WU-CART-007 to induce complete Minimum Residual Disease (MRD) negative response
Trial website
https://clinicaltrials.gov/study/NCT06514794
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cherry Thomas, MD
Address 0 0
Wugen, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eileen McNulty
Address 0 0
Country 0 0
Phone 0 0
636-385-5306
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06514794