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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04984356




Registration number
NCT04984356
Ethics application status
Date submitted
29/07/2021
Date registered
30/07/2021
Date last updated
24/11/2023

Titles & IDs
Public title
A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL
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)
Secondary ID [1] 0 0
WU-CART-007 1001
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
Other interventions - 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.


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

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD)
Timepoint [2] 0 0
up to 28 days from first dose
Primary outcome [3] 0 0
Composite Complete Response Rate
Timepoint [3] 0 0
24 months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Objective Response Rate
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
Hematopoietic Stem Cell Transplant (HSCT) rate
Timepoint [4] 0 0
24 months

Eligibility
Key inclusion criteria
Key Inclusion/
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Specific inclusion criteria apply to each disease subtype. In general, all patients will
have:

- Evidence of relapsed or refractory T-ALL or T-LBL, as defined by World Health
Organization (WHO) classification with bone marrow with = 5% lymphoblasts by
morphologic assessment or evidence of extramedullary disease at screening.

- Relapsed or refractory disease defined as at least one of the following criteria:

1. Primary refractory: failure to achieve CR after induction chemotherapy, per
investigator.

2. Early Relapse: relapsed disease within 12 months of initial diagnosis.

3. Late Relapse (relapsed refractory disease): relapsed disease after 12 months of
initial diagnosis AND failure of re-induction therapy after disease recurrence.

4. Relapsed or refractory disease after allogeneic transplant, and meet the
following criteria:

i. There must be histological confirmation of relapse after HSCT of T-ALL or T-LBL.

ii. Undergone allogeneic HSCT > 90 days prior to enrollment from a match related or
unrelated donor, cord blood donor, haplo-identical, or autologous stem cells.

iii. Off all immunosuppressive medications for a minimum of 2 weeks with the exception of
physiologic doses of corticosteroids.

iv. No prior history of Grade 2 or greater (per Cairo-Bishop) veno-occlusive disease
(VOD)/sinusoidal obstruction syndrome, or active graft versus host disease (GvHD) (see
exclusion criteria below for exceptions).

- Adequate renal, hepatic, respiratory, and cardiovascular function, as defined in the
body of the protocol.

- Life expectancy >12 weeks

- Age: Lower age limit of 12 years. Adolescent ages 12-17 will be eligible for
enrollment beginning at Dose Level 3 of the Dose Escalation phase, after review of
safety, efficacy and cellular PK data and after consultation with the appropriate
regulatory agencies.

- ECOG/Karnofsky performance status 0 or 1 at screening (Adults age >16) or Lansky
Performance Status 60 and above (adolescents = 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 WUC-007-02 for long-term follow up.

Patients will be excluded from study entry if:

- They have received previous treatment with any prior anti-CD7 therapy.

- Have not recovered from the effects of previous therapy.

- Wash-out period of at least 5 half-lives from the last dose of any investigational
therapy prior to screening period and all related toxicities resolved to Grade 1 or
baseline.

- Have active or latent hepatitis B or active hepatitis C, any uncontrolled infection,
or untreated HIV positive.

- Have any serious active infection at the time of treatment, or another serious
underlying medical condition that would impair the ability of the patient to receive
protocol treatment.

- Have Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression
(steroids). Grade 1 GvHD not requiring immunosuppression is acceptable and grade 2
skin GvHD if treated with topical therapy only is acceptable.

- Have psychological, familial, sociological, or geographical conditions that do not
permit compliance with the protocol.

- Pregnant or nursing (lactating) women

- Require prohibited medications or treatments, eg, steroids, or anti-neoplastic agents

- Treated with anti-T cell monoclonal antibodies

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- 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
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
Netherlands
State/province [8] 0 0
Rotterdam
Country [9] 0 0
Netherlands
State/province [9] 0 0
Utrecht

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 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04984356
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jan Davidson, 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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries