- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04984356
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
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)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Eileen McNulty, MS
- Phone Number: 636-385-5306
- Email: emcnulty@wugen.com
Study Locations
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Victoria
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Melbourne, Victoria, Australia
- Recruiting
- Peter MacCallum Cancer Centre
-
Contact:
- Email: enquiry@petermac.org
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-
-
-
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Paris, France
- Not yet recruiting
- Hospital Saint- Louis
-
Principal Investigator:
- Nicolas Boissel, MD PhD
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Contact:
- Nicolas Boissel
- Email: nicolas.boissel@aphp.fr
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Paris, France
- Not yet recruiting
- University Hospital Robert Debre
-
Principal Investigator:
- Andre Baruchel, MD
-
Contact:
- Delphine Chaillou
- Email: delphine.chaillou@aphp.fr
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Rotterdam, Netherlands
- Not yet recruiting
- Erasmus MC
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Principal Investigator:
- Anita Rijneveld, MD
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Utrecht, Netherlands
- Recruiting
- Prinses Maxima Centrum
-
Principal Investigator:
- Friso Calkoen, MD
-
-
-
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California
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope
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Contact:
- Phone Number: 877-467-3411
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Principal Investigator:
- Ibrahim Aldoss, MD
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Los Angeles, California, United States, 90027
- Recruiting
- Children's Hospital Los Angeles
-
Principal Investigator:
- Deepa Bhojwani, MD
-
-
Florida
-
Tampa, Florida, United States, 33612
- Recruiting
- Moffit Cancer Center
-
Contact:
- Rawan Faramand, MD
- Email: rawan.faramand@moffitt.org
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Principal Investigator:
- Rawan Faramand, MD
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University
-
Contact:
- Katie Stricker
- Phone Number: 314-273-4902
- Email: kstricker@wustl.edu
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Principal Investigator:
- Armin Ghobadi, MD
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia
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Principal Investigator:
- Shannon Maude, MD
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Tennessee
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Nashville, Tennessee, United States, 37212
- Recruiting
- Vanderbilt University
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Principal Investigator:
- Bhagirathbhai Dholaria, MD
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Contact:
- Bhagirathbhai Dholaria, MD
- Email: Bhagirathbhai.r.dholaria@vumc.org
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Recruiting
- University of Wisconsin
-
Principal Investigator:
- Ryan Mattison, MD
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key Inclusion/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:
- Primary refractory: failure to achieve CR after induction chemotherapy, per investigator.
- Early Relapse: relapsed disease within 12 months of initial diagnosis.
- Late Relapse (relapsed refractory disease): relapsed disease after 12 months of initial diagnosis AND failure of re-induction therapy after disease recurrence.
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
A single IV infusion of WU-CART-007 Cells on Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5
Time Frame: 24 months
|
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until end of study visit
|
24 months
|
Maximum Tolerated Dose (MTD)
Time Frame: up to 28 days from first dose
|
Maximum tolerated or administered dose of WU-CART-007
|
up to 28 days from first dose
|
Composite Complete Response Rate
Time Frame: 24 months
|
Defined as proportion of patients that achieve a complete remission (CR) + complete remission with incomplete hematologic recover ( CRi) + CR with partial hematologic recovery (CRh)
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 24 months
|
Time from study drug administration (Day 1) to death on study
|
24 months
|
Hematopoietic Stem Cell Transplant (HSCT) rate
Time Frame: 24 months
|
Rate of successful transition to HSCT through study treatment
|
24 months
|
Objective Response Rate
Time Frame: 24 months
|
ORR is defined as proportion of patients that achieve complete remission (CR) + complete remission with incomplete hematologic recover ( CRi) + CR with partial hematologic recovery (CRh), morphologic leukemia free state (MLFS, and partial response (PR) in patients with EMD only
|
24 months
|
Duration of Response
Time Frame: 24 months
|
Time of response to the time of disease relapse, progression or death due to any cause.
whichever occurs first
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jan Davidson, MD, Wugen, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WU-CART-007 1001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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