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
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|ClinicalTrials.gov Identifier: NCT04984356|
Recruitment Status : Recruiting
First Posted : July 30, 2021
Last Update Posted : March 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|T-cell Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma||Biological: WU-CART-007||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||
There are two parts to this study. Phase 1 will comprise of Dose Escalation, and Phase 2 Cohort Expansion.
Phase 1 will determine the safety and tolerability of a single dose of WU-CART-007 and define the RP2D.
The Cohort Expansion Phase, will further define the safety and evaluate the initial efficacy of WU-CART-007 at the dose established from the Phase 1 Dose Escalation segment.
|Masking:||None (Open Label)|
|Official 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)|
|Actual Study Start Date :||January 14, 2022|
|Estimated Primary Completion Date :||May 2026|
|Estimated Study Completion Date :||August 2026|
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. Cyclophosphamide 500 mg/m2/day x 3 (days -5 to -3) Fludarabine 30 mg/m2/day x 3 (days -5 to -3)
A single IV infusion of WU-CART-007 Cells on Day 1
- 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
- Maximum Tolerated Dose (MTD) [ Time Frame: up to 28 days from first dose ]Maximum tolerated or administered dose of WU-CART-007
- Overall Response Rate (ORR) [ Time Frame: 24 months ]ORR is defined as proportion of patients that achieve complete remission (CR) + complete remission with incomplete hematologic recover ( CRi)
- 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
- Progression Free Survival [ Time Frame: 24 months ]Time from study drug administration (Day 1) to disease progression
- Overall Survival [ Time Frame: 24 months ]Time from study drug administration (Day 1) to death on study
- Hematopoietic Stem Cell Transplant (HSCT) rate [ Time Frame: 24 months ]Rate of successful transition to HSCT through study treatment
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984356
|Contact: Eileen McNulty, MSfirstname.lastname@example.org|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
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|Saint Louis, Missouri, United States, 63110|
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|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator: Shannon Maude, MD|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37212|
|Contact: Bhagirathbhai Dholaria, MD email@example.com|
|Principal Investigator: Bhagirathbhai Dholaria, MD|
|United States, Wisconsin|
|University of Wisconsin||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator: Ryan Mattison, MD|
|Peter MacCallum Cancer Centre||Recruiting|
|Melbourne, Victoria, Australia|
|Study Director:||Ken Jacobs, MD||Wugen, Inc.|
|Responsible Party:||Wugen, Inc.|
|Other Study ID Numbers:||
|First Posted:||July 30, 2021 Key Record Dates|
|Last Update Posted:||March 8, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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