Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allo… (NCT05377827) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies
United States6 participantsStarted 2023-10-10
Plain-language summary
Effective treatment options for relapsed/refractory acute myeloid leukemia (AML) and T-cell non-Hodgkin lymphoma (T-NHL) represent a significant unmet medical need. CAR T therapy has offered durable remissions and potential cures in some forms of hematologic malignancy, including B-cell acute lymphoblastic leukemia. In AML, however, CAR T approaches have been limited by the lack of suitable antigens, as most myeloid markers are shared with normal hematopoietic stem cells and targeting of these antigens by CAR T therapy leads to undesirable hematologic toxicity. Similarly, T-NHL has not yet benefited from CAR T therapy due to a lack of suitable markers. One potential therapeutic target is CD7, which is expressed normally on mature T-cells and NK-cells but is also aberrantly expressed on \~30% of acute myeloid leukemias. CAR T therapy for patients with CD7+ AML and T-NHL will potentially offer a new therapeutic option which has a chance of offering durable benefit.
WU-CART-007 is a CD7-directed, genetically modified, allogeneic, fratricide-resistant chimeric antigen receptor (CAR) T-cell product for the treatment of CD7+ hematologic malignancies. These cells have two key changes from conventional, autologous CAR T-cells. First, because CD7 is present on normal T-cells including conventional CAR T products, CD7 is deleted from WU CART-007. This allows for targeting of CD7 without the risk of fratricide (killing of WU-CART-007 cells by other WU-CART-007 cells). Second, the T cell receptor alpha constant (TRAC) is also deleted. This makes WU CART 007 cells incapable of recognizing antigens other than CD7 and allows for the use of an allogeneic product without causing Graft-versus-Host-Disease (GvHD).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Specific criteria apply to T-NHL patients (Cohort A) and leukemia patients (Cohort B):
In general, all patients must have CD7 expression and confirmed diagnoses of T-cell non Hodgkin lymphoma or acute myeloid leukemia (any subtype except acute promyelocytic leukemia) according to World Health Organization (WHO) classification29, and have relapsed or refractory disease.
Inclusion Criteria for Cohort A:
* Patients will have T-cell non-Hodgkin lymphoma with relapsed or refractory disease defined as one of the following:
* Relapsed or refractory after at least 2 or more prior lines of therapy (for patients with anaplastic large cell lymphoma, they must have prior therapy brentuximab vedotin). For patients with T-PLL, only 1 or more prior line of therapy is required. OR
* Relapsed after autologous or allogeneic hematopoietic cell transplant.
* Permissible T-cell NHL subtypes will include:
* angioimmunoblastic T-cell lymphoma (AITL)
* enteropathy-associated T-cell lymphoma (EATL)
* monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)
* peripheral T-cell lymphoma (PTCL) NOS
* anaplastic large cell lymphoma (ALCL)
* adult T-cell leukemia/lymphoma
* T-cell prolymphocytic leukemia (T-PLL)
* extranodal NK/T cell lymphoma
* transformed mycosis fungoides/Sezary Syndrome
* primary cutaneous gamma/delta T-cell lymphoma
* hepatosplenic T cell lymphoma
Inclusion Criteria for Cohort B:
* Patients will have Acute Myeloid Leukemia (AML) (acute leukemia …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial that's still figuring out the right dose of WU-CART-007 — what does that mean for what's currently known about how safe and effective this treatment might be for someone with my specific diagnosis?
2Since WU-CART-007 is an 'allogeneic' CAR T-cell therapy made from donor cells rather than my own, how does that affect the risks compared to standard CAR T-cell treatments, and are there risks like graft-versus-host disease or immune reactions I should specifically ask about?
3The trial is listed as 'active not recruiting' — does that mean enrollment is closed, and if so, are there similar CAR T-cell studies targeting CD7 that might still be open to me?
4This trial targets a protein called CD7 on cancer cells — has my tumor been tested to confirm it expresses CD7, and how important is that result for whether this approach could even be worth considering for my case?
5Given that this trial is measuring things like complete remission and metabolic response as its goals, what would my treatment path look like if WU-CART-007 didn't work, and is there a standard therapy option I should consider first before exploring an experimental Phase 1 study like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recommended phase II dose (Dose Escalation only)
Timeframe: Through completion of day 42 for all Part A participants (estimated to be 18 months and 42 days)
2
Number of participants with complete metabolic response or partial metabolic response (Dose expansion only - Cohort A)
Timeframe: Through completion of response assessments (estimated to be 24 months)
3
Number of participants with complete remission, complete remission with incomplete blood count recovery, complete remission with partial hematologic recovery, or morphologic leukemia free state (Dose expansion only - Cohort B)
Timeframe: Through completion of response assessments (estimated to be 24 months)