Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)

PHASE2RECRUITING

The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response.

Study details:

This is a Phase 2, single-arm, multi-center, open label study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive
Lower age limit of ≥ 1 year; adequate organ function
Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening (Adults age > 16) or Lansky Performance Status 70 and above (pediatrics/ adolescents age ≤16).

Exclusion criteria

Treatment with any prior anti-CD7 therapy.
Patients with decompensated hemolytic anemia.
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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE2

Study ID

NCT06514794

Intervention or treatment

BIOLOGICAL: WU-CART-007

Conditions

T-cell Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma

Condition: T-cell Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
BIOLOGICAL: WU-CART-007
Melbourne, Victoria, Australia and more
Sponsor: Wugen, Inc.

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Peter Mac Callum Cancer Institute

Select from list below to view details:

Peter Mac Callum Cancer Institute
Melbourne, Victoria, Australia
Royal Children's Melbourne
Melbourne, Victoria, Australia

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Who is running the clinical trial?

Wugen, Inc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: WU-CART-007 A CD7-directed chimeric antigen receptor (CAR) T-cell product. Lymphodepletion	Biological: WU-CART-007

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
R/R Cohort - Composite Complete Response Rate	CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi)	24 months
MRD Pos Cohort - Response Rate	Defined as the efficacy of WU-CART-007 to induce complete MRD negative response	24 months

Secondary Outcome

Are you running this trial?If you're a clinic or sponsor, you can claim this study.

Claim this trial

References

Clinical Trials Gov: A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)

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