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Clinical Trial 21696

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04984356

Phase: Phase I
Principal Investigator: Faramand, Rawan

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 1/2 Dose-Escalation and Dose-Expansion 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 /Lymphoblastic Lymphoma (T-ALL)/Lymphoblastic Lymphoma (LBL)

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).

Objective

Primary Objectives: To characterize the safety, tolerability, DLT, and MTD or MAD (if no MTD is defined) and define the RP2D of WU-CART-007 in T-ALL/LBL (Phase 1). To investigate the preliminary anti-tumor activity, as measured by objective response rate (ORR) and duration of response (DOR) of WU-CART-007 in relapsed or refractory (R/R) T-ALL/LBL patients (Phase 2). ORR is defined as proportion of patients that achieve CR + CRi. Secondary Objectives: To investigate the preliminary effect on overall survival (OS) and progression-free survival (PFS). To evaluate preliminary anti-tumor activity as measured by Complete Remission (CR) rate defined as proportion of patients that achieve a CR. To determine rate of successful transition to HCT in eligible patients. Exploratory Objectives: To valuate persistence and immunophenotype (cellular kinetics) of WU-CART-007 in blood and bone marrow over time. To evaluate the immunogenicity of WU-CART-007 i.e., development of anti-CAR antibodies. To understand the assessment of CD7 expression as it relates to clinical response in the treatment of relapsed or refractory T-ALL/LBL as measured by flow cytometry. To explore the tumor microenvironment (TME) by measuring mRNA and protein levels of immune markers before and after treatment with WU-CART-007 in T-ALL/LBL. To evaluate cytokines/chemokines levels before, during and after treatment with WU-CART-007. To evaluate utility of MRD, in subjects achieving a CR, in the context of WU-CART-007 treatment in T-ALL/LBL.

Treatments

Therapies

Cell Therapy; Chemotherapy (NOS)

Medications

Cladribine (); WU-CART-007 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

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 veno-occlusive disease (VOD), 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

Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent.

Willing to participate in WUC-007-02 for long-term follow up.

Exclusion Criteria

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.

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 (except daratumumab)

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