Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells — BAH246

T-cell Acute Lymphoblastic Leukemia Clinical Trial

Official title:
This is an Open, Single-arm, Clinical Study to Evaluate the Efficacy and Safety of Anti-CD7/CD5 CAR-T Cells in the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL), ETP-ALL, and Lymphoblastic Lymphoma (TLBL).

Status Not yet recruiting

Clinical Trial Summary

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5/CD7 in patients with patients with relapsed or refractory T-ALL/LBL/ETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.

Clinical Trial Description

Acute lymphoblast leukemia (T-ALL) is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells. The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However, once the disease appears to be relapsed/refractory, there are limited treatment options, and the overall prognosis is extremely poor. Therefore, exploring safe and effective treatments is a critical unmet medical need. The patients will receive Sequential CAR-T Cells Targeting CD5/CD7 to examine the safety and, possibly the efficacy of CD5 CAR T-Cells in CD5+ CD7+ relapsed or refractory acute leukemia. ;

Study Design

Related Conditions & MeSH terms

Leukemia
Leukemia, Lymphoid
Leukemia, Prolymphocytic
Leukemia, Prolymphocytic, T-Cell
Leukemia, T-Cell
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
T Cell Leukemia
T Cell Lymphoma
T-cell Acute Lymphoblastic Leukemia

Clinical Trial Details

NCT number	NCT06420076
Study type	Interventional
Source	Essen Biotech
Contact	JAMAL ALKHAYER
Phone	+97333799773
Email	ceo@essen-biotech.com
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	September 10, 2024
Completion date	December 28, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05032599` - Donor-Derived CD5 CAR T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia	Phase 1
Recruiting	`NCT04033302` - Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies	Phase 1/Phase 2
Recruiting	`NCT05995028` - Universal 4SCAR7U Targeting CD7-positive Malignancies	Phase 1
Recruiting	`NCT05596266` - CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia	Phase 1
Completed	`NCT01950286` - Hyper-CVAD Treatment of Adult T-cell Acute Lymphoblastic Leukemia in Sweden.	N/A
Completed	`NCT02518113` - A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL	Phase 1/Phase 2
Recruiting	`NCT03081910` - Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen	Phase 1
Recruiting	`NCT05290155` - Anti-CD7 CAR-T Cell Therapy for Relapse and Refractory CD7 Positive T Cell Malignancies	Phase 1
Recruiting	`NCT05289687` - Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL	Phase 2
Recruiting	`NCT04972942` - Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma	Phase 1
Recruiting	`NCT06316427` - Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma	Phase 1/Phase 2
Recruiting	`NCT05277753` - NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL	Phase 1
Not yet recruiting	`NCT06390319` - Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)	Phase 2
Recruiting	`NCT05679895` - Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL	Phase 1
Active, not recruiting	`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	Phase 1/Phase 2
Recruiting	`NCT05832125` - Registry of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia
Withdrawn	`NCT04860817` - A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL	Early Phase 1
Recruiting	`NCT04594135` - Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies	Phase 1
Recruiting	`NCT04934774` - Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances	Phase 1
Enrolling by invitation	`NCT05509855` - A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.