IMJ995 in Acute Lymphoblastic Leukemia

• Status: Not yet recruiting
• Trial end date: 2025-06-04
• Target enrollment: 0
• Participant gender: All

Summary

This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a CD19/CD22-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated as single agent in pediatric and adult acute lymphoblastic leukemia (ALL).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

All patients:

• Evidence of CD19 and/or CD22 cell surface expression on B-ALL blasts in bone marrow or peripheral blood by flow cytometry at time of relapse or prior to study entry.

Pediatric, adolescent and young adult ALL patients:

• 1 - 29 years of age at the time of informed consent form (ICF) signature.

• Relapsed or refractory CD19+ and/or CD22+ ALL after 3 or more lines of treatment OR after allogeneic HCT.

• Must have received a CD19-directed CAR-T treatment (with or without blinatumomab), unless prior loss of CD19 cell surface expression occurred or have not been eligible for CD19 directed CAR-T treatment.

• Lansky (age < 16 years), Karnofsky (age 16-25 years) performance status ≥ 60%. ECOG (age >25 years) performance status that is either 0 or 1 at screening.

Adult ALL patients aged ≥30 years:

• ≥30 years of age at the time of informed consent form (ICF) signature.

• Refractory or relapsed CD19+ and/or CD22+ ALL including at least one of the following:

• After allogeneic HCT

• After 2 or more lines of treatment, including blinatumomab and/or inotuzumab

• Primary refractory disease (defined as failure to achieve a CR at the end of at least 1 induction chemotherapy)

• First relapse occurring within 12 months from first remission

• ECOG performance status that is either 0 or 1 at screening.

Exclusion Criteria:

• Allogeneic HCT within 12 weeks prior to screening.

• Presence of isolated extra-medullary disease, testicular involvement or bulky disease

• Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome.

• Patients with Burkitt's lymphoma/leukemia

• History of active neurological auto immune or inflammatory disorders

Other protocol-defined inclusion/exclusion criteria may apply.