CompletedPhase 1

Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy

United States17 participantsStarted 2021-08-06

Plain-language summary

This is a multicenter Phase 1b study evaluating the safety, tolerability, and preliminary anti-tumor activity of NT-I7 administration following standard of care CD19 CAR T-cell therapy for eligible subjects with r/r LBCL.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects must have a life expectancy of greater than or equal to 12 weeks per assessment from the enrolling physician.
✓. Adequate organ and marrow function per institutional guidelines at the start of lymphodepleting chemotherapy as pre-conditioning for SOC CD19 CAR T-cell infusion.

Exclusion criteria

✕. Hemoglobin ≥8.0 g/dL or ≥4.96 mmol/L
✕. Absolute neutrophil count ≥1,000/µL
✕. Platelets \>50,000/µL
✕. Total bilirubin ≤1.5 × institutional upper limit of normal (ULN) OR direct bilirubin ≤ULN for subjects with total bilirubin levels \>1.5 × ULN, except subject with documented Gilbert's syndrome (\>3 x ULN), who must have a baseline total bilirubin ≤ 3.0 mg/dL
✕. AST(SGOT)/ALT(SGPT) ≤2.5 × ULN (AST and/or ALT ≤5 × ULN for subjects with liver metastasis)
✕. Alkaline phosphatase ≤2.5 × ULN (≤5 × ULN for subjects with documented liver involvement or bone metastases)
✕. Creatinine clearance (CrCl) ≥30 mL/min as calculated per institutional standard.
✕. INR and aPTT ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants 10. Female subjects who are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks; female subjects of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to use dual methods of contraception for the duration of study treatment and for 90 days after NT-I7 injection, whichever is longer. Female subjects of childbearing potential (including women who have had a tubal ligation) must have a negative serum or urine pregnancy test within 72 hours prior to NT-I7 injection. If the urine test is positive, or cannot be confirmed as negative, a serum pregnancy test will be required.

What they're measuring

For Dose Escalation Phase: Incidence of adverse events (AE)

Timeframe: 21 Days

Incidence of Dose Limiting Toxicities (DLT)

Timeframe: 21 Days

To determine the Maximum Tolerated Dose (MTD)

Timeframe: 21 Days

To determine the Recommended Phase 2 Dose (RP2D)

Timeframe: 21 Days

Trial details

NCT IDNCT05075603

SponsorNeoImmuneTech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-18

View on ClinicalTrials.gov More Refractory Diffuse Large B-cell Lymphoma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects must have a life expectancy of greater than or equal to 12 weeks per assessment from the enrolling physician.
✓. Adequate organ and marrow function per institutional guidelines at the start of lymphodepleting chemotherapy as pre-conditioning for SOC CD19 CAR T-cell infusion.

Exclusion criteria

✕. Hemoglobin ≥8.0 g/dL or ≥4.96 mmol/L
✕. Absolute neutrophil count ≥1,000/µL
✕. Platelets \>50,000/µL
✕. Total bilirubin ≤1.5 × institutional upper limit of normal (ULN) OR direct bilirubin ≤ULN for subjects with total bilirubin levels \>1.5 × ULN, except subject with documented Gilbert's syndrome (\>3 x ULN), who must have a baseline total bilirubin ≤ 3.0 mg/dL
✕. AST(SGOT)/ALT(SGPT) ≤2.5 × ULN (AST and/or ALT ≤5 × ULN for subjects with liver metastasis)
✕. Alkaline phosphatase ≤2.5 × ULN (≤5 × ULN for subjects with documented liver involvement or bone metastases)
✕. Creatinine clearance (CrCl) ≥30 mL/min as calculated per institutional standard.
✕. INR and aPTT ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants 10. Female subjects who are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks; female subjects of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or to use dual methods of contraception for the duration of study treatment and for 90 days after NT-I7 injection, whichever is longer. Female subjects of childbearing potential (including women who have had a tubal ligation) must have a negative serum or urine pregnancy test within 72 hours prior to NT-I7 injection. If the urine test is positive, or cannot be confirmed as negative, a serum pregnancy test will be required.