Clinical Trials Actively Recruiting

Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below.

Results 1 - 10 of 57

  • Objective:

    Primary Objectives:

    • To investigate the safety of monotherapy and T- Plex combination TCR-Ts
    • To determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts

    Secondary Objectives:

    • To investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts
    • To investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts
    Cancer Categories:
    • Gynecologic,Hematologic (Blood Cancers),Lung,Skin
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2023-086
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    BGB-16673 Monotherapy Dose Finding (Phase 1)

    Primary Objectives:

    • To evaluate the safety and tolerability of BGB-16673 monotherapy
    • To define the maximum tolerated dose (or maximum assessed dose) and the
      recommended Phase 2 dose (RP2D) of BGB-16673

    Secondary Objectives:

    • To characterize the pharmacokinetic profile of BGB-16673 as monotherapy
    • To characterize the pharmacodynamic profile of BGB-16673 in peripheral blood
    • To characterize the preliminary antitumor activity of BGB-16673 monotherapy

    BGB-16673 Monotherapy (Phase 2)

    Primary Objectives:

    • To evaluate the antitumor activity of BGB-16673 monotherapy in patients with
      relapsed/refractory (R/R) mantle cell lymphoma (MCL) based on overall response
      rate (ORR) as assessed by an Independent Review Committee (IRC)
    • To evaluate the antitumor activity of BGB-16673 monotherapy in patients with R/R
      CLL/SLL based on ORR as assessed by investigators

    Secondary Objectives:

    • To evaluate the safety and tolerability of BGB-16673 monotherapy
    • To further characterize the pharmacokinetic profile of BGB-16673
    • To further characterize the pharmacodynamic profile of BGB-16673 in peripheral
      blood
    • Patients with R/R MCL:
      • To evaluate the antitumor activity of BGB-16673 monotherapy based on ORR as
        assessed by investigators
      • To evaluate the antitumor activity of BGB-16673 monotherapy based on best
        overall response (BOR), time to response (TTR), duration of response (DOR), and
        progression-free survival (PFS) as assessed by the IRC and investigators
      • To characterize overall survival
      • To measure patient-reported outcomes (PRO) in R/R MCL patients via National
        Comprehensive Cancer Network Functional Assessment of Cancer Therapy –
        Lymphoma System Index-18 (NFLymSI-18)
    • Patients with R/R CLL/SLL:
      • To evaluate the antitumor activity of BGB-16673 monotherapy based on ORR,
        DOR, TTR, and PFS as assessed by investigators
      • To characterize overall survival
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Modi, Dipenkumar
    Karmanos Trial ID:
    • 2023-094
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Phase 1 Dose Escalation

    Primary Objectives:

    • To evaluate the safety and tolerability of CA-4948 in patients with R/R AML and
      hrMDS
    • To identify the MTD and RP2D

    Secondary Objectives:

    • To characterize the PK parameters of CA-4948 using non-compartmental analysis
      and appropriate PK modelling
    • To assess anti-cancer activity

    Phase 2a Dose Expansion

    Primary Objective:

    • To assess anti-cancer activity of CA-4948 at RP2D in patients with R/R AML with
      FLT-3 mutations, and patients with R/R hrMDS or R/R AML with spliceosome
      mutations of SF3B1 or U2AF1

    Secondary Objectives:

    • To assess tolerability and long-term safety
    • To further assess anti-cancer activity of CA-4948 at RP2D
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Yang, Jay
    Karmanos Trial ID:
    • 2023-095
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objective:

    • To compare overall survival in MCL patients in MRD-negative first complete remission (CR) who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone (without auto- HCT).

    Secondary Objectives:

    • To compare progression-free survival in MCL patients in MRDnegative CR who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone.
    • To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive CR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.
    • To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.
    • To define the overall survival and progression-free survival at 2 and 5 years of MRD-negative PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.
    • To define the overall survival and progression-free survival at 2 and 5 years of MRD-indeterminate patients who undergo auto-HCT followed by 3 years of maintenance rituximab.
    • To describe the rate of complications (serious infection, hospitalization, need for intravenous immune globulin) in MCL patients undergoing maintenance rituximab following auto-HCT.
    • To determine the prognostic impact of MRD status at day 100, in MCL patients who were MRD-positive (including MRD-positive CR and MRD-positive PR) prior to auto-HCT.
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Uberti, Joseph
    Karmanos Trial ID:
    • EA4151/BMTCTN1601
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:
    Primary Objective:
    • To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients.
    Secondary Objectives of First Randomization:
    • To compare the best overall response rate (ORR), including partial remission (PR), very good partial remission (VGPR), and complete remission (CR, sCR) in the subset of patients not in PR at randomization to lenalidomide versus lenalidomide + daratumumab/rHuPH20 in this patient population.
    • To compare progression-free survival (PFS) between the study arms in this patient population.
    • To evaluate MRD-negativity on the two treatment arms at randomization (Registration Step 2), and to compare MRD-negativity rate at 12, 24 (second randomization), 36, and 48 months after first randomization between lenalidomide and lenalidomide + daratumumab/rHuPH20 in this patient population.
    • To compare toxicities and tolerability of long term therapy between the study arms.
    Objectives of Second Randomization:
    • To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide vs. discontinued lenalidomide from the time of second randomization in this patient population.
    • To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide + daratumumab/rHuPH20 vs. discontinued lenalidomide + daratumumab/rHuPH20 from time of second randomization in this patient population.
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Kin, Andrew
    Karmanos Trial ID:
    • S1803
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Primary Objectives:

    • To establish the safety and tolerability of LYT-200 as a single treatment
    • To recommend the dose or doses of LYT-200 for Phase 2 (RP2D)
    • To determine the incidence of DLTs during Cycle 1 (28 days) across dose levels

    Secondary Objectives:

    • To determine the preliminary efficacy of LYT- 200 as a single treatment
    • To characterize the PK profile of LYT-200
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Yang, Jay
    Karmanos Trial ID:
    • 2023-015
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    Evaluate safety and tolerability of SC291

    • Dose-limiting toxicities (DLTs)
    • Treatment-emergent adverse events (TEAEs)
    • Treatment-related adverse events (TRAEs)
    • Targeted adverse events (TAEs)
    • Adverse Events of Special Interest (AESIs)

    Secondary Objectives:

    Evaluate preliminary anti-tumor activity of SC291

    • Objective response
    • Duration of response (DOR)
    • Time to next treatment
    • Progression free survival (PFS)
    • Event free survival (EFS)
    • Overall survival (OS)

    Evaluate cellular kinetics and persistence of SC291

    • Cellular kinetics (CK)-related parameters evaluated by CAR copy number (CAR VCN): peak observed in peripheral blood after administration (Cmax), time of first occurrence of maximum-observed concentration (Tmax), terminal disposition phase half-life (t1/2), last observed quantifiable concentration in peripheral blood (Clast), time of last observed quantifiable concentration in peripheral blood (days) (Tlast), area under the concentration-time curves (AUCs)

    Evaluate host immunogenicity to SC291

    • Humoral immunogenicity assessment (anti-CD19-directed CAR)
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Deol, Abhinav
    Karmanos Trial ID:
    • 2023-012
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    • To evaluate the safety and tolerability of FT522 in combination with rituximab, with or without conditioning chemotherapy
    • To determine the RP2D for FT522 in combination with rituximab, with or without conditioning chemotherapy

    Secondary Objectives:

    • To evaluate the anti-tumor activity of FT522 in combination with rituximab, with or without conditioning chemotherapy
    • To characterize the PK of FT522 in combination with rituximab, with or without conditioning chemotherapy
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Deol, Abhinav
    Karmanos Trial ID:
    • 2023-042
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives

    Phase 1:

    • Assess safety and tolerability of ISB 1442
    • Determine maximum tolerated dose (MTD) and/or RP2D

    Phase 2

    • Evaluate efficacy of ISB 1442

    Secondary Objectives

    • Characterize the PK profile of ISB 1442
    • Characterize immunogenicity of ISB 1442

    Phase 1:

    • Assess preliminary efficacy of ISB 1442

    Phase 2:

    • Assess safety and tolerability of ISB 1442
    • Further characterize efficacy of ISB 1442
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Zonder, Jeffrey
    Karmanos Trial ID:
    • 2023-019
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary Objective:

    • To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ST-001 12.5 mg/mL for IV infusion (ST-001) in patients with Relapsed/Refractory T-cell non-Hodgkin’s lymphoma when ST-001 is administered via 4-hour IV infusion daily for five consecutive days, q3weeks.

    Secondary Objectives:

    • To describe the toxicity profile of ST-001 in patients with CTCL and other T-cell NHL.
    • To observe and record anti-tumor activity. The previous activity seen with an earlier formulation of fenretinide in the same patient population suggests a likelihood of therapeutic benefit. Thus, patients will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.
    • To investigate the clinical pharmacology of ST-001 12.5 mg/mL for IV infusion.
    • To describe the pharmacokinetics of fenretinide when ST-001 is administered by daily infusion for 5 consecutive days every 3 weeks.
    • To evaluate potential mechanisms of action of ST-001 with pharmacodynamic biomarkers:
      • ST-001 increases CTCL cell surface expression of NKG2D receptor ligands, while reducing expression of immunosuppressive cytokines, thereby increasing cytolysis by both CD8+ CTLs and NK cells
      • ST-001 reduces expression of cytokine ligands for IL-2, -15, -21 receptors, thereby reducing CTCL proliferation driven by constitutive over-expression of the IL2RA subunit
    Cancer Categories:
    • Hematologic (Blood Cancers)
    Principal Investigator:
    • Modi, Dipenkumar
    Karmanos Trial ID:
    • 2023-056
    Age Group:
    • Adult
    Phase:
    • Phase I